HEARTPrep for Congenital Heart Disease

(HEARTPrep Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nemours Children's Clinic

Disqualifiers: Genetic syndrome, Life expectancy <1 year

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

Is HEARTPrep safe for humans?

The available research does not provide specific safety data for HEARTPrep, but it does discuss the safety of cardiac catheterization procedures for congenital heart disease, showing a 4.1% rate of significant adverse events in a large study. This suggests that while there are risks, they are relatively low in this context. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Currently getting heart care for an unborn baby at Nemours Children's Health

I speak English or Spanish fluently.

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

Exclusion Criteria

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the HEARTPrep intervention, which includes modules on Adjusting, Connecting, and Preparing, delivered virtually through the Nemours App.

12 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for changes in emotional distress, social isolation, hope, and parenting self-efficacy after the intervention.

4 weeks

Treatment Details

Interventions

• HEARTPrep (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: HEARTPrep Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

R. Lawrence Moss

Nemours Children's Clinic

Chief Executive Officer since 2018

MD, FACS, FAAP

Matthew Davis

Nemours Children's Clinic

Chief Medical Officer since 2023

MD, MAPP

Findings from Research

The PREDIC3T risk metric effectively categorizes procedural risk in congenital cardiac catheterization, with a significant association between higher risk categories and increased rates of significant adverse events (SAE), as demonstrated in a study of 64,419 cases over 14 years.

The study found that the odds of experiencing an SAE increased with higher PREDIC3T risk categories, indicating that this classification tool can help predict and manage procedural risks in congenital heart procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of PREDIC3T Case Type Risk Category in the CRISP Registry. Kobayashi, D., Amin, EK., Morgan, GJ., et al.[2023]

In a study of 10,885 cardiac catheterizations for congenital heart disease, operators with less than 5 years of experience had significantly higher rates of adverse events (AEs), including preventable AEs, compared to those with 5 to less than 25 years of experience.

Operators with less than 5 years in practice were also more likely to cause vascular or cardiac trauma and technical AEs, highlighting the importance of experience in reducing procedural risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between procedural adverse events associated with cardiac catheterization for congenital heart disease and operator factors: results of a multi-institutional registry (C3PO). Holzer, RJ., Gauvreau, K., Kreutzer, J., et al.[2013]

In a study of 8,905 congenital and pediatric cardiac catheterization cases, the overall incidence of life-threatening events was found to be low at 2.1%, with a mortality rate of only 0.28%.

Key risk factors for life-threatening events included being under 1 year of age, having hemodynamic vulnerability, and undergoing higher-risk procedures, which can help in preprocedural planning and emergency preparedness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and management of life-threatening adverse events during cardiac catheterization for congenital heart disease. Lin, CH., Hegde, S., Marshall, AC., et al.[2021]

In a study of 458 adults with congenital heart disease undergoing cardiac surgery, the overall mortality rate was low at 3.49%, but significant risk factors for mortality included a history of cerebrovascular disease and higher NYHA functional class (3 or 4).

Major adverse events occurred in 20.5% of patients, with risk factors including male gender, higher NYHA class, and prolonged cardiopulmonary bypass time, indicating that awareness and management of these factors could enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery in adults with congenital heart disease: risk factors for morbidity and mortality. Kogon, B., Grudziak, J., Sahu, A., et al.[2013]

Machine learning (ML) can effectively predict major adverse cardiovascular events (MACEs) in patients with repaired tetralogy of Fallot (rTOF), achieving a similar predictive accuracy to experienced clinical experts, with an area under the curve (AUC) of 0.85 compared to 0.92 for expert assessments.

For clinicians with less than 20 years of experience, incorporating ML into their risk assessments significantly improved their predictive capabilities, suggesting that ML can provide valuable support in clinical decision-making for rTOF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incremental value of machine learning for risk prediction in tetralogy of Fallot. Ishikita, A., McIntosh, C., Roche, SL., et al.[2023]

References

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

Usefulness of PREDIC3T Case Type Risk Category in the CRISP Registry. [2023]

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

Relationship between procedural adverse events associated with cardiac catheterization for congenital heart disease and operator factors: results of a multi-institutional registry (C3PO). [2013]

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

Incidence and management of life-threatening adverse events during cardiac catheterization for congenital heart disease. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Surgery in adults with congenital heart disease: risk factors for morbidity and mortality. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Incremental value of machine learning for risk prediction in tetralogy of Fallot. [2023]