Rehabilitation and Return to Everyday Life for Patients With Long COVID
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 914
- 试验地点
- 1
- 主要终点
- The degree of mental fatigue measured with The Mental Fatigue Scale
研究概览
简要总结
This non-randomised controlled trial will investigate if patients with long COVID receiving a structured and group-based rehabilitation intervention (The Long COVID Rehabilitation Intervention) will report a difference in mean change in self-reported mental fatigue measured by Mental Fatigue Scale and will report a mean difference in weeks of sick-leave obtained through the Danish Register for Evaluation of Marginalisation compared to usual practise over a 12-month follow-up period. Alongside the effectiveness evaluation, a economic evaluation study and process evaluation study will be conducted,
Patients from Aarhus Municipality, Central Denmark Region, Denmark, receive The Long COVID Rehabilitation Intervention and will be allocated to the intervention group. Patients receiving rehabilitation in the other municipalities of Central Denmark Region, Denmark, will be allocated to the control group. Alongside this, a health economic study and a process evaluation study will be conducted.
详细描述
The study is a non-randomised controlled trial with 12-month follow-up. Alongside this, a health economic study and process evaluation study will be conducted in line with the British Medical Research Council's framework for development and evaluation of complex interventions. The study will be reported in three separate scientific papers for each evaluation study.
This study aims to evaluate the effectiveness of a structured and group-based rehabilitation intervention, called The Long COVID Rehabilitation Intervention, with the goal to optimise the rehabilitation of patients experiencing long-term symptoms after COVID-19 (long COVID).
The primary hypothesis: A structured and personalised rehabilitation intervention for patients with long COVID is more effective evaluated on sick leave, mental fatigue and disability compared to usual rehabilitation.
To evaluate the aim, the intervention group (patients receiving The Long COVID Rehabilitation Intervention in Aarhus Municipality, Central Denmark Region, Denmark) will be compared to a control group (patients receiving rehabilitation in the 18 other municipalities in Central Denmark Region, Denmark).
The data will be handled in accordance with the World Medical Association Coherence Declaration of Helsinki and with the General Data Protection Regulation. The study is approved by the Danish Regional Data Protection Agency (J.nr. 1-16-02-655-20).
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The degree of mental fatigue measured with The Mental Fatigue Scale
时间窗: At inclusion and 12-month follow-up
The Mental Fatigue Scale measures the degree of mental fatigue through 15 questions covering affective, cognitive and sensory symptoms along with duration of sleep and daytime variation in symptom severity with a total score of 0-40. Higher score indicates higher degree of mental fatigue.
Number of weeks of sick leave obtained through the Danish Register for Evaluation of Marginalisation
时间窗: From inclusion to 12-month follow-up
The Danish Register for Evaluation of Marginalisation is a national register containing information on the Danish population. Sick leave is automatically registered when a person receives sick leave allowances.
次要结局
- Health related quality of life estimated with the European Quality of Life - 5 Dimensions 5 Levels (EQ-5D-5L)(At inclusion and 12-month follow-up)
- Disability estimated using The Post-COVID-19 Functional Status Scale(At inclusion and 12-month follow-up)