Heart Health Buddies: Peer Support to Decrease CVD Risk

NCT03646656 | Completed Results

• 1 other identifier: CDX 18-005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

cardiovascular disease; social support

Outcome Measures

Primary Outcomes (4)

• Feasibility of Enrollment

  Number of participants contacted, screened and enrolled in the pilot

  12 weeks

• Feasibility Retention

  Retention rates from consent to enrollment and from enrollment to completion of study.

  12 weeks

• Acceptability

  Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions.

  12 weeks

• Acceptability - Weeks Contact With Peer Buddy

  Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches)

  12 weeks

Secondary Outcomes (3)

• Gender Differences - Retention

  12 weeks

• Gender Differences-enrollment

  12 weeks

• Gender Differences - Mean Contacts Per Buddy Pair

  12 weeks

Study Arms (2)

peer partner

EXPERIMENTAL

Veterans with at least one CVD risk factor who are interesting in increasing heart healthy behaviors through peer support

Behavioral: reciprocal peer support and non reciprocal coach support

peer coach

OTHER

Veterans with at least one CVD risk factor who have made and sustained changes in diet or exercise in the past 3-6 months prior to enrollment. While the investigators will collect data on peer coach participants, their participation is primarily as part of intervention to examine the feasibility and benefit of adding peer coaching to a peer partner intervention.

Behavioral: reciprocal peer support and non reciprocal coach support

Interventions

reciprocal peer support and non reciprocal coach support BEHAVIORAL

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.

peer coach; peer partner

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Karen Goldstein
• Organization: Department of Veterans Administration

karen.goldstein@va.gov

919.826.0411

Study Officials

• Karen Goldstein, MD MSPH

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: single group assignment

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: September 26, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: July 27, 2023
• Results First Posted: March 23, 2020

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)