A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Cell-Phone Intervention Arm
A standard cell phone system sent web-browser messages daily to ask about their weight and symptoms of heart failure. Participants received up to 3 daily messages 15 minutes apart at a time of their choosing for 90 days. Participants were given a mobile phone for the 90 day period and a weight scale.
干预措施: Cell Phone (Other)
Usual Care
Usual Care participants continued to receive care in the Heart Failure Clinic. All subjects were enrolled in the study for 90 days. Participants were given a weight scale.
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
- Usability survey(90 days)
- 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)
- Fatigue Visual Numeric(90 days)
- Heart Failure Self-Efficacy Scale-30(90 days)
- The Medical Outcome Study 36-Item Short Form(90 days)
研究者
Stuti Dang MD
Clinical Associate Professor
University of Miami