HEARTPrep for Congenital Heart Disease

(HEARTPrep Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Genetic syndrome, Life expectancy <1 year

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called HEARTPrep, designed to assist mothers expecting a baby with congenital heart disease (CHD). CHD is a heart defect present from birth, and receiving this diagnosis during pregnancy can be very stressful for mothers. HEARTPrep is a virtual intervention program with modules focused on reducing emotional distress, decreasing feelings of social isolation, and boosting parenting confidence. It specifically targets expectant mothers whose babies will need heart surgery in their first year. Participants should receive care at Nemours Children's Health and speak either English or Spanish fluently. As an unphased trial, this study offers a unique opportunity to contribute to innovative support strategies for expectant mothers facing CHD challenges.

Will I have to stop taking my current medications?

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

What prior data suggests that HEARTPrep is safe for mothers expecting a baby with CHD?

Research shows that HEARTPrep is a digital program designed to support mothers expecting a baby with congenital heart disease (CHD). It helps reduce stress, lessen feelings of isolation, and boost parenting confidence. While specific safety data for HEARTPrep is unavailable, it is important to note that this program provides psychosocial support. This involves activities like talking with a counselor, watching videos, and using educational tools, rather than taking medicine or undergoing medical procedures.

Psychosocial support is generally safe and focuses on improving mental and emotional well-being. Delivered through telehealth and mobile apps, HEARTPrep is non-invasive and avoids the risks associated with physical treatments. This suggests it is likely well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

HEARTPrep is unique because it is a virtually-delivered psychosocial intervention specifically designed for mothers expecting babies with congenital heart disease (CHD). Unlike traditional support options that may involve in-person therapy or support groups, HEARTPrep uses telehealth sessions, recorded videos, and educational tools to provide convenient access to emotional and social support. Researchers are excited about HEARTPrep because it targets emotional distress, social isolation, and parenting self-efficacy, while also boosting hope, using evidence-based methods like psychoeducation and mindfulness. This comprehensive, accessible approach can make a significant difference for mothers navigating the challenges of a CHD diagnosis during pregnancy.

What evidence suggests that HEARTPrep is effective for improving emotional wellbeing in mothers expecting a baby with CHD?

Research has shown that HEARTPrep, an online support program, may assist mothers expecting a baby with congenital heart disease (CHD). Early results suggest that participants find HEARTPrep easy to use and enjoyable. The program aims to reduce stress and feelings of isolation while boosting parenting confidence. It offers education, mindfulness, and support through online health services. Although further research is needed, initial signs indicate it could enhance emotional well-being and potentially benefit the health and development of children with CHD. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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

Partners of participating expectant mothers can also participate together with the mother

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• HEARTPrep

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10898312/

User-Centered Development of HEARTPrep, a Digital ... This study used a five-phase, user-centered approach to develop HEARTPrep, a psychosocial intervention delivered via mobile app and telehealth to mothers.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05129631

Study Details | NCT05129631 | HEARTPrep: A Virtually- ... This intervention has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10758983/

Feasibility and acceptability of HEARTPrep - PMC HEARTPrep is feasible and acceptable for mothers expecting a baby with CHD. Future research will evaluate its efficacy in preventing/reducing maternal mental ...

4. ctv.veeva.com ctv.veeva.com/study/heartprep-a-virtually-delivered-psychosocial-intervention-for-mothers-expecting-a-baby-with-congeni

HEARTPrep: A Virtually-delivered Psychosocial Intervention ... This project will pilot HEARTPrep with mothers expecting a baby with CHD to obtain preliminary data for a larger future trial. This intervention ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840527

Digital Emotion Regulation Interventions for Patients With ... Patient-reported outcomes among adults with congenital heart disease in the Congenital Heart Initiative registry.  JAMA Netw Open. 2024;7 ...

6. withpower.com withpower.com/trial/phase-heart-diseases-2022-c20eb

HEARTPrep for Congenital Heart Disease The available research does not provide specific safety data for HEARTPrep, but it does discuss the safety of cardiac catheterization procedures for congenital ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37355506/

Feasibility and Acceptability of HEARTPrep - PubMed - NIH HEARTPrep is a virtually delivered psychosocial intervention aimed at reducing distress and social isolation and increasing parenting self-efficacy and hope.

8. researchgate.net researchgate.net/publication/378542129_User-Centered_Development_of_HEARTPrep_a_Digital_Health_Psychosocial_Intervention_for_Prenatally_Diagnosed_Congenital_Heart_Disease

(PDF) User-Centered Development of HEARTPrep, a ... User-Centered Development of HEARTPrep, a Digital Health Psychosocial Intervention for Prenatally Diagnosed Congenital Heart Disease. SAGE Publications Inc.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38414756/

User-Centered Development of HEARTPrep, a Digital Health ... This study used a five-phase, user-centered approach to develop HEARTPrep, a psychosocial intervention delivered via mobile app and telehealth to mothers.