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Heart Health Buddies: Peer Support to Decrease CVD Risk

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03646656
Acronym
HHB
Enrollment
15
Registered
2018-08-24
Start date
2018-09-26
Completion date
2019-03-15
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

cardiovascular disease, social support

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.

Interventions

BEHAVIORALreciprocal 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

single group assignment

Eligibility

Sex/Gender
ALL
Age
35 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Enrollment12 weeksNumber of participants contacted, screened and enrolled in the pilot
Feasibility Retention12 weeksRetention rates from consent to enrollment and from enrollment to completion of study.
Acceptability12 weeksAcceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions.
Acceptability - Weeks Contact With Peer Buddy12 weeksAcceptability of study based on successful peer buddy contacts per pair (not applicable to coaches)

Secondary

MeasureTime frameDescription
Gender Differences-enrollment12 weeksQuantitative 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.
Gender Differences - Mean Contacts Per Buddy Pair12 weeksQuantitative 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.
Gender Differences - Retention12 weeksQuantitative 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Reciprocal Peer Partner
Veterans with at least one cardiovascular disease risk factor who are interested in increasing heart healthy behaviors through peer support receive phone-based weekly support from a reciprocal peer support partner and as needed help from a peer coach.
12
Peer Coach
Veterans with at least one cardiovascular disease risk factor who have made and sustained changes in diet or exercise in the past 3-6 months prior to enrollment serve as peer coaches and provide supplemental one-way support to reciprocal peer partners as needed.
3
Total15

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up10
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicReciprocal Peer PartnerTotalPeer Coach
Age, Continuous54.42 years
STANDARD_DEVIATION 7.39
55.87 years
STANDARD_DEVIATION 7.25
61.67 years
STANDARD_DEVIATION 2.08
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants13 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants9 Participants2 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
3 Participants3 Participants0 Participants
Region of Enrollment
United States
12 Participants15 Participants3 Participants
Sex: Female, Male
Female
6 Participants7 Participants1 Participants
Sex: Female, Male
Male
6 Participants8 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 3
other
Total, other adverse events
3 / 122 / 3
serious
Total, serious adverse events
0 / 120 / 3

Outcome results

Primary

Acceptability

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

Time frame: 12 weeks

Population: participants who attended at least 1 group session

ArmMeasureValue (MEAN)
Reciprocal Peer PartnerAcceptability2.1 group sessions attended per participant
Peer CoachAcceptability2 group sessions attended per participant
Primary

Acceptability - Weeks Contact With Peer Buddy

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

Time frame: 12 weeks

ArmMeasureValue (MEAN)
Reciprocal Peer PartnerAcceptability - Weeks Contact With Peer Buddy8.33 weeks
Primary

Feasibility of Enrollment

Number of participants contacted, screened and enrolled in the pilot

Time frame: 12 weeks

Population: Number of participants contacted for participation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Reciprocal Peer PartnerFeasibility of Enrollmentcontacted but not screened25 Participants
Reciprocal Peer PartnerFeasibility of Enrollmentscreened by not enrolled13 Participants
Reciprocal Peer PartnerFeasibility of Enrollmentconsented12 Participants
Peer CoachFeasibility of Enrollmentcontacted but not screened7 Participants
Peer CoachFeasibility of Enrollmentscreened by not enrolled0 Participants
Peer CoachFeasibility of Enrollmentconsented3 Participants
Primary

Feasibility Retention

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

Time frame: 12 weeks

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Reciprocal Peer PartnerFeasibility Retentiondid not complete study3 Participants
Reciprocal Peer PartnerFeasibility Retentioncompleted study9 Participants
Peer CoachFeasibility Retentiondid not complete study0 Participants
Peer CoachFeasibility Retentioncompleted study3 Participants
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.

Time frame: 12 weeks

Population: participants by gender contacted by invitation letter for study participation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Reciprocal Peer PartnerGender Differences-enrollmentsent invitation letter by not reached by phone17 Participants
Reciprocal Peer PartnerGender Differences-enrollmentreached by phone but not consented6 Participants
Reciprocal Peer PartnerGender Differences-enrollmentconsented6 Participants
Peer CoachGender Differences-enrollmentsent invitation letter by not reached by phone11 Participants
Peer CoachGender Differences-enrollmentreached by phone but not consented4 Participants
Peer CoachGender Differences-enrollmentconsented6 Participants
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.

Time frame: 12 weeks

Population: consented participants by gender

ArmMeasureValue (MEAN)
Reciprocal Peer PartnerGender Differences - Mean Contacts Per Buddy Pair9 weeks
Peer CoachGender Differences - Mean Contacts Per Buddy Pair7.66 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.

Time frame: 12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Reciprocal Peer PartnerGender Differences - Retention5 Participants
Peer CoachGender Differences - Retention4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026