Peer Coaching for Congenital Heart Disease

(CHASM in ACHD Trial)

Overseen By Jodie L Neukirch Elliott, MSW

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive delay, Adult cardiology patient

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if peer coaching can help young adults with congenital heart disease manage their condition more effectively. Participants will either receive regular educational newsletters or participate in a peer coaching program for six months. Those between 18 and 26, with congenital heart disease, and who are patients at a Duke pediatric cardiology clinic may qualify. Participants must also have access to a smartphone.

As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance support for managing congenital heart disease.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this peer coaching intervention is safe for young adults with congenital heart disease?

Research has shown that peer coaching, including exercise programs, is safe for adults and children with congenital heart disease. These programs assist individuals in managing their condition. Although a recent study on a similar peer health coaching program did not demonstrate a significant reduction in systolic blood pressure (the top number in a blood pressure reading), participants reported an overall improvement in well-being. No reports of serious side effects from peer coaching exist, making it a well-tolerated option for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about peer health coaching for congenital heart disease because it offers a unique, personalized approach that current treatments don't provide. Unlike traditional medical care that focuses primarily on medication and surgical interventions, peer coaching involves support from individuals who have firsthand experience with the condition. This method can enhance emotional well-being and empower patients through shared experiences and support. By fostering a supportive community, peer coaching aims to improve patients' quality of life and adherence to medical advice, something standard treatments might not fully address.

What evidence suggests that peer health coaching is effective for congenital heart disease?

Research has shown that peer health coaching can benefit people with congenital heart disease. This trial includes a Peer Coaching arm, where participants receive a 6-month peer health coaching intervention. This method pairs individuals with peers who have successfully managed similar health issues. Other studies have found that health coaching slightly but significantly improves health outcomes, such as blood sugar levels. Although specific data for congenital heart disease is limited, participants often report a better quality of life after receiving coaching. Early findings suggest that peer coaching could help young adults transition more smoothly to adult heart care. ^{1 2 3 6 7}

Who Is on the Research Team?

Richard A Krasuski, MD

Principal Investigator

Duke University

Gary Maslow, MD, MPH

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-26 with congenital heart disease who are patients at a Duke pediatric cardiology clinic and have access to a smartphone. It's not suitable for individuals with cognitive delays or those attending an adult cardiology clinic.

Inclusion Criteria

You have a smartphone.

Patient at a Duke pediatric cardiology clinic

I was born with a heart condition.

Exclusion Criteria

You have difficulty with thinking and understanding.

Patient at an adult cardiology clinic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 2 months

Treatment

Participants receive a 6-month peer health coaching intervention or education-only material

6 months

Biweekly interactions

Follow-up

Participants are monitored for changes in health-related quality of life, patient activation, self-management, and transition readiness

Up to 8 months

Long-term follow-up

Evaluate successful transfer of participants from pediatric to adult cardiology care

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Peer Health Coaching

Trial Overview The study is looking into the effectiveness of peer health coaching as an intervention for young adults with congenital heart disease, aiming to improve their health outcomes and self-management skills.

How Is the Trial Designed?

Group I: Peer Coaching Experimental Treatment 1 Intervention

Participant receive a 6 month peer health coaching intervention.

Group II: Education only Active Control 1 Intervention

Participants receive education-only material (newsletter) biweekly for 6 months

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Adult Congenital Heart Association

Collaborator

Trials

2

Recruited

80+

Published Research Related to This Trial

Adults with complex congenital heart disease often face barriers to physical activity, such as lack of encouragement during childhood, which can lead to negative attitudes towards exercise in adulthood.

Identifying enablers, like support and knowledge about their exercise capacity, is crucial for healthcare professionals to help these individuals engage in physical activity safely and effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enablers and barriers for being physically active: experiences from adults with congenital heart disease. Bay, A., Lämås, K., Berghammer, M., et al.[2021]

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]

Youth with congenital heart disease, especially those with complex defects, face significant health challenges, but engaging in physical activity can improve their quality of life.

Despite the known benefits of exercise, many young patients have low participation levels and self-efficacy, which increases their risk of obesity and cardiovascular issues, highlighting the need for tailored rehabilitation programs and advocacy for safe physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity participation in youth with surgically corrected congenital heart disease: Devising guidelines so Johnny can participate. Moola, F., McCrindle, BW., Longmuir, PE.[2021]

This study involves 216 adolescents aged 13-16 with surgically corrected congenital heart disease, testing the impact of a year-long e-Health intervention on their physical fitness and quality of life.

