Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
NCT ID: NCT01651117
Last Updated: 2019-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
480 participants
INTERVENTIONAL
2012-09-01
2018-10-08
Brief Summary
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Detailed Description
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This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, blood pressure, direct LDL, diabetes quality of life and depression.
The trial has two phases. In phase one, patients with poorly controlled diabetes are randomized to usual care or receiving peer mentoring. In phase two, poorly controlled diabetics are randomized to usual care or receiving peer mentoring from former mentees. Former mentees from phase 1 are also randomized such that they will have a 50% chance of becoming a mentor.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Usual Care
Enrolled in two different time frames. No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
No interventions assigned to this group
Peer Mentoring
Participants in this arm will be mentored for 6 months by a veteran who was once in poor control but is now in good control. They will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.
Peer Mentoring
Patients will receive peer mentoring.
Peer Mentoring FFM (from former mentee)
Participants in this arm will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Peer Mentoring
Patients will receive peer mentoring.
Interventions
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Peer Mentoring
Patients will receive peer mentoring.
Eligibility Criteria
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Inclusion Criteria
* Diabetes began after age 30
* Mentees: Have an HbA1c \> 8% on 2 different occasions in the course of 24 months, with at least one measure within 3 months of enrollment
* Mentors for Phase 1: Had an HbA1c of \> 8% in the past 3 years and an HbA1c \< (or equal to) 7.5% within 3 months of enrollment
* Mentors for Phase 2: Former mentee
Exclusion Criteria
* Unable to understand consents
* Severe speech impediment
* over the age of 75
30 Years
75 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Judith A. Long, MD
Role: PRINCIPAL_INVESTIGATOR
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Locations
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Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
Countries
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References
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Long JA, Ganetsky VS, Canamucio A, Dicks TN, Heisler M, Marcus SC. Effect of Peer Mentors in Diabetes Self-management vs Usual Care on Outcomes in US Veterans With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2016369. doi: 10.1001/jamanetworkopen.2020.16369.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IIR 12-407
Identifier Type: -
Identifier Source: org_study_id
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