Self-Awareness of Symptoms, Signs and Medical Compliance Using a Patient Diary in Heart Failure Management (AWARE-HF)
试验速览
- 阶段
- 2 期
- 入组人数
- 1,220
- 试验地点
- 2
- 主要终点
- Composite of all-cause death or rehospitalization
研究概览
简要总结
Before a HF patient gets maximally decompensated and visit emergency department, most patients experience symptoms and signs of "on-going decompensation (or pre-decompensation)", which may not be noticed by the patients. If HF patients were aware of symptoms and signs of ADHF and received early intervention to stop the process of "on-going decompensation (or pre-decompensation)", it would be possible to reduce the rate of hospitalization for ADHF or death. Thus, self-awareness and self-examination of heart failure symptoms, signs and medical compliance using a patient diary in HF management may improve the outcomes in chronic stable HF patients. A patient diary with 6 parameters can serve this purpose: body weight, blood pressure, heart rate, drug compliance expressed as number of remaining pills of previous day, edema grade, and dyspnea grade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients who are 18 years or older
- •Patients admitted for acute heart failure and scheduled for discharge after medical stabilization
- •Chronic stable heart failure patients with a history of hospitalization for AHF
排除标准
- •Patients with limited cognitive function who cannot not perform self-recording (in case that the patient has a family member who can perform the recording, the patient can be rerolled)
结局指标
主要结局
Composite of all-cause death or rehospitalization
时间窗: 1 year
Data on primary and secondary measures will be collected a trained study coordinator, using a standardized case report form.
次要结局
- admission for acute heart failure(1 year)
- cardiovascular death(1 year)
- all-cause death(1 year)
- drug compliance(1 year)
研究者
Dong-Ju Choi
MD, PhD
Seoul National University Bundang Hospital
