HHB: Heart Health Buddies: Peer Support to Decrease CVD Risk

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03646656
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Behavioral: reciprocal peer support and non reciprocal coach support	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: single group assignmentsingle group assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Heart Health Buddies: Peer Support to Decrease Cardiovascular Risk (CDA 13-263)
• Actual Study Start Date: Sep 26, 2018
• Actual Primary Completion Date: Mar 15, 2019
• Actual Study Completion Date: Mar 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: peer partner 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; 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.
Other: peer coach 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; 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.

Outcome Measures

Primary Outcome Measures

1. Feasibility of Enrollment [12 weeks]

   Number of participants contacted, screened and enrolled in the pilot

2. Feasibility Retention [12 weeks]

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

3. Acceptability [12 weeks]

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

4. Acceptability - Weeks Contact With Peer Buddy [12 weeks]

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

Secondary Outcome Measures

1. Gender Differences - Retention [12 weeks]

   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.

2. Gender Differences-enrollment [12 weeks]

   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.

3. Gender Differences - Mean Contacts Per Buddy Pair [12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Karen Goldstein, MD MSPH, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

• Study Protocol - Aug 10, 2018

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03646656
• Other Study ID Numbers: CDX 18-005
• First Posted: Aug 24, 2018
• Last Update Posted: Mar 23, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: cardiovascular disease; social support
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

Participant Flow

Arm/Group Title	Reciprocal Peer Partner	Peer Coach
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	12	3
Attended 1st Group Session	10	3
COMPLETED	9	3
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Reciprocal Peer Partner	Peer Coach	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	12	3	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.42 (7.39)	61.67 (2.08)	55.87 (7.25)
Sex: Female, Male (Count of Participants)
Female	6 50%	1 33.3%	7 46.7%
Male	6 50%	2 66.7%	8 53.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 8.3%	1 33.3%	2 13.3%
Not Hispanic or Latino	11 91.7%	2 66.7%	13 86.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 58.3%	2 66.7%	9 60%
White	3 25%	0 0%	3 20%
More than one race	2 16.7%	1 33.3%	3 20%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	12 100%	3 100%	15 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Enrollment
Description	Number of participants contacted, screened and enrolled in the pilot
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Number of participants contacted for participation

Arm/Group Title	Reciprocal Peer Partner	Peer Coach
Arm/Group Description	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.	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.
Measure Participants	50	10
contacted but not screened	25 208.3%	7 233.3%
screened by not enrolled	13 108.3%	0 0%
consented	12 100%	3 100%

2. Primary Outcome

Title	Feasibility Retention
Description	Retention rates from consent to enrollment and from enrollment to completion of study.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reciprocal Peer Partner	Peer Coach
Arm/Group Description	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.	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.
Measure Participants	12	3
completed study	9 75%	3 100%
did not complete study	3 25%	0 0%

3. Primary Outcome

Title	Acceptability
Description	Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

participants who attended at least 1 group session

Arm/Group Title	Reciprocal Peer Partner	Peer Coach
Arm/Group Description	Veterans with at least one CVD 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.	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 serve as peer coaches and provide supplemental one-way support to reciprocal peer partners as needed.
Measure Participants	10	3
Mean (Full Range) [group sessions attended per participant]	2.1	2

4. Primary Outcome

Title	Acceptability - Weeks Contact With Peer Buddy
Description	Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reciprocal Peer Partner
Arm/Group Description	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.
Measure Participants	10
Mean (Full Range) [weeks]	8.33

5. Secondary Outcome

Title	Gender Differences - Retention
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reciprocal Peer Partner - Female	Reciprocal Peer Partner - Male
Arm/Group Description	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.	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.
Measure Participants	6	6
Count of Participants [Participants]	5 41.7%	4 133.3%

6. Secondary Outcome

Title	Gender Differences-enrollment
Description	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

Outcome Measure Data

Analysis Population Description

participants by gender contacted by invitation letter for study participation

Arm/Group Title	Reciprocal Peer Partner - Female	Reciprocal Peer Partner - Male
Arm/Group Description	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.	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.
Measure Participants	29	21
sent invitation letter by not reached by phone	17 141.7%	11 366.7%
reached by phone but not consented	6 50%	4 133.3%
consented	6 50%	6 200%

7. Secondary Outcome

Title	Gender Differences - Mean Contacts Per Buddy Pair
Description	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

Outcome Measure Data

Analysis Population Description

consented participants by gender

Arm/Group Title	Reciprocal Peer Partner - Female	Reciprocal Peer Partner - Male
Arm/Group Description	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.	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.
Measure Participants	6	6
Mean (Full Range) [weeks]	9	7.66

Adverse Events

Time Frame	time of consent to end of study participation, 12 weeks
Arm/Group Title	Reciprocal Peer Partner		Peer Coach
Arm/Group Description	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.		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.
All Cause Mortality
	Reciprocal Peer Partner		Peer Coach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/3 (0%)
Serious Adverse Events
	Reciprocal Peer Partner		Peer Coach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Reciprocal Peer Partner		Peer Coach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/12 (25%)		2/3 (66.7%)
Eye disorders
passed gallstones	1/12 (8.3%)	1	0/3 (0%)	0
Gastrointestinal disorders
exacerbation of existing Crohn's disease	1/12 (8.3%)	1	0/3 (0%)	0
Infections and infestations
upper respiratory infection	1/12 (8.3%)	1	0/3 (0%)	0
Musculoskeletal and connective tissue disorders
knee injury in snow	0/12 (0%)	0	1/3 (33.3%)	1
shoulder surgery	0/12 (0%)	0	1/3 (33.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.