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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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CHF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional, prospective, open-labled, comparative, randomized clinical trial.

Baseline group: standard medical treatment + using of mobile application for remote monitoring, base of self-controlling, 12 month.

Control group: standard medical treatment + base of self-controlling.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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baseline

standard medical therapy + using of mobile application + improving therapy

Group Type ACTIVE_COMPARATOR

mobile application "M-Cardio" based on android

Intervention Type COMBINATION_PRODUCT

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.

Control

standard medical therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No