Type 2 Diabetes Mellitus (T2DM)GAPNCT02002143
GMVs in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People
A study testing Group Appointments and Individual Appointments (IAs) in people with Type 2 Diabetes Mellitus (T2DM), run by University of British Columbia at 2 sites in Canada.
Trial summary
Type 2 diabetes is a major problem of older people; its prevalence is greater than 20% in those aged over 65 years. Treatment such as medication, healthy nutritional choices \& body weight management, as well as physical activity can reduce the impact of diabetes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Group Appointments and Individual Appointments (IAs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2014to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged ≥ 65 years old;
- have at least a 12-month history of T2DM based on the Canadian Diabetes Guidelines;
- be community-dwelling;
- live within 30km of their GP clinic in Abbotsford, BC (Canada);
- able to comply with scheduled visits, treatment plan, and other trial procedures;
- read, write, and speak English;
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- acceptable auditory acuity to participate in the Group Appointments and visual acuity to participate in the research;
- provide a personally signed and dated informed consent;
- able to walk independently;
- Inclusion will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician, indicating the patient's appropriateness to participate.
Who cannot join
- using insulin to treat diabetes to increase the homogeneity of the sample;
- at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
- Mini-Mental State Examination (MMSE)[51] score of ≤ 24 at screening;
- have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
- taking medications that may negatively affect the ability to undertake a simple walking program safely (e.g. beta blockers);
- planning to participate, or already enrolled in, a clinical drug trial concurrent to this study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Gateway Clinic / Kent Place Clinic
Abbotsford British Columbia, British Columbia, V2S 3N5
Adriaan Windt, MD
- Recruiting
Centre for Hip Health and Mobility (Vancouver Coastal Health Research Institute/University of British Columbia)
Vancouver, British Columbia, V5Z 1M9
Karim Miran-Khan, MD, PhD, MBA
About this study
Official title: Group Medical Visits (GMVs) in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People
Type 2 diabetes is a major problem of older people; its prevalence is greater than 20% in those aged over 65 years. Treatment such as medication, healthy nutritional choices \& body weight management, as well as physical activity can reduce the impact of diabetes.
Older patients with type 2 diabetes can potentially benefit from Group Appointments, in which 8-12 patients share one appointment of about 60-120 minutes with a team of health professionals.
Read more
The team of investigators (3 people) will see the 'Group' 4 times/yr for two years. Their key measure of success will be control of glycosylated hemoglobin - HbA1C.
To address their primary and secondary research objectives the investigators will focus upon patients aged 65 years or older who have T2DM and who are being treated with oral hypoglycemic agents and diet, or diet alone.
The investigators will compare patients randomized to (A) eight Group Appointments over a 24 month period (i.e., 4 per year), led by a primary care physician [Intervention] with, (B) patients randomized to eight traditional one-to-one usual care appointments also provided by a primary care physician (Individual Appointment; [Control]). The investigators will compare (A) and (B) on selected clinical, patient-rated, and economic outcome measures.
SIGNIFICANCE: Seven Canadian provinces already have Group Appointment billing codes for physicians who lead Group Appointments. If the study's proposed health care innovation demonstrates benefits, it would be possible to 'roll out' / 'scale up' the model province- or nation-wide in Primary Care settings.
Read the detailed description
Type 2 diabetes mellitus (T2DM) in older people is an undisputed health problem. More than 1.1 million people diagnosed with diabetes mellitus (DM) in Canada are over the age of 65 years. Rates of T2DM in older people are accelerating even when adjusted for age. Thus, total community prevalence is increasing based on the greater number of older people, an increased rate among those older people, and improved survival rates of people with DM.
The financial burden of DM to the Canadian health care system will approach $17 billion/year by 2020. Beyond the direct health burden of T2DM, the condition is an independent risk factor for falls and dementia -two of the 'geriatric giants'. T2DM is 'an important unresolved issue previously unacknowledged' and is considered to increase 'biological age' by 2 years in those aged over 70 years.
Although treatment can improve the clinical trajectory of older people with T2DM, many do not receive guideline care. Combinations of drug treatment, physical activity, nutrition advice and body weight management, reduce risk factors, delay onset of disease and lessen the rate of complications.
Group Appointments (GAs) - also called Group Medical Visits or Shared Medical Appointments may contribute to improved T2DM care for older people in the primary care setting. The innovation in this study is to undertake research in one study to determine 1) the clinical effectiveness; 2) quality of life; and 3) economic implications of Group Appointments for older people with T2DM.
'Group Appointments' exist in various forms. Their origin is often attributed to Noffsinger and also Ward. In a Group Appointment, one physician works with a nurse and a 'behaviourist' (described on page 12c) to care for eight to twelve patients during one 60-120 minute appointment.
A recent Systematic Review of Group Appointments in T2DM performed by two current Co-Investigators (HOUSDEN, DAWES) highlighted the need for a Canadian Primary Care RCT that would extend previous research from Italy. The extension of research by this study is to have a Primary Care physician lead Group Appointments and for the RCT to include exclusively men and women aged 65 years and older.
The clinical and societal importance of T2DM in older people is not disputed. 'Diabetes mellitus is a serious condition with potentially devastating complications that affects all age groups worldwide'.
Diabetes epidemiology was reviewed in the 2013 Canadian Diabetes Practice Guidelines and Public Health Agency of Canada's 'Diabetes in Facts \& Figures'. To make this literature 'critical' the investigators will focus on 1) the accelerating rate of diagnosis of type 2 diabetes in older people; 2) the challenge of delivering quality diabetes care affordably in a traditional one-to-one primary care encounter 3) the equipoise that results from international evidence for testing GAs to improve patient self-management in the absence of Canadian Primary Care research in this field; 4) a brief review of the validity and limitations of HbA1C as a measure of T2DM self-management; and 5) the theoretical framework underpinning their Group Appointment intervention.
From the 2013 Canadian Clinical Practice Guidelines for Diabetes, as of 2009, 6.8% of Canadians (2.4 million people) had the condition. This represented a 230% increase compared to prevalence estimates 11 years earlier. A decade from now, an additional 1.3 million Canadians are expected to have T2DM. Diabetes and its complications increase costs and service pressures on Canada's publicly funded healthcare system. People with diabetes were three times more likely to require hospital admission in the preceding year with longer lengths of stay.
Good metabolic control of diabetes prevents complications. This requires lifestyle and behavioural modification. In Canada, the usual clinical care for diabetes is via individual patient consultations combined with 'ad hoc' educational advice during a family practice appointment or referral to an educational support program, if available. Although traditional primary care delivery addresses clinical problems, it fails to embrace the principles of behaviour change (compliance/ adherence) that are an essential part of chronic disease management.
The Canadian Practice Guidelines for T2DM call for psychological support, exercise promotion and nutritional advice. Traditional one-to-one clinical encounters in a fee-for-service setting do not encourage such coordinated care. There is a call to improve the scope of diabetes care currently offered in Canada. The quote 'if you keep doing what you've always done, you'll keep getting what you've always got' is relevant in this setting.
Traditional one-to-one clinical encounters will always have a place in health service delivery.
However, given the common needs across patients and the burgeoning costs to treat those with T2DM - the investigators address the question, 'Is there a more effective way to encourage successful patient self-management for older people with T2DM.
Two major resources on Group Appointments relate to various medical settings (i.e., not primary care alone). The 'Bible' of Group Appointments is Dr. Edward Noffsinger's 500-page book Running Group Visits in Your Practice (2009). He describes two main types of GAs -not limited to the primary care setting. A second foundational source for Canadians in particular, is The Group Medical Appointment Manual (First Edition 2007) published by the Northern Health Authority in British Columbia (developed after a visit by Dr. Noffsinger).
