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Not yet recruiting NCT06583473

The Effectiveness of Integrated Interactive Digital Health Application and Telemonitoring in Patients with Heart Failure and Reduced Ejection Fraction

No phase Interventional Heart Failure Health Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interactive digital health application.
Who it may be relevant to
Registry conditions: Heart Failure, Health Behavior. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Patient Source: Patients discharged from the cardiology ward with heart failure. Intervention Group: Prior to discharge, patients will be provided with and instructed on how to use the "Intelligent Interactive Personal Management System for Heart Failure" as well as a "Bluetooth-enabled blood pressure monitor and scale for remote data transmission." Control Group: Patients will receive standard medical care. Assessment Method: The Health-Related Quality of Life Questionnaire (EQ-5D), Kansas City Cardiomyopathy Questionnaire (KCCQ-12), and Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) will be completed before discharge, and at 1 month, 6 months, and 12 months post-discharge. The average time to complete the questionnaires is 10-15 minutes. Additionally, cardiovascular events and readmission rates will be tracked and analyzed over a 1-year period.

Interventions

  • Behavioral Interactive digital health application
    The study program will provide an integrated interactive digital health application (LINE app on smartphones, incorporating information about biodata recording, health education, questionnaires, and online Q\&A)

Primary outcome measures

  • Heart failure re-hospitalization rate [Time frame: 1 Year]
  • Kansas City Cardiomyopathy Questionnaire [Time frame: 1 Year]
  • EQ-5D [Time frame: 1 Year]
  • FACIT-Sp-12 [Time frame: 1 Year]

Eligibility criteria

Inclusion criteria

Diagnosed with heart failure

Exclusion criteria

Inability to independently stand or get out of bed. Unstable condition

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06583473 · HFApp

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