跳至主要内容
临床试验/NCT03452683
NCT03452683撤回不适用

The Use of a Symptom and Weight e-Diary Among Patients With Heart Failure

University of California, San Francisco2 个研究点 分布在 1 个国家开始时间: 2018年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in Health Care Utilization

研究概览

简要总结

The purpose of this study is to determine the efficacy and feasibility of using a smartphone application to monitor symptoms and weight in patients with advanced heart failure.

详细描述

Attention to symptoms of heart failure and weight gain are central tenets in heart failure patient education and self-care. A key self-care skill for heart failure patients is the early detection of subtle changes in symptoms. Daily diary use can be one method for patients to acknowledge and attend to their symptoms. This study is examining if the use of a diary in the form of an app on a mobile phone will improve patient outcomes. Participants will be randomized to one of two groups-- usual care or the Movn mobile application. Participants randomized to the mobile app will be asked to record their weight and any symptoms every day over the course of two months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • At least 18 years old
  • History of symptomatic heart failure (Class III or IV)
  • Owns a smartphone or tablet compatible with the Movn mobile application

排除标准

  • Cognitive impairment
  • Lack of English proficiency/literacy
  • Clinically unstable (decompensated heart failure NYHA class 3-4; unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm, or symptomatic anemia; active infection; uncontrolled blood pressure: resting diastolic higher than 100 mmHg, systolic greater than 180 mmHg; unstable angina, 2nd or 3rd degree heart block; or uncontrolled high grade exercise-induced ventricular ectopy or hemodynamically unstable)

研究组 & 干预措施

Usual Care

No Intervention

Participants randomized to the Usual Care arm will receive educational handouts.

Movn Mobile App

Experimental

Participants randomized to the Movn Mobile App arm will have the Movn app downloaded to their cell phone. Participants will enter in their weight and symptoms into the app every day.

干预措施: Movn Mobile App (Behavioral)

结局指标

主要结局

Change in Health Care Utilization

时间窗: Health Care Utilization will be measured at two timepoints-- baseline and month 3.

Health Care Utilization will be measured by a questionnaire that asks about number of office visits, emergency room visits, and hospitalization in the last 60 days.

次要结局

  • Quality of Life(Quality of life will be measured at two timepoints-- baseline and month 3.)
  • Depression(Depression will be measured at baseline and month 3.)
  • Satisfaction with the app(Satisfaction with the app will be measured at month 3.)

研究者

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

Linda Park

Assistant Professor

University of California, San Francisco

研究点 (2)

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