Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Performance of the device for early detection of AECOPD
研究概览
简要总结
The purpose of this study is to evaluate the ability of the Bora Care remote monitoring solution to detect early acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).
详细描述
Worldwide, COPD has been increasing for 20 years with nearly 300 million patients, i.e. 4 to 10% of the adult population (7.5% in France). According to the WHO, it is now the fourth leading cause of death in the world.
Acute exacerbations of COPD (worsening of symptoms requiring an increase in treatment) represent frequent events in the course of the disease and the consequences are significant for the patient in terms of vital prognosis, deterioration of respiratory function, impact on quality life and for the health system in terms of cost. Missed diagnosis and delayed treatment are associated with impaired outcomes. The prevention and early treatment of acute exacerbations of COPD therefore have a major role in the management of COPD patients and could be facilitated by telemonitoring tools.
The purpose of the present study is to validate the interest of remote monitoring of various parameters (cardio-respiratory, environmental, symptom questionnaires) to predict and detect early the occurrence of acute exacerbations of COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patient with COPD defined according to the SPLF recommendations, whose level of lung function in a stable state is known (measurement less than 12 months old)
- •Patient with at least one of the following criteria :
- •Hospitalized for a COPD exacerbation at the time of enrolment in the study, and having had at least one other exacerbation in the last 12 months
- •Followed-up and part of the active file of the site, having had at least 2 exacerbations during the last 12 months, including one with hospitalization
- •COPD patient with at least 2 exacerbations in the last 12 months, including one with hospitalization
- •Patient having given written informed consent to participate in the study
- •Patient affiliated to the French social security system
- •Exclusion Criteria
- •Vulnerable patient (minor, protected adult, prisoner)
- •Patient unable to use the BoraBand tool and without access to a caregiver
- •Presence of a comorbidity considered unstable or very severe by the investigator
- •Patient already participating in another interventional research study
排除标准
- 未提供
结局指标
主要结局
Performance of the device for early detection of AECOPD
时间窗: 12 months
Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study
次要结局
- Relation between AECOPD and measured parameters(12 months)
- Compliance(12 months)
- Symptoms - EXACT E-RS questionnaire(12 months)
- Description of AECOPD(12 months)
- Quality of Life CAT(12 months)
- Quality of Life EQ5D5L(12 months)
- Satisfaction(12 months)
- Symptoms - EXASCORE questionnaire(12 months)