Tele-monitoring of Patients With Home Mechanical Ventilation. "MyVENT" Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Adherence to HMV treatment.
研究概览
简要总结
The purpose of this study is to improve HMV treatment adherence using an integrated telemedicine platform (MyVENT system)
详细描述
The investigators propose a study to evaluate the effect of using tele-monitoring in the follow-up of patients with HMV in order to improve their compliance and evaluate its cost-effectiveness. Telemedicine will be provided by an integrated platform composed by a website and a smartphone application for achieve a real feedback between patients and clinicians.
Design: Prospective randomized clinical study that will include 184 patients with HMV. The study will be divided in two phases, the first one consisting on the website and App system development and the second one consisting on a clinical trial where the two follow-up systems (standard care vs MyVENT group) will be compared.
Randomization: Patients will be randomised into two groups, HMV treatment management with standard care vs. telemedicine follow up.
Intervention:
Group 1:MyVENT group: patients will be followed up by tele-monitoring support. MyVENT System will be updated with data extracted from the ventilation equipment. This information and the results of the complementary tests will be sent to the clinician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Men and women over to 18 years old.
- •Signed informed consent.
- •Good knowledge about the use of smartphones.
- •Patients with Chronic Obstructive Pulmonary Disease (COPD), obesity-hypoventilation syndrome and chest wall disorders who had started HMV at least three months before their inclusion.
排除标准
- •Chronic pathology limiting life expectancy less than 1 year.
- •Psychiatric limiting problems.
- •Pregnancy
结局指标
主要结局
Adherence to HMV treatment.
时间窗: 9 months
The number of treatment hours will be obtained by the system counter
次要结局
- Treatment efficiency(9 months)
- Early detection of problems(9 months)
- Define the patient satisfaction(9 months)
- Cost effectiveness(9 months)
研究者
Ferran Barbe
MD
Sociedad Española de Neumología y Cirugía Torácica