One Heart to Care for, Your Heart to Take Care of.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 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). Besides the normal consultations at 2 and 5 weeks, no active interactions take place between the study nurse and the patient.
The telemonitoring interference in the other study arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. During the first 12 weeks, the nurse of the call center will give incentive for medication up titration on the basis of the available data. Before up titration can be done, the patient needs to take blood pressure measurements 3 times in the morning and 3 times in the evening and at least 6 measurements a week.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age ≥ 50
- •Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt
- •The patient has to be able to live independently or in a service flat
- •The diagnosis of heart failure or severe myocardial infarction has to be done after September 1, 2013 according to:
- •Left ventricular ejection fraction (LVEF) <40%
- •eGFR>30ml/min/kg
- •Treatment minimally with ACE-I and BB
- •The general practitioner had to give his approval for the installation of telemonitoring On the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligibil 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
- •eGFR less than 30ml/min/kg
- •Presence of a cardiac resynchronization therapy (CRT) device
- •Palliative status following the RIZIV guidelines or according to the assessment of the cardiologist (<1 year)
- •Patients staying in a nursing or retirement home
- •Active treatment with either ACE-I/ARB or BB
结局指标
主要结局
Mean medication doses
时间窗: week 24
Define whether the mean medication doses of angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB) in the group with telemonitoring is higher than in the group with usual care (without telemonitoring) after 6 months
次要结局
- All-cause mortality(Up to one year)
- Medication titration(up to one year)
- All cardio-related hospitalisations (number and time)(Up to one year)
- All heart failure hospitalisations(Up to one year)
- Number of (telephone) contacts for the encouragement of medication compliance(Up to one year)
- Number of (telephone) contacts, registered by the heart failure nurse(Up to one year)
- Satisfaction survey(month 12)
- Number of medical practitioner-patient contacts(Up to one year)
- Evolution of heart failure and comorbidities(up to one year)
- Quality of life according to the HeartQoL questionnaire(day 1, month 12)
研究者
Pieter Vandervoort
prof. dr.
Hasselt University