A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
研究概览
简要总结
This is a randomized controlled trial of telemonitoring vs usual care provided by home care agencies for patients with heart failure.
The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent care visits, unscheduled physician appointments, Emergency Room visits in patients with heart failure over the 60 day post hospitalization period.
详细描述
A 60 day stratified, randomized clinical trial of a home-based telemonitoring system (TEP) vs. usual home-care with educational package (EP). Both Groups will receive intensive patient education and primary care physicians will be prompted to adhere to heart failure management guidelines. The study will be conducted on 100 patients receiving home care nursing services post-hospital discharge.
Each participant will be randomized in equal amounts to treatment (TEP) or no treatment (EP).
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Failure (primary or secondary) diagnosis regardless of ejection fraction (EF) and New York Heart Association (NYHA) class II- IV at the time of Home Health Care (HHC) admission and HHC services initiated following a hospital stay
排除标准
- •Inability to stand on a scale, weight over 500 pounds, unable to hear and/or see, or no working land line phone in the residence.
- •Additional exclusion criteria were: patients with severe ischemic heart disease, Myocardial Infarction (MI) and/or Coronary artery bypass graft surgery(CABG) in the last 6 weeks, severe uncorrected valvular disease, home inotropic therapy, severe lung disease (oxygen dependent), active cancer, uncorrected thyroid disease, AIDS, or end stage renal disease on dialysis.
结局指标
主要结局
The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
时间窗: Participants were followed for the duration of home care services up to 12 months
Median time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED
次要结局
- Kansas City Cardiomyopathy Questionaire(Participants were followed for the duration of home care services up to 12 months)