Clinical trial NCT03646656: Heart Health Buddies: Peer Support to Decrease CVD Risk
Official title: Heart Health Buddies: Peer Support to Decrease Cardiovascular Risk (CDA 13-263)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: cardiovascular disease
social support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-08-24
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: single group assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Enrollment
timeFrame: 12 weeks
measure: Feasibility Retention
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
measure: Acceptability - Weeks Contact With Peer Buddy
timeFrame: 12 weeks
Secondary outcomes:
measure: Gender Differences - Retention
timeFrame: 12 weeks
measure: Gender Differences-enrollment
timeFrame: 12 weeks
measure: Gender Differences - Mean Contacts Per Buddy Pair
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Karen Goldstein, MD MSPH
role: PRINCIPAL_INVESTIGATOR
References: