Renewing Health RCT for the Evaluation of Remote Monitoring of Patients With Congestive Heart Failure (CHF) in Central Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of hospitalisations for heart failure
研究概览
简要总结
The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.
详细描述
The purpose of this study is to the evaluate the use of a mobile and PSTN phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. Following this; it is also hypothesized that this will also lead to a change in overall risk for CHF complications. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years.
- •Discharge from hospital after acute heart failure in the previous 3 months and FE < 40% or FE > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization
排除标准
- •Comorbidities prevalent on CHF with life expectation < 12 months.
- •Inability to use the equipment and help at home not available.
- •Myocardial infarction or percutaneous coronary intervention in the last 3 months.
- •Coronary artery bypass, valve substitution or correction in the last 6 months or scheduled.
- •Being on waiting list for heart transplantation.
- •Being enrolled in other trial.
研究组 & 干预措施
Usual Care
Patients in the control group receive usual care delivered by their primary care physicians and cardiologists. Usual care consists of regular visits to the specialist or primary care clinics every time a medication change is required, or a medical examination is needed.
Home telemonitoring of patients with CHF
干预措施: Home telemonitoring of patients with CHF (Procedure)
结局指标
主要结局
Number of hospitalisations for heart failure
时间窗: 12 months minimum
Combined end point of all cause mortality
时间窗: 12 months minimum
次要结局
- Health related quality of life as measured by the SF-36 v2(12 months minimum- at the entry point of the intervention and the end)
- Cardiovascular and all-cause mortality(12 months minimum)
- Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ)(12 months minimum- at the entry point of the intervention and the end.)
- Disease Specific Quality of Life using the Minnesota Living with Heart Failure questionnaire (MLHF)(12 months minimum- at the entry point of the intervention and the end.)
- Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)(12 months minimum)
- Patients' Acceptance-Satisfaction measured by the WSD Questionnaire(at 2nd and at 12th month)
研究者
Filippos Triposkiadis
Proffesor, Director of the Cardiology Department, University Hospital of Larissa
Regional Health Authority of Sterea & Thessaly