A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)
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
- Change in medication adherence
研究概览
简要总结
TELEMED-HF is a randomized, controlled clinical intervention trial designed to: (1) examine the efficacy of an electronic Medication Adherence Support System (MASS) in improving and monitoring patients' medication adherence; to (2) i determine the effect of medication adherence on hospitalization and health care consumption.
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
- None
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
- •Stable systolic heart failure
- •New York Heart Association functional class II-III, with a decreased pump function (left ventricular ejection fraction (LVEF) <45%)
- •Titrated to the most optimal doses of ACE-inhibitor or Angiotensin Receptor Blocker, and beta-blocker
- •Receiving stable doses of at least 3 heart failure medications (at multiple times during the day) for 1 month with no plans to add or adjust heart failure medications or titrate further in the immediate future.
排除标准
- •Age younger than 50 years
- •Diastolic heart failure (intact pump function)
- •Myocardial infarction, invasive treatment (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), or hospitalization within 1 month prior to inclusion
- •Life-threatening comorbid conditions (e.g., cancer)
- •Diminished mental capacities (suspected cognitive decline will be confirmed by a mini mental state examination (MMSE))
- •History of psychiatric disorders apart from affective disorders (depression and anxiety disorders)
结局指标
主要结局
Change in medication adherence
时间窗: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
Objective medication adherence will be assessed using the MASS monitor output collected in a web-based application and the refill rates provided by the patients' pharmacies.
Change in number of hospitalizations (costs)
时间窗: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
A cost-benefit analysis will be assessed by means of the TiC-P questionnaire and event rate (and related DBC (diagnosis treatment combination, the Dutch system to allocate costs to treatments of specific patient groups)). The TiC-P questionnaire will enable us to compare healthcare consumption in the intervention and control group.
次要结局
- Change in psychological variables(Baseline, 6 months, 12 months, and 18 months)
- Change in self-care behavior and Quality of Life(Baseline, 6 months, 12 months, and 18 months)
- Course of disease severity(Baseline, 6 months, 12 months, and 18 months)
研究者
Nina Kupper PhD
Nina Kupper, PhD
Tilburg University