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临床试验/NCT07087132
NCT07087132已完成不适用

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

Hospitalsenheden Vest2 个研究点 分布在 1 个国家目标入组 666 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
666
试验地点
2
主要终点
Family satisfaction

研究概览

简要总结

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.

详细描述

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.

Face 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.

Psychometric testing of FS-ICU-24R in a prospective cohort of Danish ICU relatives:

Recruitment 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.

Recruitment 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Relatives of ICU patients

结局指标

主要结局

Family satisfaction

时间窗: 1 month post discharge from the intensive care unit.

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

次要结局

未报告次要终点

研究者

发起方
Hospitalsenheden Vest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Højager Nielsen

Head of Research

Hospitalsenheden Vest

研究点 (2)

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