DiabetesNCT01307137
Peer-led and Telehealth Comparative Effectiveness Research (CER) Adoption for Diabetes Prevention and Management
A study testing Peer-led intervention and Telehealth Intervention in people with Diabetes and Pre-diabetes, run by South Florida Veterans Affairs Foundation for Research and Education at 2 sites in United States.
Trial summary
The prevalence of obesity and diabetes in older adults is increasing. Because older adults are often portrayed as less likely to change long-standing health behaviors, health promotion in this age group has lagged behind others. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes, Pre-diabetes
- What is being tested?
- Peer-led intervention and Telehealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Sep 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years and older
- Enrolled in HARC program
- Body mass index (BMI) ≥ 25 kg/m²
- Diagnosed diabetes or prediabetes [ADA 2003 criteria] HbA1c ≥ 5.7%
- Able to operate a telemedicine device, respond to text queries, and use his/her glucose meter, a blood pressure monitor, and a scale for daily weights
Who cannot join
- End-stage illness
- Anticipated survival less than 12 months
- Imminent nursing home placement
- Diagnosis of psychosis or significant cognitive impairment/dementia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Miami VAMC
Miami, Florida, 33125
Lisset Oropesa, MD, MS, 305-794-2669, lisset.oropesa@va.gov
Hermes J Florez, MD, MPH, PhD
University of Miami
Miami, Florida, 33125
About this study
Official title: Peer-lead and Telemedicine Activated Care (PACT) in Diabetes Prevention and Management
The prevalence of obesity and diabetes in older adults is increasing. Because older adults are often portrayed as less likely to change long-standing health behaviors, health promotion in this age group has lagged behind others. In fact, little attention has been given to the importance of diabetes prevention in community-dwelling older adults through the implementation of programs that promote healthy nutrition, increase physical activity and improve self-management. The Diabetes Prevention Program (DPP), which demonstrated the benefit of modest weight loss on the reduction of diabetes risk (58% overall reduction with a 71% reduction in the older population), has yet to be translated into widespread public health practice.
The overall objective of this protocol is to implement evidence-informed, innovative interventions to increase adoption of findings from comparative effectiveness research (CER) for diabetes management and prevention in South Florida older veterans. Specifically, the proposed study will test the hypothesis that Peer-led Care alone (PC), or activated by technology (TechnAlert-Peer or TAP), is superior to traditional methods of information dissemination (Usual Care or UC) for adoption of CER on prevention and management of diabetes, leading to better self-efficacy and clinical outcomes.
Read more
The investigators will conduct a 12-month randomized controlled trial in older veterans with prediabetes and diabetes participating in one of the Healthy Aging Regional Collaborative programs. Primary outcomes include changes in self-efficacy, weight, and hemoglobin A1c. Secondary outcomes include changes in blood pressure, lipids, physical function, quality of life, and health care utilization and the evaluation of potential racial/ethnic disparities in the process of adoption of CER for prevention and management of diabetes.
This study is expected to accelerate the implementation of CER evidence for diabetes prevention, addressing health and economic challenges in the care of overweight and obese veterans.
Read the detailed description
The prevalence of obesity and diabetes in older adults has increased during the past 20 years and will increasingly affect medical and social services, as well as costs over time. Because older adults are often portrayed as less likely to change long-standing health behaviors, health promotion in this age group has lagged behind others. In fact, little attention has been given to the importance of diabetes prevention and management in community-dwelling older adults.
A recent report of obesity diagnosis and care practice in the Veterans Health Administration showed that elderly patients were less likely to receive obesity-related education or counseling [Noel 2010]. Intentional weight loss in obese older adults has not been widely advocated by health care providers due to the perceived uncertainty of whether the benefits outweigh the risks. There is also a need to overcome the barriers to provide appropriate interventions on blood pressure, glucose, and lipid management tailored to the functionality of older adults.
The Diabetes Prevention Program (DPP) demonstrated the benefit of modest weight loss, through diet and exercise, on the reduction of diabetes risk in participants from all race/ethnic groups (58% overall reduction with a 71% reduction in the older population), leading to a delay of 4 years over a 10-year period in the onset of diabetes among those that received lifestyle intervention [DPP 2002, DPP 2009]. The DPP is considered a landmark study in comparative effectiveness research (CER), but it has yet to be translated into widespread public health practice.
