N/A
N=16
Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear)
Cardiac Arrest · Post Traumatic Stress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05144477 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study — 16; 4; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FAID Fear Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study |
16; 4; 5 | — |
| PRIMARY Proportion of Enrolled Family Members Who Complete the Pilot Study |
14; 2 | — |
| SECONDARY Proportion of Family Members That Adhere to the Diary Intervention |
7; 4 | — |
| SECONDARY Proportion of Family Members That Complete the Majority of Survey Assessments |
14; 2 | — |
| SECONDARY Proportion of Family Members That Agree That the Intervention Was Acceptable |
8; 2 | — |
| SECONDARY Proportion of Family Members That Agree That the Intervention Was Feasible |
9; 1 | — |
| SECONDARY Proportion of Family Members That Agree That the Intervention Was Appropriate |
7; 3 | — |
Summary
The present study will:
Aim 1: Enroll 15 family members of CA patients to (a) pilot recruitment procedures, (b) estimate retention, and (c) assess acceptability of study procedures.
Family members will be randomized to either complete an ICU diary or to a control condition, and will complete surveys in the ICU, at patient discharge, and 30 days post-discharge.
Aim 2: Obtain an estimate of the association of intervention v. control with (i) family member fear (operationalized as cardiac anxiety about the patients' cardiac condition) at hospital discharge and (ii) family member PTSS 30 days post-discharge.
Exploratory Aims: Obtain an estimate of the association of intervention v. control with family member aversive cognitions towards exercise at hospital discharge.
Eligibility Criteria
Inclusion Criteria
- The family member of a patient who has experienced a cardiac arrest
- Age 18 years and over
- Able to speak, read, and write in English or Spanish
- Participating in the CANOE study (AAAR8497) and indicated they were willing to hear about future research opportunities
- Willing to write in a journal about their experiences
Exclusion Criteria
- Unavailable for follow-up
- Medical or psychiatric impairment that would prevent them from complying with the research protocol
Data sourced from ClinicalTrials.gov (NCT05144477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.