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

NCT05144477 | Completed Results

• 2 other identifiers: AAAT7681P30AG064198
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Family Members; Couples; Partners; Fear; Fear of Exercise; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study

  This is to assess feasibility of recruitment. Potential family member participants whom the study team approaches and agree/consent to take part in the study will be tallied. Specifically, we divided the number of family member participants who enrolled in the study by the number of potential participants referred to the study (enrolled/referred).

  Baseline (ICU admittance)

• Proportion of Enrolled Family Members Who Complete the Pilot Study

  This is to estimate/assess retention. Family members who remain in the study at the final assessment will be tallied. Specifically, we divided the number of family member participants who completed the study by the number of potential participants who did not complete the study (completed/did not complete).

  30 days post-discharge

Secondary Outcomes (5)

• Proportion of Family Members That Adhere to the Diary Intervention

  Up to hospital discharge (approximately 21 days)

• Proportion of Family Members That Complete the Majority of Survey Assessments

  Up to 30 days post-discharge

• Proportion of Family Members That Agree That the Intervention Was Acceptable

  30 days post-discharge

• Proportion of Family Members That Agree That the Intervention Was Feasible

  30 days post-discharge

• Proportion of Family Members That Agree That the Intervention Was Appropriate

  30 days post-discharge

Other Outcomes (3)

• Cardiac Anxiety Questionnaire Fear Subscale Score

  Hospital discharge (approximately 21 days), 30 days post-discharge

• Cardiac Anxiety Questionnaire Avoidance Subscale Score

  Hospital discharge (approximately 21 days), 30 days post-discharge

• Posttraumatic Stress Disorder Checklist Score

  30 days post-discharge

Study Arms (2)

FAID Fear Intervention

EXPERIMENTAL

Family members of CA patients assigned to intervention will receive the ICU diary.

Behavioral: FAID Fear Intervention

Control condition - Usual Care

NO INTERVENTION

Family members of CA patients assigned to usual care will not receive the ICU diary.

Interventions

FAID Fear Intervention BEHAVIORAL

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.

Also known as: Family-Authored ICU Diaries to Reduce Fear

FAID Fear Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unavailable for follow-up
• Medical or psychiatric impairment that would prevent them from complying with the research protocol

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

CUIMC

New York, New York, 10032, United States

Location

Related Publications (10)

• Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.

  PMID: 22080636 BACKGROUND

• Gump BB, Kulik JA. Stress, affiliation, and emotional contagion. J Pers Soc Psychol. 1997 Feb;72(2):305-19. doi: 10.1037//0022-3514.72.2.305.

  PMID: 9107002 BACKGROUND

• Rossignac-Milon M, Higgins ET. Epistemic companions: shared reality development in close relationships. Curr Opin Psychol. 2018 Oct;23:66-71. doi: 10.1016/j.copsyc.2018.01.001. Epub 2018 Jan 11.

  PMID: 29360060 BACKGROUND

• French CC. Dying to know the truth: visions of a dying brain, or false memories? Lancet. 2001 Dec 15;358(9298):2010-1. doi: 10.1016/S0140-6736(01)07133-1. No abstract available.

  PMID: 11755600 BACKGROUND

• Rosman L, Whited A, Lampert R, Mosesso VN, Lawless C, Sears SF. Cardiac anxiety after sudden cardiac arrest: Severity, predictors and clinical implications. Int J Cardiol. 2015 Feb 15;181:73-6. doi: 10.1016/j.ijcard.2014.11.115. Epub 2014 Nov 18.

  PMID: 25482282 BACKGROUND

• Edmondson D, Richardson S, Falzon L, Davidson KW, Mills MA, Neria Y. Posttraumatic stress disorder prevalence and risk of recurrence in acute coronary syndrome patients: a meta-analytic review. PLoS One. 2012;7(6):e38915. doi: 10.1371/journal.pone.0038915. Epub 2012 Jun 20.

  PMID: 22745687 BACKGROUND

• Monane R, Sanchez GJ, Kronish IM, Edmondson D, Diaz KM. Post-traumatic stress disorder symptoms and aversive cognitions regarding physical activity in patients evaluated for acute coronary syndrome. Eur J Prev Cardiol. 2018 Mar;25(4):402-403. doi: 10.1177/2047487317746255. Epub 2017 Dec 4. No abstract available.

  PMID: 29198138 BACKGROUND

• Rafaeli E, Gleason ME. Skilled support within intimate relationships. Journal of Family Theory & Review. 2009;1(1):20-37.

  BACKGROUND

• Nielsen AH, Angel S, Egerod I, Hansen TB. The effect of diaries written by relatives for intensive care patients on posttraumatic stress (DRIP study): protocol for a randomized controlled trial and mixed methods study. BMC Nurs. 2018 Aug 16;17:37. doi: 10.1186/s12912-018-0306-y. eCollection 2018.

  PMID: 30127664 BACKGROUND

• Nielsen AH, Angel S, Egerod I, Lund TH, Renberg M, Hansen TB. The effect of family-authored diaries on posttraumatic stress disorder in intensive care unit patients and their relatives: A randomised controlled trial (DRIP-study). Aust Crit Care. 2020 Mar;33(2):123-129. doi: 10.1016/j.aucc.2019.01.004. Epub 2019 Feb 20.

  PMID: 30795978 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Combat Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dr. Talea Cornelius
• Organization: Columbia University Irving Medical Center

tmc2184@cumc.columbia.edu

(212) 342-5503

Study Officials

• Talea Cornelius, PhD, MSW, MS

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: November 29, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 28, 2023
• Results First Posted: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)