Peer Coaching for Cardiovascular Disease Risk Reduction

(RePeAT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Prior cardiac event, Vascular disease, Lack of consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study, Re-thinking the role of Peers And Training Patients \[RePeAT\], is designed to test the feasibility of training peer-coaches to prepare limited health literacy (LHL) patients to engage in shared-decision making (SDM) for cardiovascular disease (CVD) risk-reduction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is peer coaching for cardiovascular disease risk reduction safe for humans?

Peer coaching interventions, such as those encouraging a Mediterranean diet or lifestyle changes for obesity, have been studied in various groups and are generally considered safe. These interventions focus on behavior change and support, rather than medical treatments, and no significant safety concerns have been reported in the studies reviewed. ^{1 2 3 4 5}

How does the peer coaching treatment for cardiovascular disease risk reduction differ from other treatments?

Peer coaching for cardiovascular disease risk reduction is unique because it involves support from individuals with similar experiences to help patients manage their health. This approach focuses on building trust and accountability between peers, which can enhance motivation and adherence to heart-healthy behaviors, unlike traditional medical treatments that primarily rely on healthcare professionals. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Peer Coach for cardiovascular disease risk reduction?

Research shows that peer support can improve health outcomes for people with chronic conditions, like diabetes, and may help in managing cardiovascular disease risks by encouraging healthy behaviors through collaborative goal-setting and action planning. ^{6 9 10 11 12}

Are You a Good Fit for This Trial?

The RePeAT trial is for English-speaking adults aged 40-75 who are patients at Highland Family Medicine, have limited health literacy, and a ≥10% risk of cardiovascular disease. They must plan to stay with the practice for at least a year and be able to consent.

Inclusion Criteria

My risk for cardiovascular disease is 10% or higher.

No plans to leave the practice in the next 12 months

Limited Health Literacy (self-report)

Exclusion Criteria

I have had a heart attack, stroke, or a procedure like stent placement.

I am unable to understand or make decisions about my treatment.

I have a condition affecting the blood flow to my limbs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peer Coaching

Participants in the experimental group have a brief discussion with a peer coach to prepare for shared decision-making in their next primary care appointment.

1 week

1 visit (virtual or in-person)

Patient-Clinician Office Visit

Participants attend their primary care appointment where the discussion about heart health goals is audio-recorded.

1 week after peer coaching

1 visit (in-person)

Follow-up

Participants are monitored for engagement in shared decision-making and the effectiveness of the peer coaching intervention.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peer Coach

Trial Overview This study tests if peer-coaches can help patients with low health literacy make informed decisions about reducing their risk of heart disease. It's about training peers to support these patients in understanding their choices.

How Is the Trial Designed?

Group I: Peer Coach Experimental Treatment 1 Intervention

The research coordinator will set up a time for the subject to have a brief discussion with a peer coach from the study team approximately 1 week after randomization. During the coaching session, the peer coach will encourage the subject to mention their heart health goals to their primary care clinician during their next primary care appointment. The peer coach will also help the subject brainstorm ways to remove any barriers that may prevent them from having the discussion with their clinician. The peer coaching session and the subsequent medical appointment will be audio-recorded.

Group II: Control Active Control 1 Intervention

The subject will not be asked to meet with the peer coach or anyone from the study team prior to their next visit with their primary care clinician. Their subsequent primary care appointment will be audio-recorded.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study involving 2,127 patients with cardiovascular risk showed that educational group interventions led by nurses saved time, with an average of 39.59 minutes of nurse dedication per patient in the intervention group compared to 60 minutes in the control group.

Despite the time savings, the intervention group experienced an increase in the number of visits and pharmaceutical expenditure, indicating that while group education may be efficient, it did not reduce overall healthcare resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of an educational group intervention in the control of patients with cardiovascular risk]. Puig-Girbau, MN., Lladó-Blanch, MM., Seco-Salcedo, MC., et al.[2011]

This study aims to evaluate a peer support intervention for improving hypertension control among 400 Veterans with poorly managed hypertension and additional cardiovascular risks, using a home-based approach with peer health coaches.

The trial will assess the effectiveness of this intervention by measuring changes in systolic blood pressure and cardiovascular disease risk, potentially providing valuable insights for community-based prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veteran peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH); design and rationale for a randomized controlled trial of peer support among Veterans with poorly controlled hypertension and other CVD risks. Nelson, K., Fennell, T., Gray, KE., et al.[2019]

Peer support can effectively enhance heart-healthy behaviors among women veterans at risk for cardiovascular disease, highlighting the importance of communal identity in health interventions.

Interviews with 25 women veterans revealed key factors for successful peer support, including shared goals, trust, compatibility in engagement levels, positivity, and accountability, suggesting that tailored peer matching and initial in-person interactions are crucial for building effective support relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding women veterans' preferences for peer support interventions to promote heart healthy behaviors: A qualitative study. Goldstein, KM., Zullig, LL., Oddone, EZ., et al.[2020]

Peer health coaching significantly lowers hemoglobin A1c (A1c) levels in patients with diabetes who have low self-management and medication adherence, indicating its effectiveness in high-risk groups.

In contrast, patients with high self-management and adherence showed similar improvements in A1c regardless of whether they received coaching or usual care, suggesting that coaching is particularly beneficial for those struggling with diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer coaching to improve diabetes self-management: which patients benefit most? Moskowitz, D., Thom, DH., Hessler, D., et al.[2022]

Linking a peer coach physical activity intervention to primary care resulted in only 5.7% participation from referred patients, but 66.7% of those who participated continued for a year, indicating strong retention among engaged individuals.

The study found that the number needed to refer to achieve one long-term participant in the program was 26.5, suggesting that this approach could be a feasible method to promote long-term physical activity in older adults with relatively low referral effort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking a peer coach physical activity intervention for older adults to a primary care referral scheme. van de Vijver, PL., Schalkwijk, FH., Numans, ME., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Technologically Enhanced Peer Support in Improving Glycemic Management Among Predominantly African American, Low-Income Adults With Diabetes. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

A pilot-study to identify the feasibility of an Internet-based coaching programme for changing the vascular risk profile of high-risk patients. [2015]

3. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of an educational group intervention in the control of patients with cardiovascular risk]. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Veteran peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH); design and rationale for a randomized controlled trial of peer support among Veterans with poorly controlled hypertension and other CVD risks. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Behavior-change action plans in primary care: a feasibility study of clinicians. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Trial to Encourage Adoption and Maintenance of a Mediterranean Diet (TEAM-MED): Protocol for a Randomised Feasibility Trial of a Peer Support Intervention for Dietary Behaviour Change in Adults at High Cardiovascular Disease Risk. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Understanding women veterans' preferences for peer support interventions to promote heart healthy behaviors: A qualitative study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Primary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The feasibility of a peer support intervention to encourage adoption and maintenance of a Mediterranean diet in established community groups at increased CVD risk: the TEAM-MED EXTEND study: a pilot cluster randomised controlled trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Peer coaching to improve diabetes self-management: which patients benefit most? [2022]

12. England pubmed.ncbi.nlm.nih.gov

Linking a peer coach physical activity intervention for older adults to a primary care referral scheme. [2023]