NCT03171038已完成不适用
Long-term Impact of a 6-months Telemedical Care Program on Mortality, Readmissions and Healthcare Costs in Patients With Chronic Heart Failure The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study
Hasselt University0 个研究点目标入组 160 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- All-cause mortality
研究概览
简要总结
TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients.
详细描述
The telemonitoring (TM) group patients received a 6-months TM program, followed by standard heart failure care until the long-term follow-up evaluation.
The usual care (UC) patients received ususal care during the first six months, followed by standard heart failure care until the long-term follow-up evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- •Chronic heart failure patients
- •Treated for heart failure according to current guidelines
- •≥ 18 years of age
- •Able to provide informed consent
排除标准
- •Reversible forms of acute heart failure (myocarditis)
- •Presence of severe aortic stenosis
- •Previous residency in a nursing home
- •Inclusion in a cardiac rehabilitation program on discharge
- •Chronic kidney disease stage ≥ 4
- •Planned dialysis in the next six months
- •Life expectancy < 1 year due to non-heart failure related reasons
- •Severe chronic obstructive pulmonary disease, GOLD ≥ III
- •Cognitive and/or mental problems interfering with the performance of daily measurements and data transmission
结局指标
主要结局
All-cause mortality
时间窗: Start of study to long-term follow-up (6.5 years).
All-cause mortality
次要结局
- days lost due to heart failure readmissions(Start of study to long-term follow-up (6.5 years).)
- days lost due to all readmissions(Start of study to long-term follow-up (6.5 years).)
- percentage of follow-up time spent in hospital for heart failure(Start of study to long-term follow-up (6.5 years).)
- percentage of follow-up time spent in hospital for all reasons(Start of study to long-term follow-up (6.5 years).)
- percentage of follow-up time lost to death or heart failure readmissions(Start of study to long-term follow-up (6.5 years).)
- days lost due to death or heart failure readmissions(Start of study to long-term follow-up (6.5 years).)
研究者
prof. dr. Paul Dendale
Prof. dr.
Hasselt University
相似试验
Enrolling By Invitation
1 期
Rollover Study From EXG-US-01Telomere Biology Disorders With Bone Marrow FailureNCT05868499Elixirgen Therapeutics, Inc.12
进行中（未招募）
不适用
Unraveling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma (TASMA) Extension StudySevere AsthmaNCT02975284Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)30
终止
3 期
A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs SyndromeRestless Legs SyndromeNCT03992196UCB Biopharma SRL10
已完成
不适用
Australian Trial in Acute Hepatitis C Recall StudyAcute Hepatitis CNCT02000063Kirby Institute50
Enrolling By Invitation
不适用
Long Term Follow-up Study of AAVAnc80-hOTOF Gene TherapyOtoferlin Gene-mediated Hearing LossNCT06696456Akouos, Inc.30