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

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young adults with congenital heart disease by pairing them with someone who has successfully managed the same condition. This person will offer advice, support, and motivation to help them take better care of themselves and move to adult medical care.

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.

Is peer coaching safe for people with congenital heart disease?

Peer coaching, also known as peer support, has been studied in various contexts and is generally considered safe for people with chronic conditions, including those with congenital heart disease. Exercise programs, which can be part of peer coaching, have been shown to be safe for both adults and children with congenital heart disease. ^{1 2 3 4 5}

How does peer coaching for congenital heart disease differ from other treatments?

Peer coaching for congenital heart disease is unique because it focuses on promoting physical activity and enhancing self-confidence through a supportive, goal-oriented exercise program. Unlike traditional treatments that may focus solely on medical or surgical interventions, this approach emphasizes behavior change, motivation, and self-efficacy to improve overall fitness and quality of life. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Peer Health Coaching for Congenital Heart Disease?

The research on similar treatments, like e-Health encouragements for adolescents with congenital heart disease, suggests that interactive and motivational support can improve physical fitness and quality of life. This implies that peer health coaching, which also involves support and encouragement, might be effective in promoting better health outcomes for patients with congenital heart disease. ^{3 9 11 12 13}

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

Patient at an adult cardiology clinic

You have difficulty with thinking and understanding.

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Death and Emergency Readmission of Infants Discharged After Interventions for Congenital Heart Disease: A National Study of 7643 Infants to Inform Service Improvement. [2022]

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

Establishing a Comprehensive Pediatric Cardiac Fitness and Rehabilitation Program for Congenital Heart Disease. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Examining the Real-Life Journey of Individuals and Families Affected by Single-Ventricle Congenital Heart Disease. [2023]

4. United States 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. [2017]

5. United States 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? [2009]

6. Netherlands 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. [2019]

7. 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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise and training in adults with congenital heart disease. [2007]

9. United States 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. [2023]

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

Factors influencing adaptation and performance at physical exercise in complex congenital heart diseases after surgical repair. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Physical activity participation in youth with surgically corrected congenital heart disease: Devising guidelines so Johnny can participate. [2021]

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

Physical activity and congenital heart disease. [2005]

13. England pubmed.ncbi.nlm.nih.gov

Enablers and barriers for being physically active: experiences from adults with congenital heart disease. [2021]