In clinical trials, the most compelling data for Group Appointments providing superior control of HemoglobinAA1C come from Drs. Trento and Porta, University of Turin, Italy. Patients who attended structured Group Appointments decreased their HbA1C by 0.9% (Effect size 0.56) compared with control group counterparts. There are a number of differences between these studies and what the investigators propose. First, studies in Turin and around Italy took place in 'hospital-based clinics', not regular primary care settings. Second, participants in the Turin studies were 64years, on average -younger than in our proposed study. Third, Turin studies did not include a generic quality of life measure (e.g. EQ-5D) and did not estimate health utilities. Fourth, health economic implications cannot be extrapolated from the Italian to the Canadian health system.
Considering all published RCTs, HOUSDEN and DAWES (co-investigators) found a significant 0.46% reduction in HbA1C across 10 RCTs that met their inclusion criteria. However, in a 12- month US Veteran Affairs Medical Centre trial, GA patients had only a 0.3% improvement over patients randomized to individual care (effect size 0.21). Other than study duration, the approach between the US and University of Turin studies appeared similar.
The aforementioned HOUSDEN and DAWES' systematic review highlighted that no RCT in the Primary Care setting examined Group Appointments as a vehicle to improve patient management as measured by HbAIC or another clinical measure. Previous published papers describing T2DM Group Appointments in the Primary Care setting focused on patient satisfaction and physician perception.
Such research provides valuable insight into barriers and facilitators to Group Appointments. However, no studies answered the question 'Do Primary Care-led Group Appointments improve metabolic control in diabetes?' HOUSDEN reported that duration of Group Appointments (i.e., 24-months) was significantly associated with outcome (approximately 0.25% lower HbA1C per year) but number of GAs was not. That informed the decision of the investigators to conduct an RCT across two years.
The rationale for Group Appointments builds on the social cognitive theory and transtheoretical stages of change at the individual level and brings to bear group dynamics that are unavailable in an Individual Appointment. The investigators emphasize that GAs combine three elements: 1) medical care; 2) disease-specific education (e.g. the significance of HbA1C, healthy food choices); and 3) life skills development such as goal setting, action planning, and problem-solving.
Patients who attend the Group Appointments are, by definition, in the 'post-intentional' phase (transtheoretical model) when they receive education. They know their diagnosis and recognize the need to do something about it. Thus, Group Appointments move beyond mere education of medical facts and are 'dynamic' in that the curriculum will focus on key challenges that surface in the process of turning goals into action.
Collectively, these components will help patients adopt healthier lifestyles (action) and also maintain these health behavior changes when they experience setbacks or failures (coping). This is consistent with the transtheoretical model and well as the health action process approach.
Note that the Group Appointments also reinforce self-efficacy and emotional support.
This contrasts with a traditional primary care individual appointment where 1) the clinician may or may not make time for counseling in a busy schedule or 2) gives generic verbal advice or referral without attention to specific nutrition or physical activity goals that may be most appropriate for the patient. The investigators propose elements for GAs that are consistent with best evidence and patient preference.
On the one hand, Group Appointments may at first seem a logical component of the diabetes continuum of care. A proportion of primary care practices, including those of our collaborators offer them. There is Provincial Government and British Columbia (BC) Medical Association (BCMA) (through the General Practice Services Committee) endorsement. Yet there remain no quantitative metabolic (HbA1C) or economic data (QALY/health care utilization) on the outcomes of Group Appointments specifically for elderly patients with T2DM in the Canadian Primary Care setting.
Therefore, this rigorous review of the literature suggests - there is as yet NO clear Canadian evidence that would convince policymakers to invest in Primary care-led Group Appointment for older people with T2DM unless further evidence was obtained to show they work. The investigators propose to address this gap. They will conduct measurements at 0 (baseline), 12 (mid-intervention) and 24 (end of-intervention), months. The investigators assess primary outcomes at 24 months but will follow-up to evaluate change at 36 months (12-month follow-up). In addition, the investigators will obtain three-monthly data for blood tests as part of routine patient management before each of the three-monthly Group Appointments (Intervention) and at individual patient appointments (usual care). At these three-monthly intervals a research assistant (RA#1) will administer the Health Resource Utilization (HUI3) collection instrument and the EQ-5D.
SIGNIFICANCE: Despite the clinical burden of T2DM among older Canadians, and the potential for the primary care system to deliver innovative multidisciplinary care and education, there have been no randomized controlled trials (RCTs) with that goal. The "GAP" study will apply conceptual clinical innovations in Group Appointments in the primary care setting to the health need of older adults with diabetes. There is a need for quantitative Canadian research in GAs broadly and the investigators target the substantial clinical problem - diabetes in older people. Do primary care led, Group Appointments reduce HbA1C, improve quality of life and do so at a reasonable price? If the answer is encouraging, there is potential to 'scale-up' the model via divisions, provinces and ultimately nationwide.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Group Appointments, Individual Appointments (IAs)
- Keywords
- Diabetes, Older People, Seniors, Group Appointments, Group Medical Visits, Shared Appointments, Quality of Life, Physical Activity, Health care Utilization, Depression, Anxiety
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity, Patient Acceptance of Health Care, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AppointmentsBehavioural
Also called Shared Appointments, Group Medical Visits
Participants randomly assigned to the intervention group will participate in GAs of 8 patients for 1.5 hours, every 3 months for 2 years. The 3-member Care Team (MD, nurse, behaviorist) will attend each session. The nurse facilitates the session and curriculum. The MD responds to specific health questions. Patients may schedule time before or after to review their clinical results with the MD/nurse (e.g. HbAIC).
Key elements include 1) completed pre-appt questionnaires used to identify a patient's educational needs; 2) patients use goal setting and action plans to initiate and maintain healthy behaviors; 3) each class has a designated purpose and learning objectives; 4) sessional feedback, which is used to adapt the next class (3 months later) based on patient needs.
Individual Appointments (IAs)Behavioural
Participants randomly assigned to the "IAs" group will receive eight traditional 1-to-1 appointments, seeing their physician quarterly as per standard care in BC. They will be referred to ancillary services such as nutrition advice, counseling, and physical activity promotion according to 'usual care' practice. In addition, we will organize 4 1-hour social events for these participants annually. The 4 social events will be 1) a potluck lunch; 2) a movie night; 3) an event chosen by participants; and 4) a talent show. From our experience, these events enhance compliance to reporting and minimize dropouts. These events also serve to minimize 'socialization bias' that may otherwise potentially influence health measures including quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Individual Appointments (IAs) | Active comparator | Participants randomly assigned to the "IAs" group will receive eight traditional 1-to-1 appointments, seeing their physician quarterly as per standard care in BC. They will be referred to ancillary services such as nutrition advice, counseling, and physical activity promotion according to 'usual care' practice. In addition, we will organize 4 1-hour social events for these participants annually. The 4 social events will be 1) a potluck lunch; 2) a movie night; 3) an event chosen by participants; and 4) a talent show. From our experience, these events enhance compliance to reporting and minimize dropouts. These events also serve to minimize 'socialization bias' that may otherwise potentially influence health measures including quality of life. Receives: Behavioral: Individual Appointments (IAs) |
| Group Appointments (GAs) | Experimental | Participants randomly assigned to the intervention group will participate in GAs of 8 patients for 1.5 hours, every 3 months for 2 years. The 3-member Care Team (MD, nurse, behaviorist) will attend each session. The nurse facilitates the session and curriculum. The MD responds to specific health questions. Patients may schedule time before or after to review their clinical results with the MD/nurse (e.g. HbAIC).
