Trial Outcomes & Findings for Heart Health Buddies: Peer Support to Decrease CVD Risk (NCT NCT03646656)
NCT ID: NCT03646656
Last Updated: 2023-07-27
Results Overview
Number of participants contacted, screened and enrolled in the pilot
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
3
|
|
Overall Study
Attended 1st Group Session
|
10
|
3
|
|
Overall Study
COMPLETED
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Heart Health Buddies: Peer Support to Decrease CVD Risk
Baseline characteristics by cohort
| Measure |
Reciprocal Peer Partner
n=12 Participants
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.
|
Peer Coach
n=3 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.42 years
STANDARD_DEVIATION 7.39 • n=5 Participants
|
61.67 years
STANDARD_DEVIATION 2.08 • n=7 Participants
|
55.87 years
STANDARD_DEVIATION 7.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Number of participants contacted for participation
Number of participants contacted, screened and enrolled in the pilot
Outcome measures
| Measure |
Reciprocal Peer Partner
n=50 Participants
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.
|
Peer Coach
n=10 Participants
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.
|
|---|---|---|
|
Feasibility of Enrollment
contacted but not screened
|
25 Participants
|
7 Participants
|
|
Feasibility of Enrollment
screened by not enrolled
|
13 Participants
|
0 Participants
|
|
Feasibility of Enrollment
consented
|
12 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12 weeksRetention rates from consent to enrollment and from enrollment to completion of study.
Outcome measures
| Measure |
Reciprocal Peer Partner
n=12 Participants
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.
|
Peer Coach
n=3 Participants
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.
|
|---|---|---|
|
Feasibility Retention
completed study
|
9 Participants
|
3 Participants
|
|
Feasibility Retention
did not complete study
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: participants who attended at least 1 group session
Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions.
Outcome measures
| Measure |
Reciprocal Peer Partner
n=10 Participants
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.
|
Peer Coach
n=3 Participants
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.
|
|---|---|---|
|
Acceptability
|
2.1 group sessions attended per participant
Interval 1.0 to 3.0
|
2 group sessions attended per participant
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: 12 weeksAcceptability of study based on successful peer buddy contacts per pair (not applicable to coaches)
Outcome measures
| Measure |
Reciprocal Peer Partner
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Acceptability - Weeks Contact With Peer Buddy
|
8.33 weeks
Interval 6.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Reciprocal Peer Partner
n=6 Participants
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.
|
Peer Coach
n=6 Participants
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.
|
|---|---|---|
|
Gender Differences - Retention
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: participants by gender contacted by invitation letter for study participation
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.
Outcome measures
| Measure |
Reciprocal Peer Partner
n=29 Participants
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.
|
Peer Coach
n=21 Participants
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.
|
|---|---|---|
|
Gender Differences-enrollment
consented
|
6 Participants
|
6 Participants
|
|
Gender Differences-enrollment
sent invitation letter by not reached by phone
|
17 Participants
|
11 Participants
|
|
Gender Differences-enrollment
reached by phone but not consented
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: consented participants by gender
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.
Outcome measures
| Measure |
Reciprocal Peer Partner
n=6 Participants
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.
|
Peer Coach
n=6 Participants
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.
|
|---|---|---|
|
Gender Differences - Mean Contacts Per Buddy Pair
|
9 weeks
Interval 9.0 to 9.0
|
7.66 weeks
Interval 6.0 to 10.0
|
Adverse Events
Reciprocal Peer Partner
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Peer Coach
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reciprocal Peer Partner
n=12 participants at risk
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.
|
Peer Coach
n=3 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
exacerbation of existing Crohn's disease
|
8.3%
1/12 • Number of events 1 • time of consent to end of study participation, 12 weeks
|
0.00%
0/3 • time of consent to end of study participation, 12 weeks
|
|
Eye disorders
passed gallstones
|
8.3%
1/12 • Number of events 1 • time of consent to end of study participation, 12 weeks
|
0.00%
0/3 • time of consent to end of study participation, 12 weeks
|
|
Musculoskeletal and connective tissue disorders
knee injury in snow
|
0.00%
0/12 • time of consent to end of study participation, 12 weeks
|
33.3%
1/3 • Number of events 1 • time of consent to end of study participation, 12 weeks
|
|
Musculoskeletal and connective tissue disorders
shoulder surgery
|
0.00%
0/12 • time of consent to end of study participation, 12 weeks
|
33.3%
1/3 • Number of events 1 • time of consent to end of study participation, 12 weeks
|
|
Infections and infestations
upper respiratory infection
|
8.3%
1/12 • Number of events 1 • time of consent to end of study participation, 12 weeks
|
0.00%
0/3 • time of consent to end of study participation, 12 weeks
|
Additional Information
Dr. Karen Goldstein
Department of Veterans Administration
Phone: 919.826.0411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place