Diabetes Mellitus, Type 2NCT00789282
Improving the Care of Diabetic Patients: A Randomized Trial of a Family Physician Office-Based Chronic Disease Care Model for Patients With Type 2 Diabetes
A study testing multidisciplinary approach, multifactorial approach - for enhanced care group and reflects current patterns of care in people with Diabetes Mellitus, Type 2, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of the study is to determine the efficacy of a family physician practice-based model of chronic disease management (CDM) based in Primary Care Networks (PCN's) that is integrated with the Capital Health Regional Diabetes Program for care of patients with type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- multidisciplinary approach, multifactorial approach - for enhanced care group and reflects current patterns of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Dec 2011
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes (2003 classification by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus) receiving any therapy with HbA1c of > or = 7.0% between the ages of 40 - 75 years.
Who cannot join
- Type 1 diabetes
- Pregnancy
- Severe diabetic complications that include end stage renal disease requiring dialysis
- Proliferative retinopathy (growth of new vessels on the retina and posterior surface of the vitreous that requires laser therapy)
- Uncontrolled cardiovascular disease (CVS event within 1 year of enrollment)
- Psychiatric disease or cognitive impairment that would interfere with treatment compliance
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- Cancer or terminally ill patients with less than 6 months life expectancy
- Blindness
- Other severe co- morbid diseases
- Participation in another intense multifactorial intervention for the management of type 2 diabetes
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta, Dept of Family Medicicne
Edmonton, Alberta, T6G - 2C8
About this study
Official title: Single-blinded, Two-arm, Randomized Clinical Trial of Patients With Type 2 Diabetes Mellitus That Will Compare'Usual Care' With an 'Enhanced Care' Model of Chronic Disease Management That is Based in the Practices of Family Physicians Participating in Primary Care Networks (PCN's).
The purpose of the study is to determine the efficacy of a family physician practice-based model of chronic disease management (CDM) based in Primary Care Networks (PCN's) that is integrated with the Capital Health Regional Diabetes Program for care of patients with type 2 Diabetes Mellitus.
Read the detailed description
This is a single-blinded, two-arm, randomized clinical trial of patients with type 2 diabetes mellitus that will compare 'usual care' with an 'enhanced care' model of chronic disease management that is based in the practices of family physicians participating in Primary Care Networks (PCN's).
In this study, patients will be randomized into:
- Usual care (control) Will reflect current patterns of care for patients with type 2 diabetes in the Capital Health region.
- Enhanced Care (intervention) Will receive a multifactorial intervention with three main components that include:
- optimized medical management,
- support for development of enhanced patient self care management skills, and
- organized proactive follow-up by chronic disease management (CDM) teams to support improvements in care.
These components are key elements of the Chronic Care Model. They will be delivered by CDM teams working in the practices family physicians in the Primary Care Networks (PCN's).
Clinical Outcome Measures
- will be assessed at baseline, 3 months, and 6 months.
Quality of Life Measures
- will be measured at baseline, 6 months, and 12 months.
Risks and Benefits
The prevalence of diabetes mellitus is high and expected to increase in the future. It is unlikely that current systems of care will be adequate to provide care to patients with diabetes in the future. This study will evaluate a model of care of care , based on the Chronic Care Model, which has been provided to improve the care of patients with chronic diseases like diabetes. Patients may benefit due to improved care for their diabetes. Health care providers may benefit through an increased understanding of best methods and organization to provide care to populations of patients with diabetes and other chronic diseases.
Privacy and Confidentiality:
All study data collected will be kept confidential. Respondents will not be identified by name in any presentation or publications arising from the study. Access to data is restricted to investigators and project staff.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- multidisciplinary approach, multifactorial approach - for enhanced care group, reflects current patterns of care
- Keywords
- chronic disease, Family Physician, primary care network, practice-based model, type 2 diabetes, complications, sequelae
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary approachOther
Provides an integrated, proactive approach to the management of patients with chronic diseases (ie: diabetes and sequelae) Wagner Model- care encompassed in 3 overlapping galaxies: wider community; the health care system; and the provider organization. There are 6 essential elements: community resources and policies; health care organization; patient self-management support; delivery system design; decision support; and clinical information systems.
multifactorial approach - for enhanced care groupOther
optimized medical management support for development of enhanced patient self management skills organized proactive follow-up chronic disease management teams
reflects current patterns of careOther
Continue under the care of their family physician and specialists with referral to diabetic assessment and treatment centers at the discretion of the patient and physician.
Normal manner of care: could attend diabetic self education classes and consultations regarding management of diabetes. Or, participate in other patient self management program of their choice.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | The 'usual care' study arm (control) will reflect current patterns of care for patients with thpe 2 diabetes in the Capital Health region Receives: Other: reflects current patterns of care |
| Enhanced Care Group | Experimental | In the enhanced care group(intervention arm) the participants will receive a multifactorial intervention with three main components that include: optimized medical management, 2) support for development of enhanced patient self management skills, and 3) organized proactive follow-up by chronic disease management teams to support improvement in care. Receives: Other: multidisciplinary approach; Other: multifactorial approach - for enhanced care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A higher proportion of patients with type 2 diabetes enrolled in the 'enhanced care' arm compared with the patients enrolled 'usual' care' arm will achieve an absolute reduction in their HbaA1c of 1.0% or greater during the study period.