South Florida provides a unique setting to accelerate the adoption of this CER evidence into practice and address the obesity and diabetes challenges of the aging population. There are more than 800,000 multi-ethnic residents age 60 and over, many of whom have one or more chronic diseases [CDC 2008]. A large number of older veterans with or at high-risk of diabetes currently receive care in the Miami VA Healthcare System.
Compelling scientific evidence exists that lifestyle change delays the onset of type 2 diabetes in high-risk persons. Lifestyle intervention can also lead to a reduction in cardiovascular risk factors in individuals with type 2 diabetes [Look AHEAD research group 2007]. However, few older adults succeed in achieving intentional weight loss through healthy diet and increased physical activity. Furthermore, some have argued that the current US health system is not prepared to deliver lifestyle interventions [Narayan 2004].
Several issues related to integration of lifestyle intervention in clinical practice have been raised. Currently, it is unknown whether other practicing professionals could deliver interventions in the community with efficacy similar to that of the interventionists of the DPP, who were trained in counseling on nutrition, exercise, and behavior modification. The investigators propose the use of telemedicine with applications in an interactive web-based system. This will allow participants to get just-in-time feedback from peers using targeted information on specific areas that need reinforcement to adopt healthy lifestyle and better self-management skills by older veterans. This will bolster the peer-participant interaction and make them more focused around areas where there are adoption gaps. This technology functions as a platform for social interaction that will lead to increase self-efficacy and better health outcomes.
The VA National Center for Health Promotion and Disease Prevention (NCP) developed the MOVE! weight management program based on the 1998/2000 Identification and Treatment of Overweight and Obesity in Adults Evidence Report. A major goal for the MOVE! program has been to reduce the prevalence of diabetes in veterans. Our long-term goal is to reduce the burden of obesity-related chronic diseases and promote healthy aging in older veterans through the implementation of best practices for prevention. The main objective of this project is to implement evidence-informed, innovative interventions to increase adoption of findings from comparative effectiveness research (CER) for diabetes management prevention in South Florida older veterans.
- Conditions
- Diabetes, Pre-diabetes
- Being tested
- Peer-led intervention, Telehealth Intervention
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led interventionBehavioural
Also called PC
An expert patient in the peer-led intervention will provide effective support for patients and families to accelerate adoption of CER for diabetes prevention and management in the elderly. This will lead to better self-efficacy and clinical outcomes.
Those veterans enrolled in the MOVE! and HARC programs that have showed success in management of weight and Diabetes will be offered to become peer-leaders.
- Weight management success is defined as a loss of at least 5% of the weight since enrollment
- Diabetes management will be defined as adequate control of HbA1c and/ or blood pressure and lipids.
The potentials peer-leaders will have a pre-assessment test to evaluate diabetes prevention and management knowledge and motivation and support skills.
Telehealth InterventionBehavioural
Also called TAP
Participants in the TAP group will receive mobile phones that will be programmed to monitor specific clinical parameters and promote adoption of CER on prevention and management of diabetes, with protocols developed in part based on the input from the focus groups. These devices display messages, tips, reminders and questions regarding healthy lifestyle and clinical parameters of diabetes, which will be developed using best practice guidelines. Participants will be asked to respond to the questions daily if they can. Also they are asked to provide their daily weight, blood pressure, and glucose levels (the later only for patients with diabetes).
| Study group | Role | What they receive |
|---|---|---|
| Telehealth (TAP) | Experimental | Not described Receives: Behavioral: Telehealth Intervention |
| Peer-led care (PC) | Experimental | Not described Receives: Behavioral: Peer-led intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare changes in self-efficacy between participants receiving peer-led care (with or without TAP intervention) and those receiving UC over 12 months.
Measured: 12 months
Compare changes in weight and hemoglobin A1c between participants receiving peer-led care (with or without TAP intervention) and those receiving UC over 12 months.
Measured: 12 months
Secondary outcomes (3)
Compare changes in weight, hemoglobin A1c, and self-efficacy between white-non-hispanics and minorities over 12 months.
Measure changes in blood pressure, lipids, physical function, quality of life, health care utilization (physician visits, emergency visits, and days in hospital) among racial minorities compared to non-minorities.
Measured: 12 months
Compare changes in blood pressure, lipids, physical function, and quality of life among treatment groups (UC, PC, and TAP).
