Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application
ERICA-HF
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2021
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 13, 2022
April 1, 2022
1.4 years
September 24, 2020
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
All-cause death
fixation of reaching the primary endpoint All-cause death
12 month
Recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
fixation of reaching the primary endpoint recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
12 month
Secondary Outcomes (3)
Quality of Life assesed Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ)
12 month
6-minute walking test results
12 month
Nt-proBNP levels
12 month
Other Outcomes (1)
Сommitment
12 month
Study Arms (2)
baseline
ACTIVE COMPARATORstandard medical therapy + using of mobile application + improving therapy
Control
NO INTERVENTIONstandard medical therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Centre of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Bishkek, 720001, Kyrgyzstan
Study Officials
- STUDY DIRECTOR
Aigul Noruzbaeva, professor
Head of CHF department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher in department of Chronic Heart Failure
Study Record Dates
First Submitted
September 24, 2020
First Posted
October 19, 2020
Study Start
January 1, 2021
Primary Completion
June 1, 2022
Study Completion
December 31, 2023
Last Updated
April 13, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share