Telemonitoring Program With Electronic Alerts to Improve Outcomes in the Vulnerable Phase After Hospitalization for Heart Failure: A Pragmatic Clinical Trial TREAT - Vulnerable HF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Self-care behavior
研究概览
简要总结
This pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an electronic alert system compared to standard treatment on the perception of self-care in patients after hospitalization for decompensated HF at 3 months post-discharge. And secondarily to evaluate its impact on clinical events, NT-proBNP and efficacy and safety to facilitate the use and titration of the recommended drugs in patients with reduced ejection fraction at 90 days.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Hospitalized for acute heart failure (regardless of the level of left ventricular ejection fraction) within 24 hours of discharge, or with a history of hospitalization for acute HF within 10 days prior to randomization.
- •Own a smartphone (Smartphone) with internet Ability to speak and read Spanish.
- •Residence in the metropolitan area of Buenos Aires
排除标准
- •Pregnancy
- •Alcohol or drug abuse
- •Kidney failure in hemodialysis,
- •Inability to use the app (Ex: cognitive impairment, lack of social support, lack of ability to communicate)
- •Active cancer
- •Life expectancy less than 1 year
- •Candidates for care home or institutional end of life
- •Severe psychiatric illness
- •Planned cardiac surgery
- •Patient unable or unwilling to give informed consent to participate.
结局指标
主要结局
Self-care behavior
时间窗: 90 days
The EHFScBS scale will be used. It consists of a self-administered questionnaire with 12 items addressing various aspects of patient self-care. Each item is scored from 1 (completely agree/always) to 5 (completely disagree/never). The overall score can range from 12 (best self-care) to 60 (worst self-care)
次要结局
- Quality of life(90 days)
- Medication adherence(90 days)
- Time to achieve the use of Guideline-Directed Medical Therapy(90 days)
- First readmission for heart failure(90 days)
- NT pro BNP(90 days)
- Total number of readmissions for heart failure(90 days)
- Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy(90 days)
研究者
Lucrecia Maria Burgos
Unit coordinator
Instituto Cardiovascular de Buenos Aires