Key elements include 1) completed pre-appt questionnaires used to identify a patient's educational needs; 2) patients use goal setting and action plans to initiate and maintain healthy behaviors; 3) each class has a designated purpose and learning objectives; 4) sessional feedback, which is used to adapt the next class (3 months later) based on patient needs. Receives: Behavioral: Group Appointments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' control (decreased levels) of HemoglobinA1C (clinical)
The investigators will measure Hemoglobin A1C (%, primary outcome), utilizing the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 24 months
Secondary outcomes (60)
Resting systolic blood pressure (mmHg)) (clinical)
The investigators will assess resting systolic blood pressure with an automated BP device BPTRU™.
Measured: Changes from baseline at 12 months
Resting systolic blood pressure (mmHg)) (clinical)
The investigators will assess resting systolic blood pressure with an automated BP device BPTRU™.
Measured: Changes from baseline at 24 months
Resting systolic blood pressure (mmHg)) (clinical)
The investigators will assess resting systolic blood pressure with an automated BP device BPTRU™.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Resting diastolic blood pressure (mmHg)) (clinical)
The investigators will assess resting diastolic blood pressure with an automated BP device BPTRU™.
Measured: Changes from baseline at 12 months
Resting diastolic blood pressure (mmHg)) (clinical)
The investigators will assess resting diastolic blood pressure with an automated BP device BPTRU™.
Measured: Changes from baseline at 24 months
Resting diastolic blood pressure (mmHg)) (clinical)
The investigators will assess resting diastolic blood pressure with an automated BP device BPTRU™.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Electrical activity of the heart (ECG) (clinical)
The investigators will assess cardiovascular disease risk factors by 12-lead ECG (10 minutes).
Measured: Changes from baseline at 12 months
Electrical activity of the heart (ECG) (clinical)
The investigators will assess cardiovascular disease risk factors by 12-lead ECG (10 minutes).
Measured: Changes from baseline at 24 months
Electrical activity of the heart (ECG) (clinical)
The investigators will assess cardiovascular disease risk factors by 12-lead ECG (10 minutes).
Measured: Changes from baseline at 36 months (1-year post-intervention)
C-reactive protein (mg/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 12 months
C-reactive protein (mg/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 24 months
C-reactive protein (mg/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 36 months (1-year post-intervention)
plasma glucose (mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 12 months
plasma glucose (mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 24 months
plasma glucose (mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 36 months (1-year post-intervention)
High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 12 months
High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 24 months
High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 12 months
Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 24 months
Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Triglycerides (mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 12 months
Triglycerides (mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 24 months
Triglycerides (mmol/L) (clinical)
The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
Height (cm): The investigators will use the wall-mounted stadiometer (Rosscraft Inc). Weight (kg): Participants remove shoes and stand on an electronic scale (Seca Model 242, Hanover, MD). For height and weight, duplicate measures are taken unless measures differ by ±0.4 cm or ±0.2 kg, when a third measure is taken. The investigators will calculate body mass index (BMI) as wt/ht2. Waist circumference (cm): The investigators use a flexible steel tape. In older adults, it is most convenient to measure at the umbilical level. The investigators obtain two measures during minimal respiration and record to the nearest 0.1 cm. They perform a third measure if the difference between the first two measures is greater than 0.2 cm. The investigators use the mean of two and the median of three measurements for analysis for all measures. Fat and muscle mass (g): The investigators will assess total body fat mass (g) and muscle mass (g) by DXA (Hologic QDR 4500W,Hologic Inc., Waltham, MA).
Measured: Changes from baseline at 12 months
Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
Height (cm): The investigators will use the wall-mounted stadiometer (Rosscraft Inc). Weight (kg): Participants remove shoes and stand on an electronic scale (Seca Model 242, Hanover, MD). For height and weight, duplicate measures are taken unless measures differ by ±0.4 cm or ±0.2 kg, when a third measure is taken. The investigators will calculate body mass index (BMI) as wt/ht2. Waist circumference (cm): The investigators use a flexible steel tape. In older adults, it is most convenient to measure at the umbilical level. The investigators obtain two measures during minimal respiration and record to the nearest 0.1 cm. They perform a third measure if the difference between the first two measures is greater than 0.2 cm. The investigators use the mean of two and the median of three measurements for analysis for all measures. Fat and muscle mass (g): The investigators will assess total body fat mass (g) and muscle mass (g) by DXA (Hologic QDR 4500W,Hologic Inc., Waltham, MA).
Measured: Changes from baseline at 24 months
Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
Height (cm): The investigators will use the wall-mounted stadiometer (Rosscraft Inc). Weight (kg): Participants remove shoes and stand on an electronic scale (Seca Model 242, Hanover, MD). For height and weight, duplicate measures are taken unless measures differ by ±0.4 cm or ±0.2 kg, when a third measure is taken. The investigators will calculate body mass index (BMI) as wt/ht2. Waist circumference (cm): The investigators use a flexible steel tape. In older adults, it is most convenient to measure at the umbilical level. The investigators obtain two measures during minimal respiration and record to the nearest 0.1 cm. They perform a third measure if the difference between the first two measures is greater than 0.2 cm. The investigators use the mean of two and the median of three measurements for analysis for all measures. Fat and muscle mass (g): The investigators will assess total body fat mass (g) and muscle mass (g) by DXA (Hologic QDR 4500W,Hologic Inc., Waltham, MA).
Measured: Changes from baseline at 36 months (1-year post-intervention)
Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
QALYs are calculated based on the quality of life of a patient (measured using health utilities) in a given health state and the time spent in that health state. The EQ-5D enables QALYs to be estimated. This captures the gains from reduced morbidity and reduced mortality by assigning quality weights at specific time points to an intervention that are based on preferences, anchored on perfect health and death, and measured on an interval scale. Economic analyses will be conducted from the BC Ministry of Health perspective and will capture the time horizon of the trial (24 months).
Measured: Changes from baseline at 12 months
Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
QALYs are calculated based on the quality of life of a patient (measured using health utilities) in a given health state and the time spent in that health state. The EQ-5D enables QALYs to be estimated. This captures the gains from reduced morbidity and reduced mortality by assigning quality weights at specific time points to an intervention that are based on preferences, anchored on perfect health and death, and measured on an interval scale. Economic analyses will be conducted from the BC Ministry of Health perspective and will capture the time horizon of the trial (24 months).
Measured: Changes from baseline at 24 months
Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
QALYs are calculated based on the quality of life of a patient (measured using health utilities) in a given health state and the time spent in that health state. The EQ-5D enables QALYs to be estimated. This captures the gains from reduced morbidity and reduced mortality by assigning quality weights at specific time points to an intervention that are based on preferences, anchored on perfect health and death, and measured on an interval scale. Economic analyses will be conducted from the BC Ministry of Health perspective and will capture the time horizon of the trial (24 months).
Measured: Changes from baseline at 36 months (1-year post-intervention)
Health Care Utilization
The investigators' economic evaluation will examine the incremental costs and benefits generated by using the Group Medical Appointments intervention versus usual care. The outcome of their cost utility analysis is the incremental cost effectiveness ratio (ICER).
