Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Awards & highlights
HEARTPrep Trial Summary
This trial is developing a new psychosocial intervention to help reduce stress for moms of babies with CHD, potentially improving emotional wellbeing & developmental trajectories of these children.
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.Check my eligibility
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.See study design
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.
HEARTPrep Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English or Spanish fluently.
Select...
My unborn baby is diagnosed with a heart condition needing surgery within the first year.
Select...
I am 18 years old or older.
HEARTPrep Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Change in Hope - PROMIS Short-Form
HEARTPrep 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.
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.
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.
Find a Location
Who is running the clinical trial?
Nemours Children's ClinicLead Sponsor
125 Previous Clinical Trials
18,147 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Currently getting heart care for an unborn baby at Nemours Children's HealthI speak English or Spanish fluently.My unborn baby is diagnosed with a heart condition needing surgery within the first year.My unborn baby has been diagnosed with a condition that may limit life to under a year.I have a device with internet access.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: HEARTPrep
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger