Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 24, 2012 | ||||||||
| Last Updated Date | September 20, 2012 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in Glucose Control [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ] Measured by change in HbA1c |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01651117 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control | ||||||||
| Official Title ICMJE | Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control (CEPACT) | ||||||||
| Brief Summary | The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic veterans. Also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. It is expected that that participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention. |
||||||||
| Detailed Description | The primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control in a mixed race population of poorly controlled diabetic veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) determine the cost-effectiveness of peer mentoring as implemented in this study. Secondary objectives include: (1) assess the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health; and (2) assess the effects of the program on other important health outcomes for diabetics including blood pressure, low density lipoprotein (LDL) levels, diabetes quality of life, and depression. This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, direct LDL, diabetes quality of life and depression. We will also perform a cost-effectiveness analysis of the different interventions compared to the control arm. We will take the perspective of the payer. The trial has 3 arms: 1. usual care; 2. peer mentoring where mentors are veterans who were once in poor control but are now in good control; and 3. peer mentoring where the mentoring comes from former mentees. Qualitative interviews with participants will provide an additional layer of insight. Determining how best to create sustainable peer mentoring models will create for the VA a new powerful tool with the potential for improving chronic disease outcomes and reducing disparities, and it will demonstrate VA leadership in creating models exportable to other settings. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Type 2 Diabetes Mellitus | ||||||||
| Intervention ICMJE | Behavioral: Peer Mentoring
Arm 2: Will receive peer mentoring from diabetic veterans who were once in poor control but are now in good control. Arm 3: Will receive peer mentoring from former mentees. |
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 360 | ||||||||
| Estimated Completion Date | October 2014 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 30 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01651117 | ||||||||
| Other Study ID Numbers ICMJE | 01373 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Judith Long, MD, Philadelphia Veterans Affairs Medical Center | ||||||||
| Study Sponsor ICMJE | Philadelphia Veterans Affairs Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Philadelphia Veterans Affairs Medical Center | ||||||||
| Verification Date | September 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||