COVID-19 Follow up Intensive Care Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Effect of an ICU admission on return to work
研究概览
简要总结
Since the SARS-CoV-2 infection is relatively new, the long term attributable burden related to COVID19 has not been investigated yet. To date, in patients with COVID-19 and their family members, there is little information on the functional status, cognitive ability, pattern of return to work, and health related quality of life after the ICU admission.
This study aims to describe the psychological wellbeing, physical - and social functioning of COVID-19 ICU survivors and their family members up to 12 months following ICU discharge.
详细描述
Study design The COVID-19 Follow up Intensive Care Study (COFICS) is a single center, prospective cohort study performed at a University Medical Center in The Netherlands.
Study population The study population consists of all admitted critically ill COVID-19 patients with a > 48 hours ICU admission at the ICU of a University Medical Center and a family member of the patient. Family members in this study can be partners, other family members, or friends who are identified by the patient as important.
Sample size All consecutive patients admitted to the ICU of the University Hospital for respiratory distress due to COVID-19 between March 19th 2020 and September 30th 2020 will be enrolled. With consent of the patient, family member(s) of participating patients will be enrolled.
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
- 否
入选标准
- •≥ 18 years old
- •Ability to speak and write Dutch
- •Ability to conduct a telephone call
- •Diagnosed with COVID-19 infection (only in patients)
- •48 hours ICU admission (only in patients)
排除标准
- •Refuse to participate
- •Serious language barrier
- •Cognitive impairment
- •Severe psychiatric disorder
- •Chronic ventilator dependency (only in patients)
结局指标
主要结局
Effect of an ICU admission on return to work
时间窗: 12 months post ICU discharge
Return to work knowing; possible job loss, change of work activities and worsening employment status
Anxiety and Depression
时间窗: 12 months post ICU discharge
Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.
General Health
时间窗: 12 months post ICU discharge
MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain. The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.
Long function
时间窗: 12 months post ICU discharge (only in patients)
Spirometry test
Frailty
时间窗: 12 months post ICU discharge (only in patients)
Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.
Family functioning
时间窗: 12 months post ICU discharge
McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.
次要结局
- Educational level(3 months post ICU discharge)
- Social status(3 months post ICU discharge)
- APACHE IV(24 hours (only in patients))
- Body mass index(3 months post ICU discharge (only in patients))
- ICU stay(hospital discharge, an average of 4 weeks (only in patients))
- Mechanical ventilation(hospital discharge, an average of 4 weeks (only in patients))
- Discharge locationn(hospital discharge, an average of 4 weeks (only in patients))
- Relationship with the patient(3 months post ICU discharge (only in family members))
- Weight(12 months post ICU discharge)
- Diabetes(12 months post ICU discharge)
- age(24 hours (patient) / 3 months post ICU discharge (family member))
- Gender(24 hours (patient) / 3 months post ICU discharge (family member))
- Comorbidity(3 months post ICU discharge (only in patients))
- Delerium(hospital discharge, an average of 4 weeks (only in patients))
- Hospital stay(hospital discharge, an average of 4 weeks (only in patients))
- Mortality(12 months post ICU discharge (only in patients))
- Health care consumption(12 months post ICU discharge)
- Thrombosis(12 months post ICU discharge)
- Readmission(3 months post ICU discharge (only in patients))
- Hypertensive(12 months post ICU discharge)
研究者
Willem Dieperink
PhD
University Medical Center Groningen