Impact of Tele-visit Versus Home Visit by Home Care Provider on Compliance With Continuous Positive Airway Pressure (CPAP) Therapy of Patients With Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- To compare CPAP compliance between the two management modalities
研究概览
简要总结
To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP)
详细描述
Obstructive sleep apnea (OSA) syndrome is a chronic respiratory pathology affecting 4% of french adult population and reference treatment for moderate to severe forms of obstructive sleep apnea syndrome (OSA) is continuous positive airway pressure (CPAP).
However, CPAP treatment is binding, so nearly a quarter of patients abandoning treatment at 1 year and nearly half of them at 3 years. Support for these patients on CPAP must therefore be optimal and seek patient satisfaction; HCP (Home Care Provider) plays an important role in this follow-up.
Since 2018 in France, teleconsultation entered on common law but was little used. The pandemic has disrupted the habits of care and patients monitoring by developing remote monitoring. Home Care Providers (HCP) have also been forced to organize remote monitoring, particularly for the annual follow-up visit (technical tele-visit).
The impact of the annual follow-up visits of HCP by tele-visit has never been clinically evaluated. If its clinical relevance were demonstrated and patient satisfaction confirmed, this follow-up modality could become, like telecare, a new standard for the follow-up of patients on CPAP.
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
- •Age ≥ 18 years
- •CPAP ≥ 12 months and annual followed by "AGIR à dom" health care provider.
- •Compliance with CPAP ≥ 4h/night and AHI ≤ 5 events/hour on machine report for the 3 months prior to inclusion
排除标准
- •Follow-up by AGIR à dom. for an other service than package F9.1 : CPAP follow-up and remote monitoring
- •Unacceptable level of mask leakage
- •Patient unavailable or willing to move within the next 12 months to an area not covered by AGIR à dom.
- •Patient considered by the investigator to be unfit for a tele-visit
研究组 & 干预措施
home visit by HCP
Standard care : patients receive an annual CPAP home visit by HCP technician
tele-visit by HCP
Patients receive a annual CPAP remote visit by HCP technician, then home visit the following year
干预措施: tele-visit (Procedure)
结局指标
主要结局
To compare CPAP compliance between the two management modalities
时间窗: Over the 3 months (tele)visit follow-up
CPAP mean compliance between intervention and control groups, adjusted for the three months prior to inclusion : in hours/day, collected on the CPAP remote monitoring report
次要结局
- To compare treatment quality on mask leakage between the two management modalities(Over the 3 months (tele)visit follow-up)
- To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities(Over the 3 months (tele)visit follow-up)
- To compare impact on quality of life between the two management modalities(At 3 months after (tele-)visit follow-up)
- To compare follow-up impact in addition to the annual visit between the two management modalities(Over the 12 months (tele)visit follow-up)
- To compare overall patient satisfaction between the two management modalities(Immediately after the (tele-)visit follow-up)
- To compare impact on CPAP continuation between the two management modalities(Over the 12 months (tele)visit follow-up)
- To compare treatment effectiveness between the two management modalities(Over the 12 months (tele)visit follow-up)
- To evaluate failed visits number between the two care modalities(Over the 12 months (tele)visit follow-up)
- To evaluate technician satisfaction with tele-visits(Immediately after the (tele-)visit follow-up)
- To compare the impact on daytime sleepiness between the two management modalities(At 3 months after (tele-)visit follow-up)
- To compare CPAP compliance in medium term between the two management modalities(Over the 12 months (tele)visit follow-up)
- To evaluate patient satisfaction with tele-visits(Immediately after the (tele-)visit follow-up)
- Comparison of the environmental impact associated with the two patient follow-up methods (home visit versus tele-visit)(Over the 12 months (tele)visit follow-up)