CARDIOCOACH: Development of an Intelligent Two-way Communication System to Coach Elderly Patients With Heart Failure in Their Home Situation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Mean medication doses
研究概览
简要总结
This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference.
When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care).
The telemonitoring interference in the other study arm consists of a smartphone application to register medication intake and to transmit the data of an automatic blood pressure device and a balance to a central platform. The goal is to improve medication uptitration (angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB)) in heart failure patients and to improve medication compliance.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt and has to live in the region Genk - Hasselt
- •The patient has to be cognitive strong enough and speak enough Dutch to communicate about their health situation and to understand the smartphone application
- •The diagnosis of systolic heart failure or severe myocardial infarction has to be done during consultation or hospitalization
- •Left ventricular ejection fraction (LVEF) <45%
- •Treatment minimally with ACE-I and BB On the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligible to join the study. The patient also needs to speak sufficient Dutch to be communicative about his/her medical condition.
排除标准
- •Reversible form of heart failure
- •Heart failure due to severe aortic stenosis
- •At the time of inclusion a eGFR less than 30ml/min/kg
- •Presence of a cardiac resynchronization therapy (CRT) device
- •Active treatment with either ACE-I/ARB or BB
- •Patient that are subscribed in a cardiac revalidation program when leaving the hospital
- •Patients with severe form of COPD (GOLD III)
研究组 & 干预措施
Telemonitoring group
Recieve a smartphone with an application to coach them, a blood pressure monitor and scale.
干预措施: Telemonitoring (Device)
Control group
Control group (usual care, without telemonitoring)
结局指标
主要结局
Mean medication doses
时间窗: 3 months
Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 3 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake.
次要结局
- Medication titration(after month 6)
- All-cause mortality(up to month 6)
- All cardio related hospitalizations (number and time)(up to month 6)
- All heart failure hospitalizations(up to month 6)
- Number of medical practitioner-patient contacts(up to month 6)
- Number of (telephone) contacts, registered by the heart failure nurse(up to month 6)
- Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)(up to month 6)
- Evolution of heart failure and comorbidities(up to month 6)
- Quality of life according to the HeartQoL questionnaire(day 1, month 6)
- Satisfaction survey(month 6)
研究者
Pieter Vandervoort
prof. dr.
Hasselt University