By definition, an ICER is the difference between the mean costs of providing the competing interventions divided by the difference in effectiveness (i.e., QALYs), where the ICER = Δ Cost / Δ Effect. Dr. Marra will conduct a prospective economic evaluation alongside the clinical trial to 1) estimate the mean/participant and total health care resource utilization and costs associated with Group Appointments and usual care; 2) determine the QoL as measured by health state utility values; and 3) conduct a cost-utility analysis. The cost-utility analysis will be assessed in terms of incremental cost per quality adjusted life year (QALY).
Our instruments are the EQ-5D-3L and Heath Resource Utilization (HRU) questionnaires.
Measured: Changes from baseline at 12 months
Health Care Utilization
The investigators' economic evaluation will examine the incremental costs and benefits generated by using the Group Medical Appointments intervention versus usual care. The outcome of their cost utility analysis is the incremental cost effectiveness ratio (ICER).
By definition, an ICER is the difference between the mean costs of providing the competing interventions divided by the difference in effectiveness (i.e., QALYs), where the ICER = Δ Cost / Δ Effect. Dr. Marra will conduct a prospective economic evaluation alongside the clinical trial to 1) estimate the mean/participant and total health care resource utilization and costs associated with Group Appointments and usual care; 2) determine the QoL as measured by health state utility values; and 3) conduct a cost-utility analysis. The cost-utility analysis will be assessed in terms of incremental cost per quality adjusted life year (QALY).
Our instruments are the EQ-5D-3L and Heath Resource Utilization (HRU) questionnaires.
Measured: Changes from baseline at 24 months
Health Care Utilization
The investigators' economic evaluation will examine the incremental costs and benefits generated by using the Group Medical Appointments intervention versus usual care. The outcome of their cost utility analysis is the incremental cost effectiveness ratio (ICER).
By definition, an ICER is the difference between the mean costs of providing the competing interventions divided by the difference in effectiveness (i.e., QALYs), where the ICER = Δ Cost / Δ Effect. Dr. Marra will conduct a prospective economic evaluation alongside the clinical trial to 1) estimate the mean/participant and total health care resource utilization and costs associated with Group Appointments and usual care; 2) determine the QoL as measured by health state utility values; and 3) conduct a cost-utility analysis. The cost-utility analysis will be assessed in terms of incremental cost per quality adjusted life year (QALY).
Our instruments are the EQ-5D-3L and Heath Resource Utilization (HRU) questionnaires.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Anxiety
The investigators will assess anxiety with the recommended Generalized Anxiety Disorder 7-item (GAD-7) scale. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for generalised anxiety disorder. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and post-traumatic stress disorder (sensitivity 66%, specificity 81%).
The GAD-7 offer clinicians concise, self-administered screening and diagnostic tools for mental health disorders.
Measured: Changes from baseline at 12 months
Anxiety
The investigators will assess anxiety with the recommended Generalized Anxiety Disorder 7-item (GAD-7) scale. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for generalised anxiety disorder. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and post-traumatic stress disorder (sensitivity 66%, specificity 81%).
The GAD-7 offer clinicians concise, self-administered screening and diagnostic tools for mental health disorders.
Measured: Changes from baseline at 24 months
Anxiety
The investigators will assess anxiety with the recommended Generalized Anxiety Disorder 7-item (GAD-7) scale. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for generalised anxiety disorder. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and post-traumatic stress disorder (sensitivity 66%, specificity 81%).
The GAD-7 offer clinicians concise, self-administered screening and diagnostic tools for mental health disorders.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Depression
The investigators will assess depression with the recommended Geriatric Depression Scale (GDS). The GDS is a 30-item self-report assessment used to identify depression in the elderly. The scale was first developed in 1982 by J.A. Yesavage and others.
Measured: Changes from baseline at 12 months
Depression
The investigators will assess depression with the recommended Geriatric Depression Scale (GDS). The GDS is a 30-item self-report assessment used to identify depression in the elderly. The scale was first developed in 1982 by J.A. Yesavage and others.
Measured: Changes from baseline at 24 months
Depression
The investigators will assess depression with the recommended Geriatric Depression Scale (GDS). The GDS is a 30-item self-report assessment used to identify depression in the elderly. The scale was first developed in 1982 by J.A. Yesavage and others.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Satisfaction With Life Scale
The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction developed by Ed Diener and colleagues (Diener, Emmons, Larsen \& Griffin, 1985). The SWLS consists of 5-items that are completed by the individual whose life satisfaction is being measured.
Measured: Changes from baseline at 12 months
Satisfaction With Life Scale
The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction developed by Ed Diener and colleagues (Diener, Emmons, Larsen \& Griffin, 1985). The SWLS consists of 5-items that are completed by the individual whose life satisfaction is being measured.
Measured: Changes from baseline at 24 months
Satisfaction With Life Scale
The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction developed by Ed Diener and colleagues (Diener, Emmons, Larsen \& Griffin, 1985). The SWLS consists of 5-items that are completed by the individual whose life satisfaction is being measured.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Physical Activity (PASE)
The investigators will assess physical activity with the valid and reliable Physical Activities Scale for the Elderly (PASE) questionnaire. PASE was designed for those aged 65 years and older; participants use a 12-item scale to self-report the hours per day (average) spent participating in leisure, household, and occupational physical activities over the previous seven-day period. Physical activity is an important covariate in this study.
Measured: Changes from baseline at 12 months
Physical Activity (PASE)
The investigators will assess physical activity with the valid and reliable Physical Activities Scale for the Elderly (PASE) questionnaire. PASE was designed for those aged 65 years and older; participants use a 12-item scale to self-report the hours per day (average) spent participating in leisure, household, and occupational physical activities over the previous seven-day period. Physical activity is an important covariate in this study.
Measured: Changes from baseline at 24 months
Physical Activity (PASE)
The investigators will assess physical activity with the valid and reliable Physical Activities Scale for the Elderly (PASE) questionnaire. PASE was designed for those aged 65 years and older; participants use a 12-item scale to self-report the hours per day (average) spent participating in leisure, household, and occupational physical activities over the previous seven-day period. Physical activity is an important covariate in this study.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Physical Activity (SenseWear)
The investigators will assess physical activity with the valid and reliable SenseWear armband, measuring steps/per day, energy expenditure (calories), and hours of activity (METs (sedentary, moderate, vigorous, very vigorous)). Participants will wear the armband for seven consecutive days, including while sleeping.
Measured: Changes from baseline at 12 months
Physical Activity (SenseWear)
The investigators will assess physical activity with the valid and reliable SenseWear armband, measuring steps/per day, energy expenditure (calories), and hours of activity (METs (sedentary, moderate, vigorous, very vigorous)). Participants will wear the armband for seven consecutive days, including while sleeping.
Measured: Changes from baseline at 24 months
Physical Activity (SenseWear)
The investigators will assess physical activity with the valid and reliable SenseWear armband, measuring steps/per day, energy expenditure (calories), and hours of activity (METs (sedentary, moderate, vigorous, very vigorous)). Participants will wear the armband for seven consecutive days, including while sleeping.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Goal Setting and Action Planning
Behavioural principles underpinning the intervention: Assistant Professor and Canada Research Chair HOPPMANN leads the behavioural aspects of the study. From her experience in psychological aging research and everyday health behaviours she designs Group Appointments to help patients 1) set realistic health goals; 2) identify good opportunities to translate those health goals into action (action planning); and 3) proactively map out strategies that maintain health behaviours in the face of challenges (coping planning).
The investigators will utilize a psychology / goal setting questionnaire.
