Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Change in NYHA class
研究概览
简要总结
Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized as a growing epidemic. Digital health interventions are the most recent iteration of an effort to promote individualized outpatient care through positive behaviour change theory. The UHN team has developed a highly automated and user-centered smartphone-based system, Medly, which allows for the telemonitoring of patients diagnosed with heart failure. The purpose of this study will be two-fold: 1) to determine if the introduction of Medly within two weeks of discharge will improve self-care management, quality of life, and clinical status, 2) to assess whether Medly will lead to a potential reduction in 30 day readmission rates amongst HF patients in the Toronto Central Local Health Integration Network (TC LHIN), without increasing the average length of stay or visits to the emergency department. These parameters will be measured as secondary outcomes.
详细描述
Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized as a growing epidemic. Digital health interventions are the most recent iteration of an effort to promote individualized outpatient care through positive behaviour change theory. The UHN team has developed a highly automated and user-centered smartphone-based system, Medly, which allows for the telemonitoring of patients diagnosed with heart failure
Patients with heart failure will be provided with a smartphone and commercial home medical devices, such as a blood pressure monitor and weight scale. The measurements from the medical devices will be automatically sent to the smartphone, and from there to a data server at the hospital for analysis and storage. Both clinicians and patients will be able to access these data and will be sent alerts by the system if the measurements are outside of the normal range. The system will be evaluated through interviews and comparing outcomes between the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Adults (18 years or older)
- •Hospitalization for decompensated HF > 48 hours
- •Patient speaks and reads English adequately to provide informed consent and understand the text prompts in the application (or has an informal caregiver who can translate for them)
- •Ability to comply with using Medly (ex. able to stand on the weight scale, able to answer symptom questions, etc.)
排除标准
- •Dementia or uncontrolled psychiatric illness
- •Residents of long-term care facilities
- •Terminal diagnosis of any health condition with a life expectancy < 1 year
- •Patients who will require inpatient rehabilitation after discharge
- •Participating in another clinical trial that may confound the results
研究组 & 干预措施
Control
Standard of care: Control groups will receive standard medical care when discharged from hospital, including discharge instructions, home medications as well as follow-up in a heart failure clinic or with a primary care doctor.
Telemonitoring (Medly)
Medly is a smartphone application allows heart failure (HF) patients to measure and record their daily weight, blood pressure (BP), heart rate, and self-reported symptoms. This monitoring information is then transmitted wirelessly to a data server where an algorithm is used to generate an alert to a healthcare provider as necessary. The patient also receives an automated self-care message based on their measurements and reported symptoms.
干预措施: Medly (Device)
结局指标
主要结局
Change in NYHA class
时间窗: Baseline, 1 month, 3 months
Change in NYHA class
Compliance with Medly utilization
时间窗: 3 months
Ability to adhere to Medly program
Change in quality of life
时间窗: Baseline, 3 months
Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and EuroQol (EQ5D)
Change in self-care of health failure
时间窗: Baseline, 3 months
Change in self-care of health failure as measured by the Self-Care of Heart Failure Index (SCHFI)
Change BNP/NT-pro BNP levels
时间窗: Baseline, 1 month, 3 months
Change BNP/NT-pro BNP levels
次要结局
- Hospital length of stay(0 - 3 months)
- 30-day HF readmission rate(1 month, 3 months)
- Number of visits to the emergency department(0 - 3 months)