Measured: 12 months
Compare changes in health care utilization (physician visits, emergency visits, and days in hospital) among treatment groups (UC, PC, and TAP).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Florida Veterans Affairs Foundation for Research and Education
- Sponsor type
- US federal agency
- Investigators
- Lisset Oropesa, MD, Study director, Miami VAMCHermes J Florez, MD, Principal investigator, Miami VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307137
- Sponsor's protocol ID
- 00915
- Status last verified
- Jan 2011
- First submitted
- 1 Mar 2011
- Last updated
- 2 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-lead and Telemedicine Activated Care (PACT) in Diabetes Prevention and Management
- ClinicalTrials.gov ID
- NCT01307137
- Acronym / sponsor ID
- 00915
- Conditions
- Diabetes, Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- South Florida Veterans Affairs Foundation for Research and EducationUS federal agency
- Study start
- Jun 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 2 Mar 2011 (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 prevalence of obesity and diabetes in older adults is increasing. Because older adults are often portrayed as less likely to change long-standing health behaviors, health promotion in this age group has lagged behind others. In fact, little attention has been given to the importance of diabetes prevention in community-dwelling older adults through the implementation of programs that promote healthy nutrition, increase physical activity and improve self-management. The Diabetes Prevention Program (DPP), which demonstrated the benefit of modest weight loss on the reduction of diabetes risk (58% overall reduction with a 71% reduction in the older population), has yet to be translated into widespread public health practice.
The overall objective of this protocol is to implement evidence-informed, innovative interventions to increase adoption of findings from comparative effectiveness research (CER) for diabetes management and prevention in South Florida older veterans. Specifically, the proposed study will test the hypothesis that Peer-led Care alone (PC), or activated by technology (TechnAlert-Peer or TAP), is superior to traditional methods of information dissemination (Usual Care or UC) for adoption of CER on prevention and management of diabetes, leading to better self-efficacy and clinical outcomes.
The investigators will conduct a 12-month randomized controlled trial in older veterans with prediabetes and diabetes participating in one of the Healthy Aging Regional Collaborative programs. Primary outcomes include changes in self-efficacy, weight, and hemoglobin A1c. Secondary outcomes include changes in blood pressure, lipids, physical function, quality of life, and health care utilization and the evaluation of potential racial/ethnic disparities in the process of adoption of CER for prevention and management of diabetes.
This study is expected to accelerate the implementation of CER evidence for diabetes prevention, addressing health and economic challenges in the care of overweight and obese veterans.
Detailed description
The prevalence of obesity and diabetes in older adults has increased during the past 20 years and will increasingly affect medical and social services, as well as costs over time. Because older adults are often portrayed as less likely to change long-standing health behaviors, health promotion in this age group has lagged behind others. In fact, little attention has been given to the importance of diabetes prevention and management in community-dwelling older adults.
A recent report of obesity diagnosis and care practice in the Veterans Health Administration showed that elderly patients were less likely to receive obesity-related education or counseling [Noel 2010]. Intentional weight loss in obese older adults has not been widely advocated by health care providers due to the perceived uncertainty of whether the benefits outweigh the risks. There is also a need to overcome the barriers to provide appropriate interventions on blood pressure, glucose, and lipid management tailored to the functionality of older adults.
The Diabetes Prevention Program (DPP) demonstrated the benefit of modest weight loss, through diet and exercise, on the reduction of diabetes risk in participants from all race/ethnic groups (58% overall reduction with a 71% reduction in the older population), leading to a delay of 4 years over a 10-year period in the onset of diabetes among those that received lifestyle intervention [DPP 2002, DPP 2009]. The DPP is considered a landmark study in comparative effectiveness research (CER), but it has yet to be translated into widespread public health practice.
South Florida provides a unique setting to accelerate the adoption of this CER evidence into practice and address the obesity and diabetes challenges of the aging population. There are more than 800,000 multi-ethnic residents age 60 and over, many of whom have one or more chronic diseases [CDC 2008]. A large number of older veterans with or at high-risk of diabetes currently receive care in the Miami VA Healthcare System.
Compelling scientific evidence exists that lifestyle change delays the onset of type 2 diabetes in high-risk persons. Lifestyle intervention can also lead to a reduction in cardiovascular risk factors in individuals with type 2 diabetes [Look AHEAD research group 2007]. However, few older adults succeed in achieving intentional weight loss through healthy diet and increased physical activity. Furthermore, some have argued that the current US health system is not prepared to deliver lifestyle interventions [Narayan 2004].
