What is the mechanism of action of this treatment?

Common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and medications to manage symptoms and improve heart function. However, multidisciplinary care and psychological support, such as peer coaching, play a critical role in the overall treatment plan. These approaches help patients cope with the emotional and social challenges of living with CHD, improving their quality of life and mental health. This holistic care is essential for long-term management and recovery, ensuring that patients receive comprehensive support beyond just the physical aspects of the disease.

What side effects are associated with this type of intervention?

Psychological and social support interventions, such as peer coaching, generally have minimal physical side effects but can vary in effectiveness based on individual engagement and the quality of the support provided. Common medical treatments for CHD, such as medications and surgical interventions, can have side effects including infection, bleeding, arrhythmias, and reactions to anesthesia. It's important for patients to discuss potential side effects with their healthcare provider to make informed decisions.

What prior FDA approvals exist?

The FDA has approved various treatments for Congenital Heart Disease (CHD), primarily focusing on medical devices and pharmacological interventions. These include cardiac assist devices and medications like sildenafil for managing pulmonary hypertension associated with CHD. While there are no specific FDA approvals for psychological or social support treatments for CHD, such as peer coaching, these supportive interventions are recognized as valuable for improving the overall well-being and quality of life of patients with CHD.

What other types of research exist?

Promising, novel alternatives to peer coaching for congenital heart disease patients include: 1) Cognitive Behavioral Therapy (CBT), which has been effective in managing anxiety and depression; 2) Music Therapy, which can improve emotional well-being and social interaction; 3) Therapeutic Horseback Riding, which has shown benefits in social functioning and emotional regulation; and 4) Technology-based interventions, such as mobile health apps and telehealth services, which provide remote psychological support and monitoring.

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Peer Coaching for Congenital Heart Disease (CHASM in ACHD Trial)

N/A

Waitlist Available

Led By Richard A Krasuski, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-26

Diagnosis of congenital heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves peer coaching rather than medication, there aren't typical medical side effects. However, participants may experience emotional or psychological impacts from discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 26 years old.

Select...

I was born with a heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine change in patient activation

Determine change in self-management

Evaluate completion of study

+2 more

Secondary study objectives

Determine change in emotional health

Determine change in health related quality of life

Determine change in transition readiness

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peer CoachingExperimental Treatment1 Intervention

Participant receive a 6 month peer health coaching intervention.

Group II: Education onlyActive Control1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and medications to manage symptoms and improve heart function. However, multidisciplinary care and psychological support, such as peer coaching, play a critical role in the overall treatment plan. These approaches help patients cope with the emotional and social challenges of living with CHD, improving their quality of life and mental health. This holistic care is essential for long-term management and recovery, ensuring that patients receive comprehensive support beyond just the physical aspects of the disease.

[Surgery of complex congenital cardiopathies].