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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a peer coach can assist patients with limited health literacy in discussing heart disease risk reduction with their doctors. Participants will either meet with a peer coach or continue their usual care without one. The peer coach will support patients in discussing heart health goals and overcoming barriers to these conversations. This trial suits English-speaking patients of Highland Family Medicine who are at risk for heart disease, have limited health literacy, and have not experienced a heart event. As an unphased trial, it offers a unique opportunity for patients to actively improve their heart health communication skills.

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.

What prior data suggests that this peer coaching method is safe for patients with limited health literacy?

Research shows that peer coaching can be safe and helpful for people with heart disease. Studies have found that peer support improves health for those with conditions like diabetes and may also aid those with heart disease. For instance, one study found that peer coaching lowered blood pressure by 5 mm Hg in people under 60, benefiting heart health. Another study showed that joining a coaching program reduced the risk of death by 34% for people with heart conditions.

These findings suggest that peer coaching is generally well-tolerated and can enhance heart health. So far, no evidence indicates serious safety concerns with peer coaching. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how peer coaching can be used to reduce cardiovascular disease risk. Unlike traditional treatments that may focus on medications or lifestyle changes advised by clinicians, this approach involves personalized support from someone who shares similar experiences. The peer coach encourages patients to actively discuss their heart health goals with their doctors, potentially leading to more tailored and effective care. This method could empower patients and improve communication with healthcare providers, offering a fresh perspective on managing heart health.

What evidence suggests that peer coaching is effective for cardiovascular disease risk reduction?

Research has shown that peer coaching can greatly improve health for people at risk of heart disease. For instance, one study found that joining The COACH Program linked participants to a 34% lower risk of death. Another study demonstrated that peer health coaching helped veterans with several heart disease risk factors achieve better health. In general, peer support has been shown to assist patients with long-term health issues by promoting healthier habits and encouraging collaborative decision-making with their doctors. In this trial, participants in the Peer Coach arm will have a brief discussion with a peer coach to help them address heart health goals. These findings suggest that peer coaching can be a useful way to lower the risk of heart disease. ^{2 6 7 8 9}

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

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10245194/

Effect of a Peer Health Coaching Intervention on Clinical ... To test the effectiveness of a home-visit, peer health coaching intervention to improve health outcomes for veterans with multiple CVD risks.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2805604

Effect of a Peer Health Coaching Intervention on Clinical ... Peer support has been shown to improve health outcomes for patients with chronic conditions; however, there is less evidence for chronic disease ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667036424000128

Coaching People with Cardiovascular Disease to Close ... Participation in The COACH Program was associated with a 34% reduction in the risk of mortality (HR: 0.66, 95% CI: 0.54, 0.79), an 8% reduction in the number of ...

4. withpower.com withpower.com/trial/phase-cardiovascular-diseases-8-2021-38751

Peer Coaching for Cardiovascular Disease Risk Reduction ... 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 ...

5. annalsofglobalhealth.org annalsofglobalhealth.org/articles/10.5334/aogh.2496

Personalized E-Coaching in Cardiovascular Risk Reduction Primary outcome data were available for 94%. There was no difference in PWV reductions between e-coaching and standard of care groups (–0.16 m/s ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11513497/

Coaching People with Cardiovascular Disease to Close ... Participation in The COACH Program was associated with a 34% reduction in the risk of mortality (HR: 0.66, 95% CI: 0.54, 0.79), an 8% reduction ...

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2816426

Practice Facilitation and Peer Coaching for Uncontrolled ... Peer coaching significantly lowered systolic blood pressure in people younger than 60 years by 5 mm Hg. Meaning Peer coaching can help younger ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02697422

Study Details | NCT02697422 | Veteran Peer Coaches ... Secondary outcomes include a reduction in Framingham Cardiovascular risk score, individual cardiovascular risks (tobacco use, lipids), health related quality of ...

9. ahajournals.org ahajournals.org/doi/10.1161/circoutcomes.111.961573

Community Outreach and Cardiovascular Health (COACH) ... A randomized, controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers.