Visio-consultation Compared to Face-to-face Consultation During the Follow-up of Apneic Patients Treated by Continuous Positive Airway Pressure (CPAP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Consultation cost
研究概览
简要总结
Prospective multicenter open-label randomized clinical trial comparing videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .
详细描述
The annual management of Obstructive Sleep Apnea (OSA) patients treated by continuous positive air pressure (CPAP) aims to maintain an optimal level of care while offering to the patients a combined management of their pathology. This management aims to reduce the risk of cardio-metabolic pathologies.
However, the high prevalence of OSA in the general population reduces the ability to explore undiagnosed patients. The contribution of videoconsultation is now available and allows the management of OSA patients treated by CPAP.
The objective of this study is to compare the videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .
The results of this study could provide very important new data on the impact of videoconsultation on the monitoring a chronic respiratory pathology such as sleep apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Apneic patient treated with CPAP for more than 12 months and having an annual scheduled follow-up visit.
- •Adult patient who can give an informed consent.
- •Patient with access to a media (Smartphone, tablet or computer) and an Internet connection at home.
排除标准
- •Patient unable to use or understand the digital system.
- •Patient under guardianship or deprived of liberty
- •Pregnant woman
- •Patient in a period of exclusion from another clinical trial
结局指标
主要结局
Consultation cost
时间窗: 3 months after consultation
Non inferiority of visioconsultation compared to face-to-face consultation in terms of consultation cost evaluated by the difference in cost between the 2 types of consultation
Therapeutic adherence to CPAP
时间窗: 3 months after consultation
Non inferiority of visioconsultation compared to face-to-face consultation in terms of therapeutic adherence to CPAP evaluated by the difference in compliance 3 months before and 3 months after the consultation
Patient satisfaction: questionnaire
时间窗: 3 months after consultation
Non inferiority of visioconsultation compared to face-to-face consultation in terms of patient satisfaction evaluated by the VSQ-VF questionnaire
次要结局
- Sleepiness related to CPAP(3 and 12 after consultation)
- Tiredness related to CPAP(3 and 12 months after consultation)
- Evaluate the quality of CPAP treatment (Residual AHI)(3 and 12 months after consultation)
- Evaluate the quality of CPAP treatment (adverse events)(3 and 12 months after consultation)
- Evaluate the quality of CPAP treatment (mask leaks level)(3 and 12 months after consultation)
- Evaluate the quality of CPAP treatment (visits by the health care provider): number of visits by the health care provider and the reasons for these visits(3 and 12 months after consultation)
- Assess the risk factors associated with OSA in patients treated with CPAP (weight)(12 months after consultation)
- Assess the risk factors associated with OSA in patients treated with CPAP (blood pressure)(12 months after consultation)
- Assess the risk factors associated with OSA in patients treated with CPAP (level of physical activity)(12 months after consultation)