Virtual support for mothers expecting babies with congenital heart disease
HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
This study is testing a virtual support program for mothers expecting babies with congenital heart disease to see if it can help reduce their stress and improve their emotional wellbeing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Wilmington, Delaware) |
| Trial ID | NCT05129631 on ClinicalTrials.gov |
What this trial studies
HEARTPrep is a virtually-delivered psychosocial intervention designed to support mothers who are expecting a baby diagnosed with congenital heart disease (CHD). This program aims to alleviate the high levels of stress and trauma that mothers experience following a CHD diagnosis, which can negatively impact both maternal wellbeing and child development. Delivered through the Nemours App, HEARTPrep includes various modules that focus on improving emotional health and resilience. The pilot program will gather preliminary data to inform a larger future trial assessing its effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are expectant mothers carrying a fetus with congenital heart disease who are receiving care at Nemours Children's Health.
Not a fit: Patients whose fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the emotional wellbeing of mothers, leading to better developmental outcomes for their children.
How similar studies have performed: While psychosocial interventions for expectant mothers are not widely tested in this specific context, similar approaches have shown promise in improving maternal and child health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life * Partners of participating expectant mothers can also participate together with the mother * Receiving fetal cardiac care at Nemours Children's Health * Speaks English or Spanish fluently * Age 18 or older * Access to a computer, tablet or mobile device with internet access Exclusion Criteria: -Fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year
Where this trial is running
Wilmington, Delaware
- Nemours Children's Health — Wilmington, Delaware, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.