Rethink Pulmonary Rehabilitation (REPORT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- COPD Assessment Test (CAT)
研究概览
简要总结
Pulmonary rehabilitation (PR) is a cornerstone of care for people with COPD. There is robust evidence that PR improves exercise capacity, enhances health-related quality of life (QoL) and reduces healthcare utilization. PR is strongly recommended in guidelines for COPD management. Despite the compelling evidence for its benefits, PR is delivered to less than 30% of people with COPD. Access is particularly challenging, an especially for those with the most progressed disease stages.
We recently completed a randomized clinical trial, showing that approximately 1.100 patients annually are offered conventional hospital-based PR during routine consultations in the Capital Region of Denmark, but at least 700 patients declines participation.
No major cohort studies have been published from people with severe and advanced COPD who opt out of traditional pulmonary rehabilitation. By establishing such cohort study, objective and qualitative knowledge from assessments and patient interviews is collected in patients we have very limited access to and knowledge of. Additionally, the collected data will give a deeper insight and understanding and possibly enable us to design new delivery models to be tested in proper study designs.
详细描述
Objective This cohort study aims to describe and understand differences and similarities in characteristics among people with severe and advanced COPD who opt-in or opt out of PR services.
The study includes data from: socio-demographic, anthropometric, physical (function, activity, muscle strength, balance) characteristics as well as self-reported symptoms of anxiety, depression, fatigue, pain, lung symptoms, quality of life, sleep-quality, mortality, hospitaladmissions, length of stay and qualitative patient interviews.
Data from our completed trial study (NCT02667171) will be used as the opt-in PR comparison cohort.
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
- •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
- •Declines to participate in a conventional out-patient hospital-based PR program
排除标准
- •Concurrent participation in or recent completion of pulmonary rehabilitation within the last twelve months.
- •Dementia/ Cognitive impairment or uncontrolled psychiatric illness,
- •An impaired hearing and / or vision which causes the instructions in the assessment is not understood.
- •language difficulties which causes inability to follow instruction or complete patient reported outcome measures (PROM.)
- •Any comorbidity that are contraindicated to the assesment protocol.
结局指标
主要结局
COPD Assessment Test (CAT)
时间窗: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in points. Lower score indicates improvement
次要结局
- 6-Minute Walk Test Distance (6MWD)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Brief Pain Inventory (BPI)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Euro-Qol (EQ5D)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Hand-Grip Strength (JAMAR)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Length of hospital admissions (respiratory and all-cause)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Mortality (respiratory and all-cause)(baseline and 52 weeks reassessment, (potentially 104 weeks reassesment))
- Timed Up and Go Test(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Activity level (ActivPAL)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) - Worn by the patients around the clock for 5 days)
- Multidimensional Fatigue Inventory (MFI-20)(baseline and 52 weeks reassessment, (potentially 104 weeks reassesment))
- Short Physical Performance Battery (SPPB)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- 30 seconds sit-to-stand test (30sec-STS)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Pittsburgh Sleep Quality Index (PSQI)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Out-patient visits(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Number of hospital admissions (respiratory and all-cause)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
- Hospital Anxiety and Depression Scale (HADS)(baseline and 52 weeks reassessment, (potentially 104 weeks reassessment))
研究者
Henrik Hansen
Principal Investigator
Copenhagen University Hospital, Hvidovre