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临床试验/NCT02935439
NCT02935439已完成不适用

A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure

University of Miami2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Self-Efficacy for Managing Chronic Disease

研究概览

简要总结

The purpose of this research study is to learn about the use of a cell phone for monitoring patients with heart failure. Participants will be asked questions about their heart failure daily and participants will need to answer them. The investigator will try to assess if the questions are easily understood by the participants. The investigator will also assess if the phone-based system for monitoring is easy to use by the participants. The investigator will also assess if the daily questions and interactions increase the self-efficacy, knowledge, and quality of life of participants related to their heart failure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Have a diagnosis of heart failure
  • Have an anticipated survival ≥ 6 months
  • Receive care at the University of Miami or Jackson Healthcare system
  • 18 years or older
  • Able to communicate in English and/or Spanish
  • Able to operate a cell phone, read, understand, and respond to the questions on the cell phone, and are able to use the weight scale.

排除标准

  • Previous history of unstable coronary syndromes
  • History of end-stage heart failure or heart transplantation

结局指标

主要结局

Self-Efficacy for Managing Chronic Disease

时间窗: 90 days

This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Well-validated scale rating patient's confidence in managing chronic illness. It covers several areas of chronic diseases including symptom control, role functions, emotional functioning, and communicating with physicians. The English version has 6-items, while the Spanish version has 4-items.16 Using a Likert scale with item scores ranging from 1 to 10; scale score is the mean of the items.

次要结局

  • European Heart Failure Self-Care Behavior Scale(90 days)
  • Minnesota Living with Heart Failure Questionnaire(90 days)
  • Health Distress Scale(90 days)
  • Communication with Physicians(90 days)
  • Shortness of Breath Visual Numeric(90 days)
  • Dutch Heart Failure Knowledge Scale(90 days)
  • The Medical Outcome Study 36-Item Short Form(90 days)
  • Fatigue Visual Numeric(90 days)
  • Heart Failure Self-Efficacy Scale-30(90 days)
  • Usability survey(90 days)

研究者

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

Stuti Dang MD

Clinical Associate Professor

University of Miami

研究点 (2)

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