Removing Surrogates Uncertainty to Reduce Fear and Anxiety After Cardiac Events - Kids

NCT07707037 | Recruiting

• 1 other identifier: 26-024333
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized controlled trial (RCT) will test the feasibility and acceptability of the informational intervention program, Heartsight, to reduce caregivers' uncertainty experienced throughout their child's illness trajectory after cardiac arrest. The investigator aims to enroll up to 30 caregivers of pediatric cardiac arrest patients to (Aim 1a) pilot recruitment and randomization (2:1) procedures, and (Aim 1b) estimate retention rate at 3 months and assess engagement and utilization metrics for frequency of access and time spent on each module of the informational packages. The investigator also aims to evaluate the association of the intervention with efficacy outcomes in an exploratory manner in preparation for a larger trial, including (Aim2a) a preliminary estimate of the association of intervention with the surrogate's uncertainty levels at 3 months post-discharge, and (Aim 2b) a preliminary estimate of the association of intervention with the surrogate's anxiety, depression, and post-traumatic stress symptoms at 3 months post-discharge.

Conditions

Cardiac Arrest; Anxiety Depression; Family Support

Outcome Measures

Primary Outcomes (1)

• Retention Rate

  Proportion of enrolled caregivers who complete the study requirements

  3 months post enrollment

Secondary Outcomes (4)

• Depression Screen as Measured by the Patient Health Questionnaire-4

  Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.

• Anxiety Screen as Measured by the Patient Health Questionnaire-4

  Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.

• Presence and Severity of Post Traumatic Stress Disorder Symptoms as Measured by the Posttraumatic Stress Disorder Checklist (PCL-5)

  Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.

• Uncertainty regarding a child's medical diagnosis, treatment, or health condition as measured by Parents' Perception of Uncertainty Scale (PPUS)

  Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.

Study Arms (2)

Intervention

OTHER

Caregivers will receive cardiac arrest education intervention called Heartsight

Other: Education Intervention

Usual Care

NO INTERVENTION

Patients and caregivers will receive usual care

Interventions

Education Intervention OTHER

Caregivers will receive education modules at multiple time points during their children's post cardiac arrest recovery trajectory

Intervention

Eligibility Criteria

• Age: 0 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caregiver
• Caregiver of a child \<17.5 years of age who had at least a 2 minute cardiac arrest, is expected to be discharged within 30 days, and to survive at least 3 months post-discharge from hospital.
• English speaking
• Child
• \<17.5 years of age
• Have had a cardiac arrest lasting more than 2 minutes within the past 7 days and have not yet been discharged from pediatric intensive care unit (PICU) or cardiac intensive care unit (CICU)

You may not qualify if:

• \) Parent or legal guardian is not the child's caregiver

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Central Study Contacts

Elizabeth Herrup, MD

CONTACT

215-514-0166; herrupe@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)