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临床试验/NCT02673073
NCT02673073Unknown2 期

Self-Awareness of Symptoms, Signs and Medical Compliance Using a Patient Diary in Heart Failure Management (AWARE-HF)

Seoul National University Bundang Hospital2 个研究点 分布在 1 个国家目标入组 1,220 人开始时间: 2016年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong-Ju Choi

MD, PhD

Seoul National University Bundang Hospital

研究点 (2)

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