What is the Prognosis of Functional Ability, Symptoms and Quality of Life in Patients That Are Treated in a University Hospital Because Symptoms of Post Covid-19 Condition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change from baseline of WHODAS2.0 questionnaire as measured at 12 months
研究概览
简要总结
Up to 20% of patients with Covid-19 develop symptoms that last more than 3 months, which is known as long Covid or Post-Covid-19 condition. The mechanism of the long term symptoms is not totally understood although inflammation, autoimmune reactions and thromboembolism are among suspected contributors. At Helsinki University hospital, a long Covid clinic was opened in June 2021. The aim of this cohort study is to monitor the patients that attend the clinic, follow up their functional abilities, quality of life and prognosis.
详细描述
The patients are asked to give their informed consent for the participation in the cohort study. They fill in a questionnaire before entering the clinic that assesses their symptoms, previous medical history, medications, lifestyle, symptoms, sleep, psychosocial measures including depression, anxiety, resilience and quality of life.
The patients are asked to give blood samples that rule out other diseases that may cause the symptoms. At the clinic, they attend a physician's consultation with physical exam. Later, in another apppointment, a physicotherapist assesses their physicial functioning including 6 minutes walking test and grip strength. They also attend a psychologist who conducts short, 30 min neuro-cognitive testing.
Patients receive psychoeducation of the Post Covid-19 condition and individual, tailored support and rehabilitation. They are given the opportunity to take part in group counselling once a week during 6 weeks.
The patients are followed up by nurse telephone calls at 3, 6 and 12 months as well as by questionnaires via a secured website.
The main outcome measure in this study is functional ability as measured by WHODAS2.0.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosed Covid-19 infection at least 3 mo before entry (either PCR positive or antigen test positive or hospitalisation because of Covid-19)
排除标准
- •patients for whom participation would be too exhausting, for example bed patients
- •patients who cannot fill in the questionnaires in Finnish
结局指标
主要结局
Change from baseline of WHODAS2.0 questionnaire as measured at 12 months
时间窗: 0, 3, 6, and 12 months
Functional ability measured by WHODAS2.0 which is a measure developed by WHO and has 36 items. The minimum value is 0, the maximum value is 100. Higher score means worse functional ability.
次要结局
- Sleep(0, 3, 6, and 12 months)
- EUROHIS-8 Quality of life(0, 3, 6, and 12 months)
- Depression(0, 3, 6, and 12 months)
- Anxiety(0, 3, 6, and 12 months)
- Health related quality of life(0, 3, 6, and 12 months)
- Symptom severity(0, 3, 6, and 12 months)
- Resilience(0, 3, 6, and 12 months)
- SSD-12, somatic symptom disorder(0, 3, 6, and 12 months)
研究者
Helena Liira
Chief Physician
Helsinki University Central Hospital