Sponsor study identifier
observational
666
1 country
2
Study Start
April 1, 2024
Actual (reported)Primary Completion
February 15, 2025
Actual (reported)Study Completion
February 15, 2025
Actual (reported)Translation and adaption to a Danish context of the family satisfaction questionnaire FS-ICU-24R. Furthermore, the study will test if the questionnaire adequately measures family satisfaction and is stable over time. At least 250 relatives of patients, who have been admitted to the intensive care unit at least 24 hours will be included. Relatives will be recruited, when the patients discharge is coming close, i.e. within days. All included relatives will receive the questionnaire on e-mail one month after they registered for the study. Participants will be prompted twice, if they not respond. After completing the questionnaire once, participants will be asked to complete it a second time after 14 days. The aim is to include at least 50 relatives in this group. To understand if the questionnaire is measuring family satisfaction, the study will compare the answers to FS-ICU-24R with a score of 1-10 of General satisfaction with the patients care, General satisfaction with information and General satisfaction with decision making. Stability over time will be assessed by comparing responses between first and second time, participants fill out the questionnaire. Participation will be voluntary and all participants will recieve written and oral information before registering for the study. The participants will register for the study by entering their e-mail into a secure on-line platform.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2024
Actual (reported)February 15, 2025
Actual (reported)February 15, 2025
Actual (reported)July 18, 2025
Actual (reported)July 25, 2025
Actual (reported)Family satisfaction
Summary score of items 1-24 in the FS-ICU-24R questionnaire
1 month post discharge from the intensive care unit.
Family satisfaction with care
1 month post discharge from the intensive care unit.
Family satisfaction with decision making
1 month post discharge from the ICU
Test-retest reliability
one month post ICU discharge
Relatives to patients admitted to Danish intensive care units.
Aarhus University Hospital
Aarhus, 8000, Denmark
Gødstrup Hospital
Herning, 7400, Denmark
Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. doi: 10.1097/01.CCM.0000251122.15053.50.
Jensen HI, Downey L, Koopmans M, Curtis JR, Engelberg RA, Gerritsen RT. Family ratings of ICU care. Is there concordance within families? J Crit Care. 2020 Feb;55:108-115. doi: 10.1016/j.jcrc.2019.10.011. Epub 2019 Oct 31.
666 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2025
First Posted
July 25, 2025
Study Start
April 1, 2024
Actual (reported)Contact the study team to confirm eligibility.
Harrison DA, Ferrando-Vivas P, Wright SE, McColl E, Heyland DK, Rowan KM; Family-Reported Experiences Evaluation Study Investigators. Psychometric assessment of the Family Satisfaction in the Intensive Care Unit questionnaire in the United Kingdom. J Crit Care. 2017 Apr;38:346-350. doi: 10.1016/j.jcrc.2016.10.023. Epub 2016 Nov 5.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
De Vet, H. C., Terwee, C. B., Mokkink, L. B., Knol, D. L. (2011). Measurement in medicine : a practical guide. Cambridge University Press.
Cha ES, Kim KH, Erlen JA. Translation of scales in cross-cultural research: issues and techniques. J Adv Nurs. 2007 May;58(4):386-95. doi: 10.1111/j.1365-2648.2007.04242.x. Epub 2007 Apr 17.
Nielsen AH, Agard AS, Collet MO, Brix LD. Translation and Validation of the Canadian ICU Family Satisfaction Questionnaire (FS-ICU-24R) to Danish-A Protocol. Acta Anaesthesiol Scand. 2025 Oct;69(9):e70123. doi: 10.1111/aas.70123.
Primary Completion
February 15, 2025
Actual (reported)Study Completion
February 15, 2025
Actual (reported)Last Updated
March 17, 2026
Record last verified: 2026-02
The investigators do not have permission to share data.
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Source: ClinicalTrials.gov.
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