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NCT Number: NCT06583473

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

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Health Behavior Heart Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with heart failure

Exclusion criteria

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

Treatment and study plan

Interactive digital health application

Behavioral

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 outcomes

  1. Heart failure re-hospitalization rate

    Time frame: 1 Year

    The rate of heart failure re-hospitalization

  2. Kansas City Cardiomyopathy Questionnaire

    Time frame: 1 Year

    The KCCQ-12 is a validated health status measure for patients with HF. It contains four subdomains: Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status. The mean of the four subdomain scores are presented as a summary score, with differences of 5 points or greater considered to be clinically important.

  3. EQ-5D

    Time frame: 1 Year

    The EQ-5D-5L is a widely used health status measure with two parts. The first part evaluates health across five dimensions: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN/DISCOMFORT, and ANXIETY/DEPRESSION, each with five response levels. This generates a health state profile, which can be assigned a summary index score based on societal preference weights, or "utilities," for calculating QALYs in health economics. Scores range from less than 0 (death or worse) to 1 (full health), with higher scores indicating better health utility. The second part of the questionnaire is a visual analogue scale (VAS) where patients rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health).

  4. FACIT-Sp-12

    Time frame: 1 Year

    The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp-12) is a 12-item scale designed to measure spiritual well-being in individuals with chronic illnesses. Possible scores range from 0 to 48, with higher scores reflecting greater spiritual wellbeing.

Study contacts

Contact information is provided by the study sponsor or research team.

Fu-Chih Hsiao Doctor of Medicine

CONTACT

[email protected]

88633281200 ext. 5225

Sponsors and collaborators

Lead sponsor

Hsiao Fu-Chih

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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