Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03646656 |
Other study ID # |
CDX 18-005 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 26, 2018 |
Est. completion date |
March 15, 2019 |
Study information
Verified date |
July 2023 |
Source |
VA Office of Research and Development |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This pilot study will use a hybrid reciprocal peer support and peer coach model to initiate
and sustain heart-healthy behavioral changes in Veterans. Veterans who are at-risk for
cardiovascular disease (CVD) will be enrolled in the study and paired with another Veteran to
receive and provide social support around engaging in CVD risk reduction behaviors. Enrolled
participants will be offered a series of 3 group sessions focused on CVD risk reduction, goal
setting and action plan development. Between group sessions, peer partners will be asked to
have weekly calls to discuss action plan challenges, explore options for problem solving, and
provide encouragement and accountability for personal goals. Participants who do not engage
in the group sessions or weekly phone calls, or who request additional help, will receive
support from trained peer coaches. The goal of this pilot study is to evaluate the proof of
concept for a hybrid reciprocal peer support (RPS) and peer coach intervention to improve
heart healthy behaviors among Veterans at risk for CVD.
Description:
A total of 24 Veterans enrolled at the Durham Veterans Affairs Medical Center will be
screened and enrolled. Eligible Veterans are 35-64 years old, with at least one uncontrolled
or poorly controlled risk factor for CVD. In addition, 3-6 veterans will be enrolled and
trained as heart health peer coaches, with eligibility being 35-64 years old, with at least
one documented CVD factor who have sustained improvement in physical activity or dietary
change in the previous 3-6 months. All participants complete a baseline assessment, three
structured group meetings, and a 12 week post-intervention assessment. At the first group,
each participant creates a behavioral goal, and peer partners are paired with another Veteran
based on behavioral goal and gender. They are expected to call their peer once a week to
discuss progress or difficulty with their action plan and support each other with problem
solving. Post enrollment and prior to the first group meeting, Peer coaches will have 3-5
hours of motivational and communication training with study staff focusing on skills such as
active listening, non-directive support, eliciting change-talk, promoting incremental change,
and patient confidentiality. Peer coaches will interact with peer buddies during a) group
sessions, b) at a 6 week phone check-in, and c) on-going support if needed. Additional
support will be initiated if there are no phone calls between pairs, there is a lack of
participant engagement in calls to partner or attending group sessions, or upon request by
the peer. There are two Aims of the current pilot study. Aim 1: examine the feasibility and
acceptability of a 12-week hybrid peer coach-reciprocal peer support intervention.
Feasibility will be evaluated by ease of recruitment, and enrollment and retention rates.
Acceptability will be assessed by self-report of amount, frequency and modality of contacts,
participation rates for group sessions, and through post-intervention qualitative interviews.
Aim 2: explore gender differences in feasibility/acceptability of the hybrid peer support
model. Gender differences will be evaluated through qualitative comparison of participant
reported experiences with intervention content as well as peer and group interactions by
gender; and, quantitatively via exploration of differences in enrollment, retention, refusal
reasons and frequency of peer contacts.