Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT07087132
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Translation and Validation of the FS-ICU-24R Into Danish
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-27', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Family satisfaction with care', 'timeFrame': '1 month post discharge from the intensive care unit.', 'description': 'Summary score of items 1-14 of the FS-ICU-24R questionnaire'}, {'measure': 'Family satisfaction with decision making', 'timeFrame': '1 month post discharge from the ICU', 'description': 'Summary score of the items 15-24 of the FS-ICU-24R questionnaire'}, {'measure': 'Test-retest reliability', 'timeFrame': 'one month post ICU discharge', 'description': "Spearman's correlation"}, {'measure': 'Construct validity', 'timeFrame': 'one month post ICU discharge', 'description': "Spearman's correlation"}, {'measure': 'Criterion validity', 'timeFrame': 'one month post icu', 'description': 'The investigators will compare the two subscales with a score of 1-10 of general satisfaction with care, general satisfaction with information and general satisfaction with decision making.'}], 'primaryOutcomes': [{'measure': 'Family satisfaction', 'timeFrame': '1 month post discharge from the intensive care unit.', 'description': 'Summary score of items 1-24 in the FS-ICU-24R questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FS-ICU-24R', 'Intensive Care', 'Family satisfaction'], 'conditions': ['Family Satisfaction']}, 'referencesModule': {'references': [{'pmid': '17133189', 'type': 'BACKGROUND', 'citation': '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': '31715527', 'type': 'BACKGROUND', 'citation': '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': '27914907', 'type': 'BACKGROUND', 'citation': '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': '31078660', 'type': 'BACKGROUND', 'citation': "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': '18352969', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'De Vet, H. C., Terwee, C. B., Mokkink, L. B., Knol, D. L. (2011). Measurement in medicine : a practical guide. Cambridge University Press.'}, {'pmid': '17442038', 'type': 'BACKGROUND', 'citation': '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': '40922387', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAt 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.\n\nAfter 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.\n\nTo 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.\n\nParticipation 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.', 'detailedDescription': "Method Translation and adaption: The FS-ICU-24R (the family satisfaction with the ICU 24 item questionnarie) will be translated into the Danish language in agreement with one of the original authors, Dr. Daren Heyland. The initial forward translations will be produced by four bilingual nurses all Danish native speakers. Afterwards, the translations will be discussed with two researchers and a pooled version will be produced. Translation of key terms will be thoroughly discussed before deciding on the most appropriate wording. The investigators will opt for a conceptually and culturally sound translation rather than a literal translation, which will be acceptable to the users of the instrument: relatives of ICU patients. Back translation will be undertaken by a bi-lingual nurse, who will be blinded to the original version at all stages of the translation process. The research group will compare the backward version with the source instrument and a second version of the questionnaire will be produced. The process will be repeated to resolve minor discrepancies as needed.\n\nFace and content validity: The Danish version will be presented to 4-6 relatives, who will be interviewed about their perceptions and understanding of the questionnaire. Following the administration of the instrument, all relatives will be interviewed. For each item, relatives will be asked to describe in their own words what they think the item is about and how they chose their answer. Furthermore, if an item is difficult to understand or ambiguous, relatives will be asked to provide alternative wording. Notes and comments made during the interviews on the questionnaire items will be discussed by the researchers before a final version of the questionnaire will be produced. One of the original authors, Dr. Daren Heyland, will approve of the final back translation.\n\nPsychometric testing of FS-ICU-24R in a prospective cohort of Danish ICU relatives:\n\nRecruitment procedure: Relatives will be informed in person about the study while in the ICU. If relatives agree to participate, they must register for the study using a smartphone and a QR code. If a participant prefers to complete the questionnaire on paper, a package containing the questionnaire, information about the study and a return envelope will be supplied with instructions on when to fill in the questionnaire and how to return it. The site will only need to register how many packages have been distributed.\n\nRecruitment of participants to the subgroup test-re-test analysis: When completing the questionnaire in REDCap relatives will be asked to participate a second time for a test-re-test analysis.\n\nSample size: The reseach group aim to include at least 250 relatives. Several family members from the same family may be included. For criterion and construct validation it is recommended to include more than 100 patients. For confirmatory factor analysis, it is recommended to include 4-10 respondents per item. As the SF-ICU-24R has 26 items and 3 items for bereaved relatives only, at least 250 relatives must be included. Although relatives of the same patient may have some shared experiences, a validation study of the EuroQ2 instrument, which contains many of the same questions, showed that identical ratings only occurred in 28-59% of families. This study supports that relatives' experiences from the same patient trajectory can be surprisingly different. A subgroup of at least 50 relatives will be invited to complete the questionnaire a second time to explore test-retest validity.\n\nData: In the beginning of the questionnaire, participants will be asked to rate their overall emotional wellbeing, overall satisfaction with care, overall satisfaction with information and overall satisfaction with decision making on Likert scales 1-10 (1= worst imaginable, 10=best imaginable). P participants will then complete the Danish version of the FS-ICU-24R. After each section (satisfaction with care, satisfaction with information, satisfaction with decision making, and bereavement), the participants will be able to make comment in free text. Finally, the participants will be asked to provide background information on sex, age, education, and relationship with the patient.\n\nData collection: The questionnaire will be distributed by email through the secure web application REDCap hosted by Aarhus University and all data will be stored in REDCap at Aarhus University. For participants preferring to respond in paper, the study group will manually enter mailed responses into REDCap. Paper questionnaires will be coded to identify the issuing ICU."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Relatives to patients admitted to Danish intensive care units.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relative or close friend to an adult patient admitted to the intensive care unit for at least 24 hours.\n\nExclusion Criteria:\n\n* Persons with cognitive deficits that makes them unable to give informed consent. Persons who cannot read Danish.'}, 'identificationModule': {'nctId': 'NCT07087132', 'briefTitle': 'Translation and Validation of the FS-ICU-24R Into Danish', 'organization': {'class': 'OTHER', 'fullName': 'Hospitalsenheden Vest'}, 'officialTitle': 'Translation and Validation of the FS-ICU-24R Into Danish', 'orgStudyIdInfo': {'id': '1-16-02-51-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Relatives of ICU patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne Ågård, Ph.D.', 'role': 'CONTACT', 'email': 'anne.aagaard@skejby.rm.dk', 'phone': '4521625484'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '7400', 'city': 'Herning', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne H Nielsen, Ph.D, MCN, CCRN', 'role': 'CONTACT', 'email': 'annsve@rm.dk', 'phone': '4520158924'}], 'facility': 'Gødstrup Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'centralContacts': [{'name': 'Anne H Nielsen, Ph.D. MCN, CCRN', 'role': 'CONTACT', 'email': 'annsve@rm.dk', 'phone': '4520158924'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators do not have permission to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitalsenheden Vest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research', 'investigatorFullName': 'Anne Højager Nielsen', 'investigatorAffiliation': 'Hospitalsenheden Vest'}}}}