Short-time Behavioural Intervention in Post-Covid Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Physical Functioning
研究概览
简要总结
The present study is a 2-arm pragmatic randomised controlled trial (RCT) in which 310 patients who suffer from post-Covid syndrome are randomised to either a short-time outpatient-based rehabilitation program (the intervention) or care as usual in a 1:1 ratio. Assessments will take place immediately before randomisation (T0), after intervention or care as usual (T1), and 6 months after T1 (T2). Patients will be recruited from General Practitioners (GP's) as well as social media and self-referral to the involved institutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Fulfils pragmatic diagnostic criteria of idiopathic post-Covid syndrome: a) Confirmed acute Covid-19 by a positive PCR for SARS-CoV-2; b) Persistent symptoms at least 3 months following acute Covid-19 without symptom-free interval; c) Functional disability to an extent that interrupts all or a majority of normal activities (such as work/school attendance, physical exercise, social activities, etc.)
- •Lives in one of the following Norwegian counties: Oslo, Viken, Innlandet, Vestfold og Telemark, Agder
- •Informed consent to participation
排除标准
- •Other chronic illnesses or demanding life situations that might explain persistent symptoms and disability
- •Sustained organ damage (lung, heart, brain) following acute, serious Covid-19
- •Bedridden
- •Insufficient command of Norwegian language
结局指标
主要结局
Physical Functioning
时间窗: Immediately after intervention (time T1)
Physical Functioning subscale from the SF-36 inventory. The SF-36 comprises a total of 36 items on subjective mental, social and physical health, which are assigned to 8 dimensions. Scale ranging from 0 (poor quality of life) to 100 (best)
次要结局
- Fatigue(At 12 months follow-up (time T2))
- Depression/anxiety(At 12 months follow-up (time T2))
- Physical Functioning(At 12 months follow-up (time T2))
- Adverse effects(At 12 months follow-up (time T2))
- Recovery from PIFS(At 12 months follow-up (time T2))
研究者
Vegard Wyller
Professor
University Hospital, Akershus