Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application (ERICA-HF)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    300
  • sponsor
    National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Updated on 3 May 2022
medical therapy
depression
myocardial infarction
infarct
chronic heart failure
nt-probnp

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.

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.

Details
Condition CHF
Treatment mobile application "M-Cardio" based on android
Clinical Study IdentifierNCT04591964
SponsorNational Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Last Modified on3 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note