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临床试验/NCT05668000
NCT05668000已完成不适用

Self-Monitoring Using Mobile App for Reduction of Rehospitalization and Mortality in Heart Failure (SMART-HF)

Seoul National University Bundang Hospital14 个研究点 分布在 2 个国家目标入组 84 人开始时间: 2022年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
14
主要终点
HF symptom by questionnaire

研究概览

简要总结

The investigators developed a mobile health platform to self-management in HF. The aim of this study is to evaluate whether this smartphone app-based intervention can improve symptoms of HF when compared to usual care in HF patients.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20 years or older hospitalized for acute heart failure.
  • Patients who have obvious symptoms or sign of HF at admission
  • N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥400 pg/mL or brain natriuretic peptide (BNP) ≥100 pg/mL.
  • participants should be able to use smartphone well.

排除标准

  • Patients who have baseline systolic blood pressure <90 mmHg or resting heart rate <50 beats per minutes
  • Patients who cannot use smartphone
  • Patients who had cardiac implantable electronic device will be excluded

结局指标

主要结局

HF symptom by questionnaire

时间窗: 4 weeks

The degree of dyspnea will be evaluated by questionnaire. Range: 0(worst)-10(best)

HF symptom by application scores.

时间窗: 4 weeks

the mean value of scores of dyspnea, fatigue, and ankle edema stored in app by participants will be evaluated. Range 0(no symptom) - 3(severe symptom)

次要结局

  • Composite outcome(4 weeks)
  • Application satisfaction score(4 weeks)
  • change in body water composition f(4 weeks)

研究者

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

Dong-Ju Choi

Professor

Seoul National University Bundang Hospital

研究点 (14)

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