What side effects are associated with this type of intervention?

Common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and medication. Surgical treatments can lead to side effects such as infection, bleeding, and arrhythmias. Catheter-based procedures may cause bruising, bleeding, or damage to blood vessels. Medications used to manage CHD can have side effects like gastrointestinal issues, dizziness, and fatigue. Psychosocial support interventions, such as those studied in the HEARTPrep trial, generally have minimal physical side effects but can vary in effectiveness and may require ongoing participation to maintain benefits.

What prior FDA approvals exist?

The FDA has approved various treatments for Congenital Heart Disease (CHD), primarily focusing on surgical interventions and medical devices to correct structural heart defects. These include transcatheter devices for closing septal defects and stents for managing coarctation of the aorta. While there are no specific FDA-approved psychosocial support treatments for reducing maternal stress in the context of CHD, interventions like HEARTPrep are innovative approaches aimed at improving maternal emotional wellbeing, which can positively influence outcomes for both mothers and their children with CHD.

What other types of research exist?

Promising alternatives to HEARTPrep for reducing maternal stress in CHD patients include: 1) Virtual reality (VR) and augmented reality (AR) programs designed to provide immersive stress-relief experiences. 2) Telehealth-based cognitive-behavioral therapy (CBT) tailored for expectant mothers. 3) Mobile health (mHealth) applications offering guided meditation, mindfulness exercises, and peer support networks. 4) Comprehensive prenatal education programs that include stress management techniques and emotional support. 5) Integrative approaches combining traditional psychosocial support with complementary therapies such as yoga, acupuncture, and expressive arts therapy.

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Behavioral Intervention

HEARTPrep for Congenital Heart Disease (HEARTPrep Trial)

N/A

Recruiting

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

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

Must have

Speaks English or Spanish fluently

Expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life

Must not have

Fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Awards & highlights

Summary

This trial tests HEARTPrep, a virtual support program for pregnant women expecting a baby with congenital heart disease (CHD). The program aims to reduce stress and improve emotional wellbeing, potentially leading to better health outcomes for both mothers and their babies.

Who is the study for?

This trial is for expectant mothers aged 18 or older, fluent in English or Spanish, who are carrying a baby diagnosed with congenital heart disease needing surgery within the first year. They must have internet access and be receiving care at Nemours Children's Health. Partners can join if participating together with the mother.

What is being tested?

HEARTPrep is being tested; it's a virtual support program designed to help expectant mothers cope with the stress of having a baby diagnosed with congenital heart disease. The goal is to improve maternal wellbeing and potentially benefit child development.

What are the potential side effects?

Since HEARTPrep is a psychosocial intervention delivered virtually, there are no direct physical side effects like those associated with medications or surgeries.

Eligibility Criteria

Inclusion Criteria

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

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I speak English or Spanish fluently.

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My unborn baby is diagnosed with a heart condition needing surgery within the first year.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My unborn baby has been diagnosed with a condition that may limit life to under a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Emotional Distress - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form

Change in Parenting Self-Efficacy - PROMIS Short-Form

Change in Social Isolation - PROMIS Short-Form

+2 more

Secondary study objectives

Change in Hope - PROMIS Short-Form

Trial Design

1Treatment groups

Experimental Treatment

Group I: HEARTPrepExperimental Treatment1 Intervention

HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep consists of three distinct modules: Adjusting, Connecting, and Preparing. Each module targets one distinct primary outcome (emotional distress, social isolation, parenting self-efficacy) and a common secondary outcome (hope) through a suite of evidence-based intervention elements (e.g., psychoeducation, cognitive restructuring, mindfulness) for addressing emotional problems in other populations, including pregnant women. HEARTPrep elements include: a) telehealth with a psychosocial provider, b) recorded videos, c) educational tools, and d) links to resources.

0 / 4Eligibility 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 procedures to correct structural defects, medications to manage symptoms and prevent complications, and the use of devices like implantable cardioverter defibrillators. Additionally, psychosocial interventions such as the HEARTPrep program focus on reducing maternal stress, which is vital as maternal stress can negatively impact both maternal and child health outcomes. By addressing the emotional and psychological well-being of mothers, these interventions can improve developmental trajectories and overall health outcomes for children with CHD.

Medical treatment of pulmonary hypertension in adults with congenital heart disease: updated and extended results from the International COMPERA-CHD Registry.Contemporary management of pediatric heart failure.