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NCT07087132

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

Completed Last updated 17 March 2026
What this trial tests

trial in Family Satisfaction in 666 participants. Completed in 15 February 2025.

Timeline
1 April 2024
Primary endpoint
15 February 2025
15 February 2025

Quick facts

Lead sponsorHospitalsenheden Vest
StatusCompleted
Study typeOBSERVATIONAL
Enrollment666
Start date1 April 2024
Primary completion15 February 2025
Estimated completion15 February 2025
Sites2 locations across Denmark

Conditions studied

Sponsor

Hospitalsenheden Vest

Who can join

18 and older, any sex, with Family Satisfaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Translation and Validation of the Canadian ICU Family Satisfaction Questionnaire (FS-ICU-24R) to Danish-A Protocol.
    Nielsen AH, Ågård AS, Collet MO, Brix LD. · · 2025 · cited 2× · PMID 40922387 · DOI 10.1111/aas.70123
  2. Translation and Cultural Adaption of the Revised ICU Family Satisfaction Questionnaire (FS-ICU-24R) Into Danish.
    Ågård AS, Jepsen AT, Frydendal CK, Donovan K, et al · · 2026 · PMID 41742440 · DOI 10.1111/aas.70210

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Trials by the same sponsor.

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