Heart Health Buddies: Peer Support to Decrease CVD Risk

Cardiovascular Disease Clinical Trial

— HHB  

Official title:

Heart Health Buddies: Peer Support to Decrease Cardiovascular Risk (CDA 13-263)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646656
• Other study ID #: CDX 18-005
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

Inclusion Criteria:

Peer partners and peer coaches:

• Enrolled in a Durham Veterans Administration Health Care System primary care clinic (including the women's health clinic)

• At risk for cardiovascular disease as defined by having at least one of the following:

• Uncontrolled hypertension

• history of obesity defined as (BMI >30)

• uncontrolled non-insulin dependent diabetes mellitus

• In addition, Peer coaches have made and sustained a behavioral change in past 3-6 months to improve heart health

• English as preferred language

• no significant hearing impairment

• lives approximately 30 minutes from the Durham Veterans affairs Medical Center

• agrees to attend regular visits per study protocol

• no contraindication to engage in at least moderate physical activity

• willing to use personal phone for peer and coach contacts

Exclusion Criteria:

• insulin-dependent diabetes

• serious mental illness defined as schizophrenia, bipolar disorder, dementia, active psychosis psychiatric hospitalization within the last 12 months or current high-risk suicide flag in their electronic medical record

• active substance use as documented in electronic or positive screening during telephone screening

• limited Life expectancy (<6 months) or severely ill defined as enrolled in hospice or actively undergoing chemotherapy or radiation therapy for cancer

• currently pregnant or planning to become pregnant in next 6 months

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• reciprocal peer support and non reciprocal coach support
Peers and peer coaches provide mutual or one-way support to initiate and sustain behavioral improvements for cardiovascular health, with additional education from study staff.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Enrollment	Number of participants contacted, screened and enrolled in the pilot	12 weeks
Primary	Feasibility Retention	Retention rates from consent to enrollment and from enrollment to completion of study.	12 weeks
Primary	Acceptability	Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions.	12 weeks
Primary	Acceptability - Weeks Contact With Peer Buddy	Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches)	12 weeks
Secondary	Gender Differences - Retention	Quantitative and qualitative gender differences in feasibility and acceptance will be evaluated through quantitative differences in enrollment, retention and frequency of peer contacts, and qualitative comparison of participant-reported experiences with intervention content, peer and group interactions by gender. Data are presented only for reciprocal peer partner group as this was pre-specified to compare outcomes between men and women in the reciprocal peer partner group. Thus, peer coaches are not described in this outcome.	12 weeks
Secondary	Gender Differences-enrollment	Quantitative and qualitative gender differences in feasibility and acceptance will be evaluated through quantitative differences in enrollment, retention and frequency of peer contacts, and qualitative comparison of participant-reported experiences with intervention content, peer and group interactions by gender. Data are presented only for reciprocal peer partner group as this was pre-specified to compare outcomes between men and women in the reciprocal peer partner group. Thus, peer coaches are not described in this outcome.	12 weeks
Secondary	Gender Differences - Mean Contacts Per Buddy Pair	Quantitative and qualitative gender differences in feasibility and acceptance will be evaluated through quantitative differences in enrollment, retention and frequency of peer contacts, and qualitative comparison of participant-reported experiences with intervention content, peer and group interactions by gender.	12 weeks