Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06583473
Enrollment
100
Registered
2024-09-04
Start date
2024-11-01
Completion date
2026-07-31
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior, Heart Failure

Keywords

Heart Failure, Interactive digital health application

Brief summary

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

BEHAVIORALInteractive 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)

Sponsors

Hsiao Fu-Chih
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosed with heart failure

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Heart failure re-hospitalization rate1 YearThe rate of heart failure re-hospitalization
Kansas City Cardiomyopathy Questionnaire1 YearThe 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.
EQ-5D1 YearThe 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).
FACIT-Sp-121 YearThe 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.

Contacts

Primary ContactFu-Chih Hsiao Doctor of Medicine
maniclone@gmail.com88633281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026