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

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.

NCT Number	NCT07087132
Lead Sponsor	Hospitalsenheden Vest Collaborators: Aarhus University Hospital, University of Aarhus, Rigshospitalet, Denmark
Conditions	Family Satisfaction
Enrollment	666 participants
Start Date	2024-04-01
Primary Completion	2025-02-15 (estimated)
Study Completion	2025-02-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-17