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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Days to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests Heartsight, an information program for caregivers of children who had a cardiac arrest, when the heart stops pumping blood. It will check whether the program is useful and easy to use, and whether it may reduce uncertainty, anxiety, depression, and stress after the event.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a caregiver of a child younger than 17½ years old.
  • You speak English.
  • Your child had a cardiac arrest lasting more than 2 minutes within the past 7 days.
  • Your child is still in a children's intensive care unit or a heart intensive care unit.
  • Your child is expected to leave the hospital within 30 days and live for at least 3 months after leaving.

Who can't join

  • A parent or legal guardian who is not the child's caregiver cannot join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Caregiver 1. 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. 2. English speaking Child 1. \<17.5 years of age 2. 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) Exclusion Criteria: 1\) Parent or legal guardian is not the child's caregiver

Study sites (1)

PA