Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 621
- 试验地点
- 2
- 主要终点
- incremental cost effectiveness ratio (ICER)
研究概览
简要总结
The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost compared to that of the control group.
详细描述
Between January 2010 and June 2013, 621 patients with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled and randomly assigned to two study arms comprising usual care and a home telemonitoring group. The 302 patients enrolled in the intervention group are supported by an interactive bi-directional home telemonitoring system (Motiva®) that collects and transfers patient's vital sign data to a dedicated telemedicine data centre. All patients were to remain in the study for one year with an examination at the beginning and both, after 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Confirmed diagnosis of Chronic Heart Failure (CHF) based on European Society of Cardiology (ESC) guidelines
- •Symptoms corresponding to New York Heart Association (NYHA) functional class II-IV
- •Left Ventricular Ejection Fraction (LVEF) ≤ 40%
- •American Heart Association (AHA) classification stage C or D
- •Age > 18 years
- •Discharged after hospitalisation for worsening Chronic Heart Failure (CHF) within the last twelve months
- •Able to understand the German language
- •Sufficient eyesight to understand and follow the instructions communicated by the Motiva® platform
- •Willing and able to use the required hard- and software and maintain a patient diary
- •Residing within geographical reach of one of the ten study sites in order to receive additional treatment if required as well as follow-up consultation
- •Willingness to provide informed consent regarding benefits and risks related to the trial, and to sign a participation agreement for the installation of the telemedicine platform Motiva®
排除标准
- •Myocardial infarction within the past four weeks
- •Heart surgery or any coronary intervention within the past eight weeks
- •Cardiogenic shock within the past four weeks
- •Intended cardiac surgery within the next six months or priority status on a waiting list for organ transplantation
- •Severe chronic and pulmonary illness with an immediate impact on the main outcome measures
- •Renal failure requiring dialysis
- •Dementia or other severe cognitive impairment
- •Psychiatric disorders rendering patients unable to participate in the trial
- •Discharged to or living in a geriatric clinic or a nursing home
- •Participation in another clinical trial
结局指标
主要结局
incremental cost effectiveness ratio (ICER)
时间窗: 1 year
consisting of the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost
次要结局
- Clinical Outcomes - total mortality(1 year)
- Clinical Outcome - number of inpatient treatment(1 year)
- Clinical Outcome - length of stay in hospital or nursing home(1 year)
- Clinical Outcome - functional state of health(1 year)
- Clinical Outcome - health related quality of life(1 year)
研究者
Eckhard Nagel
Prof. Dr. Dr. Dr. h.c.
University of Bayreuth