Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
详细描述
Exclusion criteria:
- Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
- Patients with significant and unstable cardiovascular disease.
- Inability to understand and/or answer questionnaires.
- Refusal to use a smartphone or digital device.
- Unable to access an internet connection at home.
Analysis:
- The main analysis will be the univariate intention-to-treat analysis of the primary outcome.
- Secondary analyzes will include:
- Analysis with intention to treat secondary endpoints.
- Multivariate analysis of the efficiency criteria.
- Univariate and multivariate medico - economic cost - utility analyzes, with their respective sensitivity analyzes.
Protocol:
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
- None
盲法说明
This study will be an Open study.
For the primary outcome the analysis will be blind to the investigator
入排标准
- 年龄范围
- 40 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with COPD according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) creteria.
- •Presence of an incompletely reversible obstructive ventilatory disorder defined by a report VEMS / CVF lower than the lower limit of normal post-bronchodilator.
- •Patient on RR for four weeks in respiratory rehabilitation center.
- •Aged between 40 and 78 years.
排除标准
- •Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
- •Patients with significant and unstable cardiovascular disease.
- •Inability to understand and/or answer questionnaires.
- •Refusal to use a smartphone or digital device.
- •Unable to access an internet connection at home.
研究组 & 干预措施
Telerehabilitation
Experimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution. The solution will be provided during the fourth and final week of RR's stay during which patients will be trained to use all of the solution's features. Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1, 3, 6 and 12 months as well as assessments at 3, 6 and 12 months by filling. electronic auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home.
干预措施: telerehabilitation (Other)
Standard chronic care
following usual standard chronic care. Patients will receive during the last week of stay in the center, the usual advice to continue physical activity and nutritional advice at home. The evaluations at 3, 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home.
结局指标
主要结局
Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program
时间窗: 12 months
Quality of life assessed by the Saint Georges Respiratory Questionnaire. Three scores are calculated for the components: Symptoms; Activities; Impacts. A Total SCORE is also calculated. The minimum significant difference is 4 points.
次要结局
- Predictive model of physical activity behavior(At 12 months)
- Physical Activity behaviors.(12 months)
- Post-intentional variables(6 months)
- Pre-intentional variables(baseline)