Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Change of Quality of life assessed by the SF36 questionnaire
研究概览
简要总结
Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients.
This will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory.
The investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months.
The secondary objectives:
- To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:
- Treatment compliance (CPAP or NIV/oxygen therapy)
- Physical activity
- Weight
- Mean arterial pressure
- Oxygen saturation, heart rate and respiratory rate for COPD patients
- Severity of COPD for the patients concerned
- Daytime sleepiness
- Fatigue
- Patient acceptability of the use of connected objects
- To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.
- To analyze the daily data of the different connected objects and treatments with regard to the patients' profiles (according to age, gender, comorbidities, OSA or COPD group).
详细描述
Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. There is also an inequality of access to referral care linked to demographics and territorial organization. We are currently at a turning point in the understanding of these pathologies and their coordinated management by combining therapeutic modalities. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects measuring weight, oxygen saturation rate, heart rate, respiratory rate, skin temperature blood pressure or physical activity will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients.
This will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory.
The investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months.
The secondary objectives:
- To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a chronic respiratory pathology such as:
- •Newly diagnosed OSA with indication for CPAP treatment
- •And/or COPD with or without indication for NIV/oxygen therapy
- •Have a smartphone (with Android or iOS) allowing the installation of applications for connected objects
- •Be able to use a mobile application on a personal smartphone
- •Person agreeing to the telemonitoring of CPAP or NIV/oxygen therapy compliance data by the healthcare provider
- •Patient who has provided consent to participate in the study
- •Person affiliated to the social security
排除标准
- •Pregnant or breastfeeding woman
- •Patient unable to give consent to participate in the study
- •Patient under guardianship or curatorship
- •Patient not affiliated to the social security system
- •Patient deprived of liberty or hospitalized
- •Patient protected by law
- •Patient under administrative or judicial control
- •Patient currently participating in another clinical research study that may have an impact on the study, this impact is left to the discretion of the investigator
结局指标
主要结局
Change of Quality of life assessed by the SF36 questionnaire
时间窗: at inclusion and at 6 months
Change of quality of life, assessed by the SF36 questionnaire, from Baseline (at inclusion) and after 6 months of an integrated management at home
次要结局
- Daily oxygen saturation measured by the connected BORA Band for COPD patients only(During 6 months)
- Daily heart rate measured by the connected BORA Band for COPD patients only(During 6 months)
- Change of Weight measured by a connected scale(Before CPAP or NIV treatment, at Month 3 and Month 6)
- Change of Arterial pressure measured by a connected tensiometer(Before CPAP or NIV treatment, at Month 3 and Month 6)
- Change of Sleepiness evaluated by the Epworth questionnaire(At baseline, Month 3 and Month 6)
- Change of Fatigue evaluated by the Pichot questionnaire(At inclusion, Month 3 and Month 6)
- Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire(At Month 6)
- Change of Physical activity (average daily steps) for COPD patient only(One week before initiation of NIV treatment and at Month 3 and Month 6)
- Change of Physical activity (average daily steps) for OSA patient only(One week before initiation of CPAP treatment and at Month 3 and Month 6)
- Change of Physical activity assessed by the IPAQ questionnaire(At the inclusion, Month 3 and Month 6)
- Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients only(At Month 6)
- Daily respiratory rate measured by the connected BORA Band for COPD patients only(During 6 months)
- Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only(At the inclusion, Month 3 and Month 6)
- Satisfaction and usage of the connected scale assessed by a specific questionnaire(At Month 6)
- Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients only(At Month 6)