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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

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 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.

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

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

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 more

Secondary 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

18,111 Total Patients Enrolled

Media Library

HEARTPrep (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05129631 — N/A

Congenital Heart Disease Research Study Groups: HEARTPrep

Congenital Heart Disease Clinical Trial 2023: HEARTPrep Highlights & Side Effects. Trial Name: NCT05129631 — N/A

HEARTPrep (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05129631 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications available for this experiment in medical treatments?

"Indeed, according to clinicaltrials.gov the trial is currently accepting applicants with 20 people needed from one site. This medical study was initiated on July 14th 2023 and has been modified recently; the last update being made on August 9th 2023."

Answered by AI

What is the scope of participants being evaluated as part of this trial?

"Affirmative. Records on clinicaltrials.gov demonstrate that this investigation is actively recruiting participants, which commenced advertising for volunteers on July 14th 2023 and was most recently edited on August 9th 2023. The trial needs to acquire 20 patients from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease

Erica Sood 2023. "HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05129631.

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