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临床试验/NCT02712541
NCT02712541已完成不适用

Caregiver Burden and Wellbeing in Relatives of Intensive Care Unit Patients

Karolinska University Hospital4 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
4
主要终点
Caregiver burden Index score

研究概览

简要总结

The purpose of this study is to determine whether there is an association between adverse physical and/or psychological outcome in ICU survivors and the caregiver burden for their relatives.

We hypothesize that relatives to ICU survivors with an incomplete physical and/or psychological recovery three months after ICU stay report a higher caregiver burden.

详细描述

This is a sub-study to the multicenter "PROGRESS study". Details of the PROGRESS study have been described elsewhere. Briefly, an observational study including 600-1000 adult ICU patients from ten European hospitals will be followed up during three months to identify potential risk factors for physical and psychological problems.

The sub-study is conducted in four Swedish hospitals (Karolinska University Hospital Solna, Södersjukhuset, Stockholm, Örebro University Hospital and Akademiska University Hospital in Uppsala). Relatives to patients included in the PROGRESS study, who give informed consent to participate are consecutively included in the study.

Consenting participants (relatives) will be approached after inclusion of the patient and asked to estimate their own health related quality of life (HRQOL) 2 weeks prior to the time point for patient ICU admission through a HRQOL questionnaire. This self-reported HRQOL data will be used as proxy for baseline data. Three months after ICU discharge, relatives to ICU survivors will receive the following questionnaires by postal mail; Caregiver Burden Index, HRQOL questionnaire, a questionnaire screening for symptoms of anxiety and depression and a questionnaire screening for symptoms of posttraumatic stress.

The relatives will also be asked to state the number of working days lost due to caretaking of the ICU survivor.

ICU survivors' physical and psychological outcome, assessed with BI, SF-36, PTSS-14 and HADS three months after ICU discharge, obtained in the main PROGRESS study, will be compared with relatives' reported caregiver burden.

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

  • Relatives are considered eligible if they are a) partner to the patient b) adult children, siblings, parents or close friend that share household with the ICU survivor

排除标准

  • Non-Swedish-speaking
  • Overt or documented cognitive impairment

结局指标

主要结局

Caregiver burden Index score

时间窗: Three months after patients' discharge from the ICU

Score compared between nearest of kin to patients with good or poor physical or psychological outcome (obtained in the main PROGRESS-ICU Study), three months after ICU discharge

次要结局

  • Short Form-36(Three months after patients' ICU discharge)
  • Hospital Anxiety and Depression Scale(Three months post ICU discharge)
  • Posttraumatic stress symptoms Inventory - 14(Three months post ICU discharge)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Sackey

Senior Consultant, Associate Professor

Karolinska University Hospital

研究点 (4)

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