Measured: Baseline
Goal Setting and Action Planning
Behavioural principles underpinning the intervention: Assistant Professor and Canada Research Chair HOPPMANN leads the behavioural aspects of the study. From her experience in psychological aging research and everyday health behaviours she designs Group Appointments to help patients 1) set realistic health goals; 2) identify good opportunities to translate those health goals into action (action planning); and 3) proactively map out strategies that maintain health behaviours in the face of challenges (coping planning).
The investigators will utilize a psychology / goal setting questionnaire.
Measured: Changes from baseline at 12 months
Goal Setting and Action Planning
Behavioural principles underpinning the intervention: Assistant Professor and Canada Research Chair HOPPMANN leads the behavioural aspects of the study. From her experience in psychological aging research and everyday health behaviours she designs Group Appointments to help patients 1) set realistic health goals; 2) identify good opportunities to translate those health goals into action (action planning); and 3) proactively map out strategies that maintain health behaviours in the face of challenges (coping planning).
The investigators will utilize a psychology / goal setting questionnaire.
Measured: Changes from baseline at 24 months
Goal Setting and Action Planning
Behavioural principles underpinning the intervention: Assistant Professor and Canada Research Chair HOPPMANN leads the behavioural aspects of the study. From her experience in psychological aging research and everyday health behaviours she designs Group Appointments to help patients 1) set realistic health goals; 2) identify good opportunities to translate those health goals into action (action planning); and 3) proactively map out strategies that maintain health behaviours in the face of challenges (coping planning).
The investigators will utilize a psychology / goal setting questionnaire.
Measured: Changes from baseline at 36 months
Food Diary
Investigators will assess nutritional intake, using a three-day food diary.
Measured: Baseline
Food Diary
Investigators will assess nutritional intake, using a three-day food diary.
Measured: Changes from baseline at 12 months
Food Diary
Investigators will assess nutritional intake, using a three-day food diary.
Measured: Changes from baseline at 24 months
Food Diary
Investigators will assess nutritional intake, using a three-day food diary.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Patient Self-Management
Investigators will assess patient self-management, using the Patient Activation Measure (PAM) questionnaire. Patient self-management has been identified as a key component to the management of T2DM (CDA/ADA Practice Guidelines). Patients who have the skills, ability, and willingness to manage their own health have better health outcomes. The PAM questionnaire has been tested extensively across a number of different languages, cultures, and demographic groups, and among people with different health conditions.
Measured: Baseline
Patient Self-Management
Investigators will assess patient self-management, using the Patient Activation Measure (PAM) questionnaire. Patient self-management has been identified as a key component to the management of T2DM (CDA/ADA Practice Guidelines). Patients who have the skills, ability, and willingness to manage their own health have better health outcomes. The PAM questionnaire has been tested extensively across a number of different languages, cultures, and demographic groups, and among people with different health conditions.
Measured: Changes from baseline at 12 months
Patient Self-Management
Investigators will assess patient self-management, using the Patient Activation Measure (PAM) questionnaire. Patient self-management has been identified as a key component to the management of T2DM (CDA/ADA Practice Guidelines). Patients who have the skills, ability, and willingness to manage their own health have better health outcomes. The PAM questionnaire has been tested extensively across a number of different languages, cultures, and demographic groups, and among people with different health conditions.
Measured: Changes from baseline at 24 months
Patient Self-Management
Investigators will assess patient self-management, using the Patient Activation Measure (PAM) questionnaire. Patient self-management has been identified as a key component to the management of T2DM (CDA/ADA Practice Guidelines). Patients who have the skills, ability, and willingness to manage their own health have better health outcomes. The PAM questionnaire has been tested extensively across a number of different languages, cultures, and demographic groups, and among people with different health conditions.
Measured: Changes from baseline at 36 months (1-year post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (74)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, British Columbia
- Responsible party
- Principal investigator, Karim Miran-Khan, University of British Columbia
- Investigators
- Karim Miran-Khan, MD, PhD, MBA, Principal investigator, Centre for Hip Health and Mobility (University of British Columbia)Jennifer Davis, PhD, Study director, UBC Department of Population & Public HealthMartin Dawes, MB.BS, MD, Study director, UBC Department of Family PracticeChristiane Hoppmann, PhD, Study director, UBC Psychology DepartmentTeresa Liu-Ambrose, PhD, PT, Study director, UBC Department of Physical TherapyKen Madden, MD, Study director, UBC Department of Medicine (Geriatric Medicine)Carlo Marra, Pharm.D, PhD, Study director, UBC Faculty of Pharmaceutical SciencesAdriaan Windt, MD, Study director, UBC Department of Family Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002143
- Sponsor's protocol ID
- H13-02812
- Acronym
- GAP
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2013
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Public Health Agency of Canada. Diabetes in Canada: Facts and figures from a public health perspective 2011. Ottawa: Government of Canada, 2011.
Lysy Z, Booth GL, Shah BR, Austin PC, Luo J, Lipscombe LL. The impact of income on the incidence of diabetes: a population-based study. Diabetes Res Clin Pract. 2013 Mar;99(3):372-9. doi: 10.1016/j.diabres.2012.12.005. Epub 2013 Jan 8.
PubMed 23305902Dyck R, Karunanayake C, Pahwa P, Hagel L, Lawson J, Rennie D, Dosman J; Saskatchewan Rural Health Study Group. Prevalence, risk factors and co-morbidities of diabetes among adults in rural Saskatchewan: the influence of farm residence and agriculture-related exposures. BMC Public Health. 2013 Jan 5;13:7. doi: 10.1186/1471-2458-13-7.
PubMed 23289729Cauch-Dudek K, Victor JC, Sigmond M, Shah BR. Disparities in attendance at diabetes self-management education programs after diagnosis in Ontario, Canada: a cohort study. BMC Public Health. 2013 Jan 30;13:85. doi: 10.1186/1471-2458-13-85.
PubMed 23360373Meneilly GS. Diabetes in the elderly. Med Clin North Am. 2006 Sep;90(5):909-23. doi: 10.1016/j.mcna.2006.05.011.
PubMed 16962849Doucet G, Beatty M. The cost of diabetes in Canada: the economic Tsunami. Can J Diabetes 2010;34:27-29
Caro JJ, Getsios D, Caro I, Klittich WS, O'Brien JA. Economic evaluation of therapeutic interventions to prevent Type 2 diabetes in Canada. Diabet Med. 2004 Nov;21(11):1229-36. doi: 10.1111/j.1464-5491.2004.01330.x.
PubMed 15498090Moffatt E, Shack LG, Petz GJ, Sauve JK, Hayward K, Colman R. The cost of obesity and overweight in 2005: a case study of Alberta, Canada. Can J Public Health. 2011 Mar-Apr;102(2):144-8. doi: 10.1007/BF03404164.
PubMed 21608388Volpato S, Leveille SG, Blaum C, Fried LP, Guralnik JM. Risk factors for falls in older disabled women with diabetes: the women's health and aging study. J Gerontol A Biol Sci Med Sci. 2005 Dec;60(12):1539-45. doi: 10.1093/gerona/60.12.1539.
PubMed 16424285Crane PK, Walker R, Larson EB. Glucose levels and risk of dementia. N Engl J Med. 2013 Nov 7;369(19):1863-4. doi: 10.1056/NEJMc1311765. No abstract available.
PubMed 24195563Lam R, Gallinaro A, Adleman J. Medical Problems Referred to a Care of the Elderly Physician: Insight for Future Geriatrics CME. Can Geriatr J. 2013 Sep 4;16(3):114-9. doi: 10.5770/cgj.16.58. eCollection 2013.
