Clinical trial NCT04591964: Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application
Official title: Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application: Open-labled Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: CHF
Keywords: Chronic heart failure
telemedicine
mobile health
mobile application
remote monitoring
Lead sponsor: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Sponsor class: OTHER_GOV
First posted: 2020-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause death
timeFrame: 12 month
measure: Recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
timeFrame: 12 month
Secondary outcomes:
measure: Quality of Life assesed Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ)
timeFrame: 12 month
measure: 6-minute walking test results
timeFrame: 12 month
measure: Nt-proBNP levels
timeFrame: 12 month
Other outcomes:
measure: Сommitment
timeFrame: 12 month
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Centre of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Study officials:
affiliation: Head of CHF department
name: Aigul Noruzbaeva, professor
role: STUDY_DIRECTOR
References: