Monitoraggio Telematico di Pazienti Ricoverati in Ospedalizzazione a Domicilio Per Scompenso Cardiaco Acuto - Studio Pilota
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mean daily number of physician visits
研究概览
简要总结
"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, MONTEROSA is a monocentric randomized controlled open-label clinical trial evaluating the use of a telemonitoring/telemedicine (TM) suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care of patients admitted to a Hospital at Home service for acute decompensated heart failure.
The main objective of the study will be to evaluate the impact of TM on number of daily physician's visits. Secondary objectives will be to evaluate the impact of TM on number of daily nurse visits, on overall in-hospital mortality and on patient's and caregiver's quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 admitted in Hospital at Home with signs and/or symptoms of new-onset or decompensated heart failure, according with the definition of 2016 European Society of Cardiology (ESC) guidelines on Heart Failure
- •Written informed consent signed by both the patient and the main caregiver
排除标准
- •Main caregiver with low IT skills (e.g. unable to use a smartphone);
- •Patient in whom body weight or accurate daily urine output cannot be measured
- •Patient with history of neoplastic/degenerative disease and with estimated life expectancy less than 3 months
- •Patient with decompensated liver cirrhosis (Child-Pugh score B o C)
结局指标
主要结局
Mean daily number of physician visits
时间窗: From allocation through to HaH discharge, in mean 15 days
Mean daily number of physician visits during Hospital at Home (HaH) stay, defined as total number of physician visits during HaH stay, divided by days of HaH stay, for every single patient
次要结局
- Mean daily number of nurse visits(From allocation through to HaH discharge, in mean 15 days)
- Mean daily number of urgent physician visits(From allocation through to HaH discharge, in mean 15 days)
- Mean daily number of urgent nurse visits(From allocation through to HaH discharge, in mean 15 days)
- Overall mortality(From allocation through to HaH discharge, in mean 15 days)
- Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12)(At HaH discharge, in mean 15 days after allocation)
- Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12)(At patient's HaH discharge, in mean 15 days after allocation)
研究者
Dott.ssa RENATA MARINELLO
Principal Investigator
A.O.U. Città della Salute e della Scienza