Measured: 1 year
Secondary outcomes (1)
A higher proportion of patients with type 2 diabetes in the 'enhanced care' arm compared with the patients enrolled in 'usual care' arm will achieve a 10% or greater reduction in HbA1c values during the study period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionDec 2011
Why it stopped: Recruitment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research
- Responsible party
- Sponsor
- Investigators
- Neil Bell, MD,MSc,CCFP,FCFP, Principal investigator, Professor, Dept of Family Medicine, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789282
- Sponsor's protocol ID
- 200500865
- Other IDs
- UofA grant #: 20070388
- Status last verified
- Apr 2016
- First submitted
- 12 May 2008
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blinded, Two-arm, Randomized Clinical Trial of Patients With Type 2 Diabetes Mellitus That Will Compare'Usual Care' With an 'Enhanced Care' Model of Chronic Disease Management That is Based in the Practices of Family Physicians Participating in Primary Care Networks (PCN's).
- ClinicalTrials.gov ID
- NCT00789282
- Acronym / sponsor ID
- 200500865
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- chronic disease, Family Physician, primary care network, practice-based model, type 2 diabetes, complications, sequelae
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Nov 2008 (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.
The purpose of the study is to determine the efficacy of a family physician practice-based model of chronic disease management (CDM) based in Primary Care Networks (PCN's) that is integrated with the Capital Health Regional Diabetes Program for care of patients with type 2 Diabetes Mellitus.
Detailed description
This is a single-blinded, two-arm, randomized clinical trial of patients with type 2 diabetes mellitus that will compare 'usual care' with an 'enhanced care' model of chronic disease management that is based in the practices of family physicians participating in Primary Care Networks (PCN's).
In this study, patients will be randomized into:
- Usual care (control) Will reflect current patterns of care for patients with type 2 diabetes in the Capital Health region.
- Enhanced Care (intervention) Will receive a multifactorial intervention with three main components that include:
- optimized medical management,
- support for development of enhanced patient self care management skills, and
- organized proactive follow-up by chronic disease management (CDM) teams to support improvements in care.
These components are key elements of the Chronic Care Model. They will be delivered by CDM teams working in the practices family physicians in the Primary Care Networks (PCN's).
Clinical Outcome Measures
- will be assessed at baseline, 3 months, and 6 months.
Quality of Life Measures
- will be measured at baseline, 6 months, and 12 months.
Risks and Benefits
The prevalence of diabetes mellitus is high and expected to increase in the future. It is unlikely that current systems of care will be adequate to provide care to patients with diabetes in the future. This study will evaluate a model of care of care , based on the Chronic Care Model, which has been provided to improve the care of patients with chronic diseases like diabetes. Patients may benefit due to improved care for their diabetes. Health care providers may benefit through an increased understanding of best methods and organization to provide care to populations of patients with diabetes and other chronic diseases.
Privacy and Confidentiality:
All study data collected will be kept confidential. Respondents will not be identified by name in any presentation or publications arising from the study. Access to data is restricted to investigators and project staff.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Other: reflects current patterns of careThe 'usual care' study arm (control) will reflect current patterns of care for patients with thpe 2 diabetes in the Capital Health region |
| Enhanced Care Group | Experimental | Other: multidisciplinary approach, Other: multifactorial approach - for enhanced care groupIn the enhanced care group(intervention arm) the participants will receive a multifactorial intervention with three main components that include: optimized medical management, 2) support for development of enhanced patient self management skills, and 3) organized proactive follow-up by chronic disease management teams to support improvement in care. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes (2003 classification by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus) receiving any therapy with HbA1c of > or = 7.0% between the ages of 40 - 75 years.
Key exclusion criteria (11 listed)
- Type 1 diabetes
- Pregnancy
- Severe diabetic complications that include end stage renal disease requiring dialysis
- Proliferative retinopathy (growth of new vessels on the retina and posterior surface of the vitreous that requires laser therapy)
- Uncontrolled cardiovascular disease (CVS event within 1 year of enrollment)
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 |
|---|---|---|
| multidisciplinary approachProvides an integrated, proactive approach to the management of patients with chronic diseases (ie: diabetes and sequelae) Wagner Model- care encompassed in 3 overlapping galaxies: wider community; the health care system; and the provider organization. There are 6 essential elements: community resources and policies; health care organization; patient self-management support; delivery system design; decision support; and clinical information systems. | Other | Enhanced Care Group |
| multifactorial approach - for enhanced care groupoptimized medical management support for development of enhanced patient self management skills organized proactive follow-up chronic disease management teams | Other | Enhanced Care Group |
| reflects current patterns of careContinue under the care of their family physician and specialists with referral to diabetic assessment and treatment centers at the discretion of the patient and physician. Normal manner of care: could attend diabetic self education classes and consultations regarding management of diabetes. Or, participate in other patient self management program of their choice. | Other | Usual Care Group |
Primary outcome
A higher proportion of patients with type 2 diabetes enrolled in the 'enhanced care' arm compared with the patients enrolled 'usual' care' arm will achieve an absolute reduction in their HbaA1c of 1.0% or greater during the study period.
Time frame: 1 year
1 secondary outcome
A higher proportion of patients with type 2 diabetes in the 'enhanced care' arm compared with the patients enrolled in 'usual care' arm will achieve a 10% or greater reduction in HbA1c values during the study period.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Recruitment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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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.
Neil Bell, MD,MSc,CCFP,FCFP principal investigator
Professor, Dept of Family Medicine, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary approach, multifactorial approach - for enhanced care group and reflects current patterns of care in people with Diabetes Mellitus, Type 2, run by University of Alberta at 1 site 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 1 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Recruitment challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A higher proportion of patients with type 2 diabetes enrolled in the 'enhanced care' arm compared with the patients enrolled 'usual' care' arm will achieve an absolute reduction in their HbaA1c of 1.0% or greater during the study period. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2017.