PubMed 23983827Hubbard RE, Andrew MK, Fallah N, Rockwood K. Comparison of the prognostic importance of diagnosed diabetes, co-morbidity and frailty in older people. Diabet Med. 2010 May;27(5):603-6. doi: 10.1111/j.1464-5491.2010.02977.x.
PubMed 20536960Alexander GC, Sehgal NL, Moloney RM, Stafford RS. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med. 2008 Oct 27;168(19):2088-94. doi: 10.1001/archinte.168.19.2088.
PubMed 18955637Furler J, Hii JW, Liew D, Blackberry I, Best J, Segal L, Young D. The "cost" of treating to target: cross-sectional analysis of patients with poorly controlled type 2 diabetes in Australian general practice. BMC Fam Pract. 2013 Mar 8;14:32. doi: 10.1186/1471-2296-14-32.
PubMed 23510207Teoh H, Despres JP, Dufour R, Fitchett DH, Goldin L, Goodman SG, Harris SB, Langer A, Lau DC, Lonn EM, John Mancini GB, McFarlane PA, Poirier P, Rabasa-Lhoret R, Tan MK, Leiter LA. Identification and management of patients at elevated cardiometabolic risk in canadian primary care: how well are we doing? Can J Cardiol. 2013 Aug;29(8):960-8. doi: 10.1016/j.cjca.2012.12.001. Epub 2013 Mar 7.
PubMed 23465284
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Medical Visits (GMVs) in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People
- ClinicalTrials.gov ID
- NCT02002143
- Acronym / sponsor ID
- GAP / H13-02812
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Diabetes, Older People, Seniors, Group Appointments, Group Medical Visits, Shared Appointments, Quality of Life, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Ministry of Health, British Columbia
- Study start
- Jan 2014
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes is a major problem of older people; its prevalence is greater than 20% in those aged over 65 years. Treatment such as medication, healthy nutritional choices \& body weight management, as well as physical activity can reduce the impact of diabetes.
Older patients with type 2 diabetes can potentially benefit from Group Appointments, in which 8-12 patients share one appointment of about 60-120 minutes with a team of health professionals.
The team of investigators (3 people) will see the 'Group' 4 times/yr for two years. Their key measure of success will be control of glycosylated hemoglobin - HbA1C.
To address their primary and secondary research objectives the investigators will focus upon patients aged 65 years or older who have T2DM and who are being treated with oral hypoglycemic agents and diet, or diet alone.
The investigators will compare patients randomized to (A) eight Group Appointments over a 24 month period (i.e., 4 per year), led by a primary care physician [Intervention] with, (B) patients randomized to eight traditional one-to-one usual care appointments also provided by a primary care physician (Individual Appointment; [Control]). The investigators will compare (A) and (B) on selected clinical, patient-rated, and economic outcome measures.
SIGNIFICANCE: Seven Canadian provinces already have Group Appointment billing codes for physicians who lead Group Appointments. If the study's proposed health care innovation demonstrates benefits, it would be possible to 'roll out' / 'scale up' the model province- or nation-wide in Primary Care settings.
Detailed description
Type 2 diabetes mellitus (T2DM) in older people is an undisputed health problem. More than 1.1 million people diagnosed with diabetes mellitus (DM) in Canada are over the age of 65 years. Rates of T2DM in older people are accelerating even when adjusted for age. Thus, total community prevalence is increasing based on the greater number of older people, an increased rate among those older people, and improved survival rates of people with DM.
The financial burden of DM to the Canadian health care system will approach $17 billion/year by 2020. Beyond the direct health burden of T2DM, the condition is an independent risk factor for falls and dementia -two of the 'geriatric giants'. T2DM is 'an important unresolved issue previously unacknowledged' and is considered to increase 'biological age' by 2 years in those aged over 70 years.
Although treatment can improve the clinical trajectory of older people with T2DM, many do not receive guideline care. Combinations of drug treatment, physical activity, nutrition advice and body weight management, reduce risk factors, delay onset of disease and lessen the rate of complications.
Group Appointments (GAs) - also called Group Medical Visits or Shared Medical Appointments may contribute to improved T2DM care for older people in the primary care setting. The innovation in this study is to undertake research in one study to determine 1) the clinical effectiveness; 2) quality of life; and 3) economic implications of Group Appointments for older people with T2DM.
'Group Appointments' exist in various forms. Their origin is often attributed to Noffsinger and also Ward. In a Group Appointment, one physician works with a nurse and a 'behaviourist' (described on page 12c) to care for eight to twelve patients during one 60-120 minute appointment.
A recent Systematic Review of Group Appointments in T2DM performed by two current Co-Investigators (HOUSDEN, DAWES) highlighted the need for a Canadian Primary Care RCT that would extend previous research from Italy. The extension of research by this study is to have a Primary Care physician lead Group Appointments and for the RCT to include exclusively men and women aged 65 years and older.
The clinical and societal importance of T2DM in older people is not disputed. 'Diabetes mellitus is a serious condition with potentially devastating complications that affects all age groups worldwide'.
Diabetes epidemiology was reviewed in the 2013 Canadian Diabetes Practice Guidelines and Public Health Agency of Canada's 'Diabetes in Facts \& Figures'. To make this literature 'critical' the investigators will focus on 1) the accelerating rate of diagnosis of type 2 diabetes in older people; 2) the challenge of delivering quality diabetes care affordably in a traditional one-to-one primary care encounter 3) the equipoise that results from international evidence for testing GAs to improve patient self-management in the absence of Canadian Primary Care research in this field; 4) a brief review of the validity and limitations of HbA1C as a measure of T2DM self-management; and 5) the theoretical framework underpinning their Group Appointment intervention.
From the 2013 Canadian Clinical Practice Guidelines for Diabetes, as of 2009, 6.8% of Canadians (2.4 million people) had the condition. This represented a 230% increase compared to prevalence estimates 11 years earlier. A decade from now, an additional 1.3 million Canadians are expected to have T2DM. Diabetes and its complications increase costs and service pressures on Canada's publicly funded healthcare system. People with diabetes were three times more likely to require hospital admission in the preceding year with longer lengths of stay.
Good metabolic control of diabetes prevents complications. This requires lifestyle and behavioural modification. In Canada, the usual clinical care for diabetes is via individual patient consultations combined with 'ad hoc' educational advice during a family practice appointment or referral to an educational support program, if available. Although traditional primary care delivery addresses clinical problems, it fails to embrace the principles of behaviour change (compliance/ adherence) that are an essential part of chronic disease management.
The Canadian Practice Guidelines for T2DM call for psychological support, exercise promotion and nutritional advice. Traditional one-to-one clinical encounters in a fee-for-service setting do not encourage such coordinated care. There is a call to improve the scope of diabetes care currently offered in Canada. The quote 'if you keep doing what you've always done, you'll keep getting what you've always got' is relevant in this setting.
Traditional one-to-one clinical encounters will always have a place in health service delivery.
However, given the common needs across patients and the burgeoning costs to treat those with T2DM - the investigators address the question, 'Is there a more effective way to encourage successful patient self-management for older people with T2DM.
Two major resources on Group Appointments relate to various medical settings (i.e., not primary care alone). The 'Bible' of Group Appointments is Dr. Edward Noffsinger's 500-page book Running Group Visits in Your Practice (2009). He describes two main types of GAs -not limited to the primary care setting. A second foundational source for Canadians in particular, is The Group Medical Appointment Manual (First Edition 2007) published by the Northern Health Authority in British Columbia (developed after a visit by Dr. Noffsinger).
