Cardiovascular DiseaseHHBNCT03646656
Heart Health Buddies: Peer Support to Decrease CVD Risk
A study testing reciprocal peer support and non reciprocal coach support in people with Cardiovascular Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 64 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- reciprocal peer support and non reciprocal coach support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2018to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: Heart Health Buddies: Peer Support to Decrease Cardiovascular Risk (CDA 13-263)
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- reciprocal peer support and non reciprocal coach support
- Keywords
- cardiovascular disease, social support
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reciprocal peer support and non reciprocal coach supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| peer partner | Experimental | Veterans with at least one CVD risk factor who are interesting in increasing heart healthy behaviors through peer support Receives: 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. Receives: Behavioral: reciprocal peer support and non reciprocal coach support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment
Number of participants contacted, screened and enrolled in the pilot
Measured: 12 weeks
Feasibility Retention
Retention rates from consent to enrollment and from enrollment to completion of study.
Measured: 12 weeks
Acceptability
Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions.
Measured: 12 weeks
Acceptability - Weeks Contact With Peer Buddy
Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches)
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start26 Sep 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- single group assignment
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karen Goldstein, MD MSPH, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646656
- Sponsor's protocol ID
- CDX 18-005
- Acronym
- HHB
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2018
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will be given personal feedback during the course of the study, such as during their baseline and 12 week assessments (weight, bp, and exercise scores), and via an activity monitor they will wear to monitor their daily activity. Participants will receive individual feedback, but as this is a feasibility study we do not intend to share study outcome results with participants.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Health Buddies: Peer Support to Decrease Cardiovascular Risk (CDA 13-263)
- ClinicalTrials.gov ID
- NCT03646656
- Acronym / sponsor ID
- HHB / CDX 18-005
- Conditions
- Cardiovascular Disease
- Keywords
- cardiovascular disease, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single group assignment
| Arm | Type | Receives |
|---|---|---|
| peer partner | Experimental | Behavioral: reciprocal peer support and non reciprocal coach supportVeterans with at least one CVD risk factor who are interesting in increasing heart healthy behaviors through peer support |
| peer coach | Other | Behavioral: reciprocal peer support and non reciprocal coach supportVeterans 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. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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:
- English as preferred language
- no significant hearing impairment
- lives approximately 30 minutes from the Durham Veterans affairs Medical Center
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reciprocal peer support and non reciprocal coach supportPeers and peer coaches provide mutual or one-way support to initiate and sustain behavioral improvements for cardiovascular health, with additional education from study staff. | Behavioural | peer coach, peer partner |
Primary outcome
Feasibility of Enrollment
Time frame: 12 weeks
Number of participants contacted, screened and enrolled in the pilot
Feasibility Retention
Time frame: 12 weeks
Retention rates from consent to enrollment and from enrollment to completion of study.
Acceptability
Time frame: 12 weeks
Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions.
Acceptability - Weeks Contact With Peer Buddy
Time frame: 12 weeks
Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches)
3 secondary outcomes
Gender Differences - Retention
Time frame: 12 weeks
Gender Differences-enrollment
Time frame: 12 weeks
Gender Differences - Mean Contacts Per Buddy Pair
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Participants will be given personal feedback during the course of the study, such as during their baseline and 12 week assessments (weight, bp, and exercise scores), and via an activity monitor they will wear to monitor their daily activity. Participants will receive individual feedback, but as this is a feasibility study we do not intend to share study outcome results with participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Goldstein, MD MSPH principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reciprocal peer support and non reciprocal coach support in people with Cardiovascular Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.