Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- Number of re-entries in patients with heart failure
研究概览
简要总结
The goal of this clinical trial investigation with device is to determinate the effectiveness of remote monitoring of patients with heart failure with reduced ejection fraction heart (EFS40%) using Caaring® software.
The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with heart failure in the course of their disease will reduce the number of re-entries. For this, researchers will compare the assessments between the two groups.
This is a randomized study with two arms. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Prospective Control group: The data of these patients are collected prospectively for their routine medical visits for 12 weeks after their inclusion.
In addition, Control group patients must have clinical data from the 12 weeks after to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous monitoring devices.
Participants with heart failure will continue to receive conventional care and must have sufficient technological skills to use a smartphone.
详细描述
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.
The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.
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
- •Patients aged 18 years or older
- •Patients diagnosed with heart failure with reduced ejection fraction (EFS40%)
- •Patients discharged after an episode of acute heart failure and/or patients who are being followed up after being admitted for heart failure.
- •Patients who extensively use a smartphone.
- •lnformed Consent is obtained from the patient
排除标准
- •Patients with cognitive ar sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions ar the scales, as long as they do not have a legally authorized representative capable of participating in the study.
- •Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
- •Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.
- •Patients whose main diagnosis is a poorly controlled mental disorders ar other medical illness.
- •Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
- •lnstitutionalized patients
- •Patients who are pregnant ar breastfeeding.
- •Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months.
结局指标
主要结局
Number of re-entries in patients with heart failure
时间窗: Day 0, Week 12
Number of re-entries in patients with heart failure
次要结局
- Changas in the patient's MEDAS scale: Adherence to Mediterranean Diet(Day 0, Week 12)
- Patient satisfaction with the software Caaring(Week 12)
- Adherence treatment equal to 100%(Day 0 and Weekly up to 12 weeks)
- Changes in Health-related quality of life (WHOQOL)(Day 0, Week 12)
- Adherence treatment equal to or greater than 80%(Day 0 and Weekly up to 12 weeks)
- Changes in the patient's Clinical Data(Day O, every 3 days up to Week 12)
- Changes in the patient's in Liquid Consumption(Day 0, Week 12)