In clinical trials, the most compelling data for Group Appointments providing superior control of HemoglobinAA1C come from Drs. Trento and Porta, University of Turin, Italy. Patients who attended structured Group Appointments decreased their HbA1C by 0.9% (Effect size 0.56) compared with control group counterparts. There are a number of differences between these studies and what the investigators propose. First, studies in Turin and around Italy took place in 'hospital-based clinics', not regular primary care settings. Second, participants in the Turin studies were 64years, on average -younger than in our proposed study. Third, Turin studies did not include a generic quality of life measure (e.g. EQ-5D) and did not estimate health utilities. Fourth, health economic implications cannot be extrapolated from the Italian to the Canadian health system.
Considering all published RCTs, HOUSDEN and DAWES (co-investigators) found a significant 0.46% reduction in HbA1C across 10 RCTs that met their inclusion criteria. However, in a 12- month US Veteran Affairs Medical Centre trial, GA patients had only a 0.3% improvement over patients randomized to individual care (effect size 0.21). Other than study duration, the approach between the US and University of Turin studies appeared similar.
The aforementioned HOUSDEN and DAWES' systematic review highlighted that no RCT in the Primary Care setting examined Group Appointments as a vehicle to improve patient management as measured by HbAIC or another clinical measure. Previous published papers describing T2DM Group Appointments in the Primary Care setting focused on patient satisfaction and physician perception.
Such research provides valuable insight into barriers and facilitators to Group Appointments. However, no studies answered the question 'Do Primary Care-led Group Appointments improve metabolic control in diabetes?' HOUSDEN reported that duration of Group Appointments (i.e., 24-months) was significantly associated with outcome (approximately 0.25% lower HbA1C per year) but number of GAs was not. That informed the decision of the investigators to conduct an RCT across two years.
The rationale for Group Appointments builds on the social cognitive theory and transtheoretical stages of change at the individual level and brings to bear group dynamics that are unavailable in an Individual Appointment. The investigators emphasize that GAs combine three elements: 1) medical care; 2) disease-specific education (e.g. the significance of HbA1C, healthy food choices); and 3) life skills development such as goal setting, action planning, and problem-solving.
Patients who attend the Group Appointments are, by definition, in the 'post-intentional' phase (transtheoretical model) when they receive education. They know their diagnosis and recognize the need to do something about it. Thus, Group Appointments move beyond mere education of medical facts and are 'dynamic' in that the curriculum will focus on key challenges that surface in the process of turning goals into action.
Collectively, these components will help patients adopt healthier lifestyles (action) and also maintain these health behavior changes when they experience setbacks or failures (coping). This is consistent with the transtheoretical model and well as the health action process approach.
Note that the Group Appointments also reinforce self-efficacy and emotional support.
This contrasts with a traditional primary care individual appointment where 1) the clinician may or may not make time for counseling in a busy schedule or 2) gives generic verbal advice or referral without attention to specific nutrition or physical activity goals that may be most appropriate for the patient. The investigators propose elements for GAs that are consistent with best evidence and patient preference.
On the one hand, Group Appointments may at first seem a logical component of the diabetes continuum of care. A proportion of primary care practices, including those of our collaborators offer them. There is Provincial Government and British Columbia (BC) Medical Association (BCMA) (through the General Practice Services Committee) endorsement. Yet there remain no quantitative metabolic (HbA1C) or economic data (QALY/health care utilization) on the outcomes of Group Appointments specifically for elderly patients with T2DM in the Canadian Primary Care setting.
Therefore, this rigorous review of the literature suggests - there is as yet NO clear Canadian evidence that would convince policymakers to invest in Primary care-led Group Appointment for older people with T2DM unless further evidence was obtained to show they work. The investigators propose to address this gap. They will conduct measurements at 0 (baseline), 12 (mid-intervention) and 24 (end of-intervention), months. The investigators assess primary outcomes at 24 months but will follow-up to evaluate change at 36 months (12-month follow-up). In addition, the investigators will obtain three-monthly data for blood tests as part of routine patient management before each of the three-monthly Group Appointments (Intervention) and at individual patient appointments (usual care). At these three-monthly intervals a research assistant (RA#1) will administer the Health Resource Utilization (HUI3) collection instrument and the EQ-5D.
SIGNIFICANCE: Despite the clinical burden of T2DM among older Canadians, and the potential for the primary care system to deliver innovative multidisciplinary care and education, there have been no randomized controlled trials (RCTs) with that goal. The "GAP" study will apply conceptual clinical innovations in Group Appointments in the primary care setting to the health need of older adults with diabetes. There is a need for quantitative Canadian research in GAs broadly and the investigators target the substantial clinical problem - diabetes in older people. Do primary care led, Group Appointments reduce HbA1C, improve quality of life and do so at a reasonable price? If the answer is encouraging, there is potential to 'scale-up' the model via divisions, provinces and ultimately nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Appointments (IAs) | Active comparator | Behavioral: Individual Appointments (IAs)Participants randomly assigned to the "IAs" group will receive eight traditional 1-to-1 appointments, seeing their physician quarterly as per standard care in BC. They will be referred to ancillary services such as nutrition advice, counseling, and physical activity promotion according to 'usual care' practice. In addition, we will organize 4 1-hour social events for these participants annually. The 4 social events will be 1) a potluck lunch; 2) a movie night; 3) an event chosen by participants; and 4) a talent show. From our experience, these events enhance compliance to reporting and minimize dropouts. These events also serve to minimize 'socialization bias' that may otherwise potentially influence health measures including quality of life. |
| Group Appointments (GAs) | Experimental | Behavioral: Group AppointmentsParticipants randomly assigned to the intervention group will participate in GAs of 8 patients for 1.5 hours, every 3 months for 2 years. The 3-member Care Team (MD, nurse, behaviorist) will attend each session. The nurse facilitates the session and curriculum. The MD responds to specific health questions. Patients may schedule time before or after to review their clinical results with the MD/nurse (e.g. HbAIC). Key elements include 1) completed pre-appt questionnaires used to identify a patient's educational needs; 2) patients use goal setting and action plans to initiate and maintain healthy behaviors; 3) each class has a designated purpose and learning objectives; 4) sessional feedback, which is used to adapt the next class (3 months later) based on patient needs. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- aged ≥ 65 years old;
- have at least a 12-month history of T2DM based on the Canadian Diabetes Guidelines;
- be community-dwelling;
- live within 30km of their GP clinic in Abbotsford, BC (Canada);
- able to comply with scheduled visits, treatment plan, and other trial procedures;
Key exclusion criteria (6 listed)
- using insulin to treat diabetes to increase the homogeneity of the sample;
- at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
- Mini-Mental State Examination (MMSE)[51] score of ≤ 24 at screening;
- have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
- taking medications that may negatively affect the ability to undertake a simple walking program safely (e.g. beta blockers);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AppointmentsAlso: Shared Appointments, Group Medical VisitsParticipants randomly assigned to the intervention group will participate in GAs of 8 patients for 1.5 hours, every 3 months for 2 years. The 3-member Care Team (MD, nurse, behaviorist) will attend each session. The nurse facilitates the session and curriculum. The MD responds to specific health questions. Patients may schedule time before or after to review their clinical results with the MD/nurse (e.g. HbAIC). Key elements include 1) completed pre-appt questionnaires used to identify a patient's educational needs; 2) patients use goal setting and action plans to initiate and maintain healthy behaviors; 3) each class has a designated purpose and learning objectives; 4) sessional feedback, which is used to adapt the next class (3 months later) based on patient needs. | Behavioural | Group Appointments (GAs) |
| Individual Appointments (IAs)Participants randomly assigned to the "IAs" group will receive eight traditional 1-to-1 appointments, seeing their physician quarterly as per standard care in BC. They will be referred to ancillary services such as nutrition advice, counseling, and physical activity promotion according to 'usual care' practice. In addition, we will organize 4 1-hour social events for these participants annually. The 4 social events will be 1) a potluck lunch; 2) a movie night; 3) an event chosen by participants; and 4) a talent show. From our experience, these events enhance compliance to reporting and minimize dropouts. These events also serve to minimize 'socialization bias' that may otherwise potentially influence health measures including quality of life. | Behavioural | Individual Appointments (IAs) |
Primary outcome
Patients' control (decreased levels) of HemoglobinA1C (clinical)
Time frame: Changes from baseline at 24 months
The investigators will measure Hemoglobin A1C (%, primary outcome), utilizing the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.
