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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT07707037
Status
Recruiting

Conditions

  • Anxiety Depression
  • Cardiac Arrest
  • Family Support

Eligibility Criteria

Sex
ALL
Age
0 Days - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Education Intervention — OTHER
    Caregivers will receive education modules at multiple time points during their children's post cardiac arrest recovery trajectory

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Jun 1, 2026
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Intervention
    Caregivers will receive cardiac arrest education intervention called Heartsight
  • No Intervention: Usual Care
    Patients and caregivers will receive usual care

Primary Outcome Measure

Retention Rate [ Time Frame: 3 months post enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Elizabeth Herrup, MD
215-514-0166

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