The intervention includes weekly tailored encouragements via SMS and mobile apps, aiming to enhance physical activity, with the hypothesis that it will improve fitness levels measured by maximal oxygen uptake (Vo2) after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and rationale for the PREVAIL study: effect of e-Health individually tailored encouragements to physical exercise on aerobic fitness among adolescents with congenital heart disease--a randomized clinical trial. Klausen, SH., Mikkelsen, UR., Hirth, A., et al.[2017]

Patients with congenital heart disease are at risk for being overweight and having low physical activity, making lifestyle measures crucial for their health.

Exercise testing is primarily used to ensure safety during physical activity, and systematic training programs have been shown to be safe for small groups of these patients, although data on their effects are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and training in adults with congenital heart disease. Thaulow, E., Fredriksen, PM.[2007]

A study involving 40 adults with moderate to severe congenital heart disease showed that home-based, self-selected exercise training is safe and well-tolerated, with no participants discontinuing due to exercise-related issues.

Participants who engaged in the exercise program experienced a significant improvement in their exercise capacity, as indicated by a 1.7 ml∙kg∙min-1 increase in peak VO2, while the control group showed no significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of home-based, self-selected exercise training in symptomatic adults with congenital heart disease: A prospective, randomised, controlled trial. van Dissel, AC., Blok, IM., Hooglugt, JQ., et al.[2019]

A comprehensive 'Cardiac Fitness Program' was developed at Boston Children's Hospital to promote exercise and self-confidence in children and adolescents with congenital heart disease, focusing on optimal fitness rather than rehabilitation.

The program includes a progressive exercise curriculum, a self-learning workbook, a motivational app, and instructional videos, aiming to encourage consistent participation and behavior change in physical activity among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a Comprehensive Pediatric Cardiac Fitness and Rehabilitation Program for Congenital Heart Disease. Gauthier, N., Curran, T., O'Neill, JA., et al.[2020]

Exercise training is safe for children and adolescents with congenital heart disease, with no reported adverse events linked to the interventions across 6 trials involving 642 participants.

The training showed efficacy in improving physical fitness, with significant enhancements in exercise capacity and cardiorespiratory fitness in several studies, although the evidence quality is considered low to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of exercise training in children and adolescents with congenital heart disease: A systematic review and descriptive analysis. Anderson, CAJ., Suna, JM., Keating, SE., et al.[2023]

The literature review identified only 16 articles on self-help groups for cardiovascular heart disease (CHD), indicating a significant lack of research on their effectiveness in rehabilitation and self-management.

Current studies on CHD-related self-help groups are limited in quantity and quality, making it difficult to draw reliable conclusions about their impact and the reasons for patient participation or nonparticipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-help groups for patients with coronary heart disease as a resource for rehabilitation and secondary prevention-what is the evidence? Jackson, AM., Gregory, S., McKinstry, B.[2009]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04271358

Peer Coaching Intervention in Young Adults With ... This pilot study will test feasibility and acceptability, as well as preliminary efficacy and long-term effects on successful transfer to adult cardiology.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK487705/

RESULTS - The Effectiveness of Health Coaching - NCBI Health coaching demonstrated a small, positive, statistically significant effect on change in HbA1c (-0.30; 95% CI -0.50 to -0.10) compared with an inactive ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824913

Patient-Reported Outcomes Among Adults With Congenital ... Most patients (2882 participants [84%]) reported a good or better health-related quality of life, regardless of CHD complexity (χ2 = 0.54; P = .

4. withpower.com withpower.com/trial/phase-heart-diseases-9-2020-08a9a

Peer Coaching for Congenital Heart Disease ... This trial aims to help young adults with congenital heart disease by pairing them with someone who has successfully managed the same condition.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772812925000466

Virtual Peer Mentoring for Adolescents With Congenital ... Study results demonstrated a participant accrual rate of 25% (19 of 76) and an enrollment rate of 95% (18 of 19). Eighteen adolescents (mean age ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37278999/

Effect of a Peer Health Coaching Intervention on Clinical ... This trial found that, although the peer health coaching program did not significantly decrease SBP, participants who received the intervention reported better ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.118.009450

Public Health Approach to Improve Outcomes for ... Emerging data suggest that older individuals with CHD are at increased risk for mortality, driven by coronary artery disease, heart failure, and ...