Translation and Validation of the FS-ICU-24R Into Danish

NCT07087132 | Completed

• 1 other identifier: 1-16-02-51-24
• Study Type: observational
• Target: 666
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Family Satisfaction

Keywords

FS-ICU-24R; Intensive Care; Family satisfaction

Outcome Measures

Primary Outcomes (1)

• Family satisfaction

  Summary score of items 1-24 in the FS-ICU-24R questionnaire

  1 month post discharge from the intensive care unit.

Other Outcomes (5)

• 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

Study Arms (1)

Relatives of ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Relatives to patients admitted to Danish intensive care units.

You may qualify if:

• Relative or close friend to an adult patient admitted to the intensive care unit for at least 24 hours.

You may not qualify if:

• Persons with cognitive deficits that makes them unable to give informed consent. Persons who cannot read Danish.

Sponsors & Collaborators

• Hospitalsenheden Vest: lead
• Aarhus University Hospital: collaborator
• University of Aarhus: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Gødstrup Hospital

Herning, 7400, Denmark

Location

Related Publications (8)

• 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.

  PMID: 17133189 BACKGROUND

• 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.

  PMID: 31715527 BACKGROUND

• 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.

  PMID: 27914907 BACKGROUND

• 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.

  PMID: 31078660 BACKGROUND

• 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.

  PMID: 18352969 BACKGROUND

• De Vet, H. C., Terwee, C. B., Mokkink, L. B., Knol, D. L. (2011). Measurement in medicine : a practical guide. Cambridge University Press.

  BACKGROUND

• 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.

  PMID: 17442038 BACKGROUND

• 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.

  PMID: 40922387 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: April 1, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)