COPD Online Rehabilitation (CORe) - a Randomized, Multicenter Telemedicine Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 14
- 主要终点
- Change in 6-Minute Walk Test Distance (6MWT)
研究概览
简要总结
International and national publications emphasize that COPD rehabilitation is a key cornerstone in the standard treatment of COPD, based on more than 15 years of research in COPD rehabilitation. COPD rehabilitation improves quality of life, anxiety and depression and physical function. COPD rehabilitation including special physical training, patient-directed education and smoking cessation is core rehabilitation elements, which today are recommended as mandatory content in standard COPD rehabilitation.
Standard COPD rehabilitation is an established offer in all regions and municipalities in Denmark. It is however a well-known challenge, that persons with the most severe COPD symptoms and co-morbidities are most likely not to receive COPD rehabilitation. Frequent exacerbations, socially isolation, transport distance to rehabilitation are main reasons why people with severe COPD disease deliberately chooses not to receive COPD rehabilitation. Why there at present are no rehabilitation alternatives for patients with the most severe COPD symptoms, supervised COPD Online rehabilitation in groups, delivered by health professionals in the COPD patients' own home via a computer screen could likely encourage more people to participate. The number of RCT's investigating the effect of supervised Online delivered COPD rehabilitation in groups versus established COPD rehabilitation are very limited.
The purpose of this randomized study is to investigate the short-term and long-term efficacy of 10 weeks of online COPD rehabilitation versus conventional supervised COPD rehabilitation in people with severe and very severe COPD. The outcome of the intervention is measured on walking distance, muscle endurance, activity level, quality of life and COPD symptoms respectively. Outcomes are measures before intervention start, end of intervention. This study also collects follow-up update after 3, 6 and 12 month. The follow-up data will be in separate publication.
Hypothesis
- COPD online rehabilitation provides significant larger improvements than the usual care on walking distance, muscle endurance, activity level, and quality of life and COPD symptoms in people with severe and very severe COPD.
- COPD online rehabilitation and conventional COPD rehabilitation, provides clinically relevant improvement on walking distance, muscle endurance, activity level, quality of life and COPD symptoms in people with severe and very severe COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
All assessors are blinded to group allocation and previous test results. Due to the nature of the study the patients cannot be blinded, but prior to the assessments they are reminded not to disclose their group allocation to the assessors. In case of failure keeping the outcome assessor blinded (that is, if a participant reveals his/her allocation) a second assessor will be available to step in and conduct the assessment on another day.
To avoid investigators (subconscious) bias the biostatistician who perform the data analyses and validate the results will be blinded to group allocation.
The research group will interpret the results, and the conclusion will be prepared in two versions before the allocation code is broken (one assuming that arm A is the intervention, and one assuming that arm B is the intervention).
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
- •Clinical diagnosis of COPD defined as a ratio of forced expiratory volume at one second (FEV1) to forced vital capacity < 0.70
- •FEV1 <50%, corresponding to severe or very severe COPD
- •Symptoms equivalent to the Medical Research Council (MRC) from 2 to 5
排除标准
- •Concurrent participation in or recent completion of pulmonary rehabilitation within the last six months.
- •Dementia/ Cognitive impairment or uncontrolled psychiatric illness,
- •An impaired hearing and / or vision which causes the instructions in the rehabilitation is not understood.
- •Unable to understand and / or speak Danish.
- •Unable to read Danish.
- •Severe co-morbidity that are contraindicated to rhe clinical exercise protocol.
结局指标
主要结局
Change in 6-Minute Walk Test Distance (6MWT)
时间窗: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
In-clinic test that measures exercise capacity
次要结局
- Change in Clinical COPD Questionaire (CCQ)(baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
- Change in 30 second sit-to-stand test (30-STST)(baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
- Change in COPD Assessment Test (CAT)(baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
- number of hospital admissions(number of hospital admissions - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up))
- Change in Activity level (ActivPAL)(Worn by the patients around the clock for 5 days in a private home at baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
- Change in Hospital Anxiety and Depression Scale (HADS)(baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
- Outpatient visits in hospital and at general practioner(number of outpatients visits in hospital and at general practioner - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up))
- Change in Euro Qol (EQ5D)(baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
- Total attendance in rehabilitation(after 10 weeks)
- Number of hospital days(number of hospital days - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up))
- Mortality(after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up))
研究者
Henrik Hansen
Ph.D. student, Physiotherapist, Master of Health Sciences, Project Manager,
University Hospital Bispebjerg and Frederiksberg