Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application: Open-labled Randomized Clinical Trial.
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
研究概览
简要总结
CHF is a most wild-spread and prognostically poor outcome most of cardiovascular and other disease. Despite of significant progress in treatment of CHF for the last years, death from this pathology stayed very high, reaching 60% for men, 45% for women during the 5 years after establishing diagnosis. The purpose of treatment is creating "seamless" system of care the whole continuum stretch CHF, in this connection, the particular relevance take in creating of new way and strategy with IT-technology mHealth. On the whole, mHealth application potentially suggest economic efficiency solution with continuous access for symptoms monitoring, stimulation of patients to self-servicing, self-controlling and achieving better results compare with optimal medical therapy. So, remote monitoring of patients on the base of mobile application must improve clinical and economic efficiency of medical care received.
In trial will be studied efficiency of using mobile application for remote monitoring of patients with ischemic etiology HF, also quality of life, commitment to therapy and prognosis (frequency of cardiovascular poor outcomes). Clinical indicators and tests (Quality of Life Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale, 6-minute walking test) will be evaluated in the beginning of the trial and repeatly after 1 year.
Trial financed by Kyrgyz Republic Ministry of Education and Science.
详细描述
It is single-centered, open-labled, comparative, prospective, randomized clinical trial, intended to study the benefits, if that's have, 12-month remote monitoring with using mobile application based on chronic heart failure clinical flow of 200 patients with coronary heart disease.
Participants will seen twice: screening, initial randomization, last 12 month, during which will be evaluated clinical and laboratory indicators. At the time of first screening visit will be singed informed consent. In the department of chronic heart failure of National Center of Cardiology and Internal Medicine named by M. Mirrakhimov the patients will be laboratory and clinical-instrumentary examined and have been teaching for using mobile application, basics of self-servicing and self-controlling. Participants, meeting all inclusion criteria, will come back for randomization during the hospitalization or just to standard medical therapy, or to standard medical therapy and remote monitoring with mobile application. In active comparator patients besides of standard medical therapy will use mobile application twice a week, if necessary every day, also foreseen two-way feedback with the coordinating doctor and online chat on WhatsApp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or over (not older 70 y.o)
- •Participant willing and able to give informed consent
- •Documented Coronary artery disease (CAD): either angio-graphically documented CAD or a previous history of myocardial infarction/angina.
- •Verified heart failure functional class III (Nt-proBNP levels, 6-min walking test).
- •Receiving basic therapy for CAD and chronic heart failure (CHF).
- •Able (in the investigators opinion) and willing to comply with all study requirements.
排除标准
- •Cognitive impairments.
- •Unstable course of CAD.
- •Acute heart failure or CHF decompensation.
- •Malignancy (receiving active treatment) or other life threatening disease.
- •Renal dysfunction (stage 3B or worse).
- •Thyroid dysfunction.
- •Pregnancy/lactating females.
- •Any other reason considered inappropriate by a study physician.
- •Participants who have participated in any other clinical trial within the previous 30 days
结局指标
主要结局
Recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
时间窗: 12 month
fixation of reaching the primary endpoint recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
All-cause death
时间窗: 12 month
fixation of reaching the primary endpoint All-cause death
次要结局
- Quality of Life assesed Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ)(12 month)
- Nt-proBNP levels(12 month)
- 6-minute walking test results(12 month)
研究者
Akmaral Rustambekovna
Researcher in department of Chronic Heart Failure
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov