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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peer partner | Experimental | Veterans with at least one CVD risk factor who are interesting in increasing heart healthy behaviors through peer support |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Goldstein, MD MSPH | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Peer Coach |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Enrollment | Number of participants contacted, screened and enrolled in the pilot | Number of participants contacted for participation | Posted | Count of Participants | Participants | 12 weeks |
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time of consent to end of study participation, 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| exacerbation of existing Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment | occurred after consent and before intervention initiation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Goldstein | Department of Veterans Administration | 919.826.0411 | 1707764 | karen.goldstein@va.gov |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2018 | Mar 6, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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single group assignment
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| 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. | 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. | 12 weeks |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Feasibility Retention | Retention rates from consent to enrollment and from enrollment to completion of study. | Posted | Count of Participants | Participants | 12 weeks |
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| Primary | Acceptability | Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions. | participants who attended at least 1 group session | Posted | Mean | Full Range | group sessions attended per participant | 12 weeks |
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| Primary | Acceptability - Weeks Contact With Peer Buddy | Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) | Posted | Mean | Full Range | weeks | 12 weeks |
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| 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. | Posted | Count of Participants | Participants | 12 weeks |
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| 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. | participants by gender contacted by invitation letter for study participation | Posted | Count of Participants | Participants | 12 weeks |
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| 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. | consented participants by gender | Posted | Mean | Full Range | weeks | 12 weeks |
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| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 2 | 3 |
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| passed gallstones | Eye disorders | Non-systematic Assessment |
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| knee injury in snow | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| shoulder surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | surgery planned prior to consent |
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| upper respiratory infection | Infections and infestations | Non-systematic Assessment |
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| consented |
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