NCT04591964

Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application

Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application: Open-labled Randomized Clinical Trial.

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• CHF

Interventions

Type	Name	Description
COMBINATION_PRODUCT	mobile application "M-Cardio" based on android	Mobile apllication "M-Cardio" (android) for remote monitoring of patients with CHF developed on algorithms of clinical indicators, that's give us to evaluate current condition of patient, depends from quantity points of abnormals higher or lower threshold values, with automatically notification for doctor and patient for timely medical service.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-06-01
• Completion: 2023-12-31
• First posted: 2020-10-19
• Last updated: 2022-04-13

Locations

1 site across 1 country: Kyrgyzstan