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Peer-led and Telehealth Comparative Effectiveness Research (CER) Adoption for Diabetes Prevention and Management

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ClinicalTrials.gov Identifier: NCT01307137
Recruitment Status : Unknown
Verified January 2011 by South Florida Veterans Affairs Foundation for Research and Education.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:
South Florida Veterans Affairs Foundation for Research and Education

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Diabetes Pre-diabetes Behavioral: Peer-led intervention Behavioral: Telehealth Intervention Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Peer-lead and Telemedicine Activated Care (PACT) in Diabetes Prevention and Management
Study Start Date : June 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adoption

Arms and Interventions
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Arm Intervention/treatment
Experimental: Telehealth (TAP) Behavioral: Telehealth Intervention
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).
Other Name: TAP
Experimental: Peer-led care (PC) Behavioral: Peer-led intervention

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.

Other Name: PC


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Compare changes in weight, hemoglobin A1c, and self-efficacy between white-non-hispanics and minorities over 12 months. [ Time Frame: 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.

  2. Compare changes in blood pressure, lipids, physical function, and quality of life among treatment groups (UC, PC, and TAP). [ Time Frame: 12 months ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 60 years and older
  2. Enrolled in HARC program
  3. Body mass index (BMI) ≥ 25 kg/m²
  4. Diagnosed diabetes or prediabetes [ADA 2003 criteria] HbA1c ≥ 5.7%
  5. 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

Exclusion Criteria:

  1. End-stage illness
  2. Anticipated survival less than 12 months
  3. Imminent nursing home placement
  4. Diagnosis of psychosis or significant cognitive impairment/dementia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307137


Locations
United States, Florida
Miami VAMC Not yet recruiting
Miami, Florida, United States, 33125
Contact: Lisset Oropesa, MD, MS    305-794-2669    lisset.oropesa@va.gov   
Principal Investigator: Hermes J Florez, MD, MPH, PhD         
University of Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
South Florida Veterans Affairs Foundation for Research and Education
Investigators
Study Director: Lisset Oropesa, MD Miami VAMC
Principal Investigator: Hermes J Florez, MD Miami VAMC
More Information
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Responsible Party: Hermes Florez, MD, MPH, PhD, Miami VAMC
ClinicalTrials.gov Identifier: NCT01307137     History of Changes
Other Study ID Numbers: 00915
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia