Multi-center, National, Randomized, Exploratory Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation (e-VENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 11
- 主要终点
- Nocturnal alveolar hypoventilation data
研究概览
简要总结
The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years. Its objectives were to provide a temporary public reimbursement for medical telemonitoring in order to determine the benefits for the patient and the impact on medical organization and healthcare costs. In particular, this program applies to patients suffering from hypercapnic chronic respiratory failure and requiring home non invasive ventilation (NIV). For these patients, the ETAPES program combines NIV telemonitoring and therapeutic education.
e-VENT study aims at evaluating the ETAPES program, implemented using the Chronic Care Connect™ telemonitoring solution, versus Standard of Care, on the effectiveness of home NIV, measured by average PtCO2, reflecting the level of nocturnal alveolar hypoventilation.
详细描述
A prospective randomized study with two arms.
The primary endpoint is the level of nocturnal alveolar hypoventilation, defined as the average PtCO2 in nocturnal capnography performed at 6th month.
Patients with hypercapnic chronic respiratory failure requiring home NIV (n=100).
Multi-center study conducted in France involving approximately 20 sites
Product under study: Chronic Care Connect Pneumology telemonitoring solution, combining:
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
- •Patient with chronic respiratory failure for whom treatment with home NIV was prescribed at inclusion or two months earlier, and whose service provider is ADEP Assistance, ADAIR Assistance, ARAIR Assistance or VitalAire,
- •Patient who meets all eligibility criteria to participate in the ETAPES program, namely:
- •Patient aged 18 and over;
- •Patient receiving NIV as part of an indication recognized by the Société de Pneumologie de Langue Française and the Haute Autorité de Santé;
- •Patient never before included in the ETAPES program for the remote medical monitoring of their chronic respiratory failure;
- •Patient having agreed to participate in the ETAPES program with the Chronic Care Connect Pneumology solution operated by the service providers ADEP Assistance, ADAIR Assistance, ARAIR Assistance or VitalAire, in the event that they are randomized to the Remote Medical Monitoring group;
- •Patient agreeing to the collection of data from their ventilator via remote transmission;
- •Patient fitted with a ventilator compatible with the Chronic Care Connect Pneumology solution;
- •Patient with health insurance cover;
- •Patient who has signed the consent form for the study.
排除标准
- •Patient who has any of the non-eligibility criteria for the ETAPES program:
- •Physical or mental inability to use all components of the remote medical monitoring project, as determined by the doctor wishing to include the patient in the remote medical monitoring project;
- •Patient with cancer with a life expectancy of less than 12 months estimated by the pulmonologist;
- •Patient with more than three COPD respiratory decompensations resulting in hospitalization within the previous 12 months;
- •Patient with diagnosed neuromuscular disease;
- •Estimated poor compliance or standard adherence to treatment according to the physician including the patient;
- •Patient's refusal of treatment support;
- •No permanent place of residence;
- •Patient participating in another intervention research program.
研究组 & 干预措施
"Telemonitoring" group
Medical Telemonitoring in Non-Invasive Ventilation
干预措施: ETAPES Program (Device)
"Standard of Care" group
Standard medical follow-up: standard home Non-Invasive Ventilation service, with transmission of their ventilator data without analysis leading to alerts
结局指标
主要结局
Nocturnal alveolar hypoventilation data
时间窗: 6th month
Average PtCO2, measured by transcutaneous capnography
次要结局
- Measurement of diurnal PaO2 and PaCO2(6th month)
- DIRECT questionnaire(1st month; 6th month)
- Patient satisfaction questionnaire about Telemonitoring services(6th month)
- Number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure(6th month; 12th month)
- Quality of NIV treatment(Through study completion, an average estimated at around 7 months)
- S3-NIV questionnaire(Through study completion, an average estimated at around 7 months)