60 secondary outcomes
Resting systolic blood pressure (mmHg)) (clinical)
Time frame: Changes from baseline at 12 months
Resting systolic blood pressure (mmHg)) (clinical)
Time frame: Changes from baseline at 24 months
Resting systolic blood pressure (mmHg)) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Resting diastolic blood pressure (mmHg)) (clinical)
Time frame: Changes from baseline at 12 months
Resting diastolic blood pressure (mmHg)) (clinical)
Time frame: Changes from baseline at 24 months
Resting diastolic blood pressure (mmHg)) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Electrical activity of the heart (ECG) (clinical)
Time frame: Changes from baseline at 12 months
Electrical activity of the heart (ECG) (clinical)
Time frame: Changes from baseline at 24 months
Electrical activity of the heart (ECG) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
C-reactive protein (mg/L) (clinical)
Time frame: Changes from baseline at 12 months
C-reactive protein (mg/L) (clinical)
Time frame: Changes from baseline at 24 months
C-reactive protein (mg/L) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
plasma glucose (mmol/L) (clinical)
Time frame: Changes from baseline at 12 months
plasma glucose (mmol/L) (clinical)
Time frame: Changes from baseline at 24 months
plasma glucose (mmol/L) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
Time frame: Changes from baseline at 12 months
High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
Time frame: Changes from baseline at 24 months
High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
Time frame: Changes from baseline at 12 months
Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
Time frame: Changes from baseline at 24 months
Fasting low-density lipoprotein (LDL; mmol/L) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Triglycerides (mmol/L) (clinical)
Time frame: Changes from baseline at 12 months
Triglycerides (mmol/L) (clinical)
Time frame: Changes from baseline at 24 months
Triglycerides (mmol/L) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
Time frame: Changes from baseline at 12 months
Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
Time frame: Changes from baseline at 24 months
Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical)
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
Time frame: Changes from baseline at 12 months
Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
Time frame: Changes from baseline at 24 months
Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic))
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Health Care Utilization
Time frame: Changes from baseline at 12 months
Health Care Utilization
Time frame: Changes from baseline at 24 months
Health Care Utilization
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Anxiety
Time frame: Changes from baseline at 12 months
Anxiety
Time frame: Changes from baseline at 24 months
Anxiety
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Depression
Time frame: Changes from baseline at 12 months
Depression
Time frame: Changes from baseline at 24 months
Depression
Time frame: Changes from baseline at 36 months (1-year post-intervention)
Satisfaction With Life Scale
Time frame: Changes from baseline at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- BackgroundPublic Health Agency of Canada. Diabetes in Canada: Facts and figures from a public health perspective 2011. Ottawa: Government of Canada, 2011.
- Background: PubMed 23305902Lysy Z, Booth GL, Shah BR, Austin PC, Luo J, Lipscombe LL. The impact of income on the incidence of diabetes: a population-based study. Diabetes Res Clin Pract. 2013 Mar;99(3):372-9. doi: 10.1016/j.diabres.2012.12.005. Epub 2013 Jan 8.
- Background: PubMed 23289729Dyck R, Karunanayake C, Pahwa P, Hagel L, Lawson J, Rennie D, Dosman J; Saskatchewan Rural Health Study Group. Prevalence, risk factors and co-morbidities of diabetes among adults in rural Saskatchewan: the influence of farm residence and agriculture-related exposures. BMC Public Health. 2013 Jan 5;13:7. doi: 10.1186/1471-2458-13-7.
- Background: PubMed 23360373Cauch-Dudek K, Victor JC, Sigmond M, Shah BR. Disparities in attendance at diabetes self-management education programs after diagnosis in Ontario, Canada: a cohort study. BMC Public Health. 2013 Jan 30;13:85. doi: 10.1186/1471-2458-13-85.
- Background: PubMed 16962849Meneilly GS. Diabetes in the elderly. Med Clin North Am. 2006 Sep;90(5):909-23. doi: 10.1016/j.mcna.2006.05.011.
- BackgroundDoucet G, Beatty M. The cost of diabetes in Canada: the economic Tsunami. Can J Diabetes 2010;34:27-29
- Background: PubMed 15498090Caro JJ, Getsios D, Caro I, Klittich WS, O'Brien JA. Economic evaluation of therapeutic interventions to prevent Type 2 diabetes in Canada. Diabet Med. 2004 Nov;21(11):1229-36. doi: 10.1111/j.1464-5491.2004.01330.x.
- Background: PubMed 21608388Moffatt E, Shack LG, Petz GJ, Sauve JK, Hayward K, Colman R. The cost of obesity and overweight in 2005: a case study of Alberta, Canada. Can J Public Health. 2011 Mar-Apr;102(2):144-8. doi: 10.1007/BF03404164.
- Background: PubMed 16424285Volpato S, Leveille SG, Blaum C, Fried LP, Guralnik JM. Risk factors for falls in older disabled women with diabetes: the women's health and aging study. J Gerontol A Biol Sci Med Sci. 2005 Dec;60(12):1539-45. doi: 10.1093/gerona/60.12.1539.
- Background: PubMed 24195563Crane PK, Walker R, Larson EB. Glucose levels and risk of dementia. N Engl J Med. 2013 Nov 7;369(19):1863-4. doi: 10.1056/NEJMc1311765. No abstract available.
- Background: PubMed 23983827Lam R, Gallinaro A, Adleman J. Medical Problems Referred to a Care of the Elderly Physician: Insight for Future Geriatrics CME. Can Geriatr J. 2013 Sep 4;16(3):114-9. doi: 10.5770/cgj.16.58. eCollection 2013.
- Background: PubMed 20536960Hubbard RE, Andrew MK, Fallah N, Rockwood K. Comparison of the prognostic importance of diagnosed diabetes, co-morbidity and frailty in older people. Diabet Med. 2010 May;27(5):603-6. doi: 10.1111/j.1464-5491.2010.02977.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Miran-Khan, MD, PhD, MBA principal investigator
Centre for Hip Health and Mobility (University of British Columbia)
Jennifer Davis, PhD study director
UBC Department of Population & Public Health
Martin Dawes, MB.BS, MD study director
UBC Department of Family Practice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Appointments and Individual Appointments (IAs) in people with Type 2 Diabetes Mellitus (T2DM), run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriaan Windt, MD (604-859-9084, adriaan.windt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' control (decreased levels) of HemoglobinA1C (clinical) (time frame: Changes from baseline at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02002143, which also lists 74 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.