Support Tool for Families of High-Risk Children With Heart Disease During Hospital Admission and After Discharge

NCT05926661 | Withdrawn

• 2 other identifiers: Support ToolsU54GM104941-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to pilot the "support tool" in the Nemours Cardiac Center to assess acceptability and feasibility. This tool will be offered to 5 high-risk families, and they will be asked to complete a survey. In addition, healthcare providers including bed-side nurses and cardiologists will be asked to complete a survey to assess the feasibility of the tool.

Conditions

Heart Disease Congenital

Outcome Measures

Primary Outcomes (2)

• Acceptability of support tool

  By administering surveys to 5 families

  12 weeks

• Feasibility of support tool

  By administering surveys to the bed-side nurses and cardiologists.

  12 weeks

Study Arms (1)

Parent/Caregiver of high-risk children with heart disease

OTHER

The parent/caregivers of high-risk children with heart disease coming to the Nemours Cardiac Center for care will be offered a "support tool" and will be asked for it's acceptance and feasibility through their experience.

Other: NCC Support Toolkit

Interventions

NCC Support Toolkit OTHER

Pre-discharge intervention- * Set expectations for parents/caregivers to spend time bedside and attend rounds * iPad for the families to use the Nemours App, download education materials and Facetime communication with medical personnel. * Download Nemours App and teach them how to use it * Education materials- to ease the use of medications, Oxygen and feeding * Assistance with transportation, child care, parental work schedule for discharge teaching Post Discharge intervention (Day 1-2): • Video/Facetime call with the family to check equipment, home environment and answer questions about medications and formula Post discharge intervention (Day 3-7): • Phone call to the family to ensure transportation for their first follow-up appointment, answer questions about medications, Oxygen and feeding.

Parent/Caregiver of high-risk children with heart disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents of a child with congenital heart disease and planned discharge from the Nemours Cardiac Center.

You may not qualify if:

• Non-English and Non-Spanish speaking families.
• The Healthcare providers group is pre-identified and they will be invited to provide feedback through semi-structured qualitative interviews only. They will not receive any intervention. Their participation will be voluntary.

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Nemours Children's Hospital

Wilmington, Delaware, 19803, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Deepika Thacker, MD

  Nemours Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiologist

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 3, 2023
• Study Start: November 29, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)