Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-10 @ 3:33 PM
Study NCT ID:
NCT03646656
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2018-08-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Heart Health Buddies: Peer Support to Decrease CVD Risk
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Heart Health Buddies: Peer Support to Decrease Cardiovascular Risk (CDA 13-263)
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HHB
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: