Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 188
- 试验地点
- 7
- 主要终点
- Change from baseline the 6 minutes Stepper test at 2 months
研究概览
简要总结
The aim of this clinical trial is to establish the non-inferiority of home-based respiratory rehabilitation compared to respiratory rehabilitation in center in terms of exercise tolerance as evaluated by the 6 minutes Stepper test..
This trial will also 1°) evaluate the Medico-economic aspects of the home-based Respiratory rehabilitation versus respiratory Rehabilitation in center; 2°) analyse the patient preferences between home-based respiratory rehabilitation and respiratory rehabilitation in center and 3°) Compare home-based respiratory rehabilitation vs respiratory rehabilitation in center in terms of dyspnea, quality of life, anxiety and depression.
详细描述
The purpose of this study is to perform a comparative analysis of the clinical and medico-economic effectiveness of center-based RR versus home-based RR in the departments of Nord and Pas de Calais in France. All COPD patients eligible for RR and willing to participate in the study will be followed.
Patient preferences will be evaluated at inclusion. After presentation of both RR modalities, patients expressing a strong preference for one or other of the terms will be taken care of according to their wishes. Indifferent patients between the two RR modalities will be randomized.
This design is justified in the light of three cases:
- It is impossible to evaluate blind intervention,
- The effectiveness of RR depends on patient preferences,
- Patients' adherence to the protocol is facilitated.
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
- None
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
- •According to HAS recommendations, SPLF, ERS / ATS (3) (18) (19) can be included any patient, over 18 years old, with stage II - III - IV COPD presenting disabling dyspnoea in activities of daily living, and / or in the course of acute exacerbation of COPD (EABPCO), with no other respiratory pathology diagnosed.
排除标准
- •According to the recommendations, HAS, SPLF, ERS / ATS will not be included any patient having :
- •co-morbidities including unstabilized cardiovascular disease,
- •significant cognitive disorders: patients with a history of pathologies neurodegenerative with loss of mental faculties (example: Alzheimer)
- •psychiatric disorders: patients with impaired judgment and perception
- •neurological or orthopedic disorders that do not allow the realization of physical activities
- •Also, will not be included, the patient (s):
- •waiting for lung transplantation,
- •pregnant or nursing,
- •in an emergency situation
- •unable to receive enlightened information,
- •unable to participate in the entire study,
- •not covered by the social security scheme,
- •refusing to sign the consent,
结局指标
主要结局
Change from baseline the 6 minutes Stepper test at 2 months
时间窗: At 2 months
The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes
次要结局
- Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center(Baseline)
- Change from baseline the 6 minutes Stepper test at 6 and 12 months(at 6 months, at12 months)
- Cost of interventions: respiratory rehabilitation in center or at home(At 12 months)
- Change from Baseline COPD Assessment Test (CAT) at 2,6,12 months(baseline, after RR (2 months); 6 months and12 months)
- Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months(baseline, after RR (2 months); 6 months and12 months)
- Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months(Baseline, after RR (2 months); 6 months and12 months)
- EPICES score(baseline)