NCT05144477|CompletedResults
Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear)
FAID Fear
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FAID Fear
Sponsor study identifier
Secondary identifiers
NIH
interventional
16
1 country
1
Study Start
November 29, 2021
Actual (reported)Primary Completion
November 30, 2022
Actual (reported)Study Completion
November 30, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 22, 2021
Actual (reported)November 29, 2021
Actual (reported)December 3, 2021
Actual (reported)November 30, 2022
Actual (reported)November 30, 2022
Actual (reported)April 28, 2023
Actual (reported)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
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
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
Family members of CA patients assigned to intervention will receive the ICU diary.
Family members of CA patients assigned to usual care will not receive the ICU diary.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CUIMC
New York, New York, 10032, United States
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.
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.
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.
Talea Cornelius, PhD, MSW, MS
Assistant Professor of Medicine
16 participants (actual enrollment reported by the registry).
First Submitted
November 22, 2021
First Posted
December 3, 2021
Study Start
November 29, 2021
Actual (reported)A Comparison of CPR Outcomes Between Traditional and Endomorphic Manikins With and Without Equipment
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Rafaeli E, Gleason ME. Skilled support within intimate relationships. Journal of Family Theory & Review. 2009;1(1):20-37.
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.
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.
Primary Completion
November 30, 2022
Actual (reported)Study Completion
November 30, 2022
Actual (reported)Last Updated
April 28, 2023
Results First Posted
April 28, 2023
Record last verified: 2023-04
Explicit permission from participants to post de-identified data online was not obtained; rather, participants consented that, "Upon removal of identifiers from the dataset, data may be shared with other researchers." In accordance with recommendations for sharing raw clinical data for publication stating that it is ideal to obtain this consent, data are available only by request from the study PI. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. Bmj. 2010;340.
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