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Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear)

NCT05144477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-04-28

Study results available
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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.

Conditions

  • Cardiac Arrest
  • Post Traumatic Stress Syndrome

Interventions

BEHAVIORAL

FAID Fear Intervention

Participants will receive a hard-cover diary, written instructions on diary completion, and a pen. A trained research assistant will meet with the participant face to face or via telephone and explain how to use the diary. Instructions will include recommended frequency for writing (at least twice a week) and tips on how to express themselves. Potential topics will also be addressed, including what to write about in the beginning, during the ICU, and after ICU discharge. The hard copy of the diary will remain with the family member participant, and they will be asked to continue writing in the diary at least until patient discharge from the hospital. Research assistants will check in with participants via weekly telephone calls to provide prompts to remind them to use the diary and support, as needed, if the participant reports difficulty in writing diary entries. These calls will last approximately 1-5 minutes and will continue until patient discharge from the hospital.

Sponsors & Collaborators

Principal Investigators

  • Talea Cornelius, PhD, MSW, MS · Assistant Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144477 on ClinicalTrials.gov