Several issues related to integration of lifestyle intervention in clinical practice have been raised. Currently, it is unknown whether other practicing professionals could deliver interventions in the community with efficacy similar to that of the interventionists of the DPP, who were trained in counseling on nutrition, exercise, and behavior modification. The investigators propose the use of telemedicine with applications in an interactive web-based system. This will allow participants to get just-in-time feedback from peers using targeted information on specific areas that need reinforcement to adopt healthy lifestyle and better self-management skills by older veterans. This will bolster the peer-participant interaction and make them more focused around areas where there are adoption gaps. This technology functions as a platform for social interaction that will lead to increase self-efficacy and better health outcomes.
The VA National Center for Health Promotion and Disease Prevention (NCP) developed the MOVE! weight management program based on the 1998/2000 Identification and Treatment of Overweight and Obesity in Adults Evidence Report. A major goal for the MOVE! program has been to reduce the prevalence of diabetes in veterans. Our long-term goal is to reduce the burden of obesity-related chronic diseases and promote healthy aging in older veterans through the implementation of best practices for prevention. The main objective of this project is to implement evidence-informed, innovative interventions to increase adoption of findings from comparative effectiveness research (CER) for diabetes management prevention in South Florida older veterans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth (TAP) | Experimental | Behavioral: Telehealth Intervention |
| Peer-led care (PC) | Experimental | Behavioral: Peer-led intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60 years and older
- Enrolled in HARC program
- Body mass index (BMI) ≥ 25 kg/m²
- Diagnosed diabetes or prediabetes [ADA 2003 criteria] HbA1c ≥ 5.7%
- Able to operate a telemedicine device, respond to text queries, and use his/her glucose meter, a blood pressure monitor, and a scale for daily weights
Key exclusion criteria (4 listed)
- End-stage illness
- Anticipated survival less than 12 months
- Imminent nursing home placement
- Diagnosis of psychosis or significant cognitive impairment/dementia
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 |
|---|---|---|
| Peer-led interventionAlso: PCAn expert patient in the peer-led intervention will provide effective support for patients and families to accelerate adoption of CER for diabetes prevention and management in the elderly. This will lead to better self-efficacy and clinical outcomes. Those veterans enrolled in the MOVE! and HARC programs that have showed success in management of weight and Diabetes will be offered to become peer-leaders. * Weight management success is defined as a loss of at least 5% of the weight since enrollment * Diabetes management will be defined as adequate control of HbA1c and/ or blood pressure and lipids. The potentials peer-leaders will have a pre-assessment test to evaluate diabetes prevention and management knowledge and motivation and support skills. | Behavioural | Peer-led care (PC) |
| Telehealth InterventionAlso: TAPParticipants in the TAP group will receive mobile phones that will be programmed to monitor specific clinical parameters and promote adoption of CER on prevention and management of diabetes, with protocols developed in part based on the input from the focus groups. These devices display messages, tips, reminders and questions regarding healthy lifestyle and clinical parameters of diabetes, which will be developed using best practice guidelines. Participants will be asked to respond to the questions daily if they can. Also they are asked to provide their daily weight, blood pressure, and glucose levels (the later only for patients with diabetes). | Behavioural | Telehealth (TAP) |
Primary outcome
Compare changes in self-efficacy between participants receiving peer-led care (with or without TAP intervention) and those receiving UC over 12 months.
Time frame: 12 months
Compare changes in weight and hemoglobin A1c between participants receiving peer-led care (with or without TAP intervention) and those receiving UC over 12 months.
Time frame: 12 months
3 secondary outcomes
Compare changes in weight, hemoglobin A1c, and self-efficacy between white-non-hispanics and minorities over 12 months.
Time frame: 12 months
Compare changes in blood pressure, lipids, physical function, and quality of life among treatment groups (UC, PC, and TAP).
Time frame: 12 months
Compare changes in health care utilization (physician visits, emergency visits, and days in hospital) among treatment groups (UC, PC, and TAP).
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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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.
Lisset Oropesa, MD study director
Miami VAMC
Hermes J Florez, MD principal investigator
Miami VAMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led intervention and Telehealth Intervention in people with Diabetes and Pre-diabetes, run by South Florida Veterans Affairs Foundation for Research and Education at 2 sites in United States.
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 5 inclusion and 4 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 2 Mar 2011. 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare changes in self-efficacy between participants receiving peer-led care (with or without TAP intervention) and those receiving UC over 12 months. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 2 Mar 2011.