The Effectiveness of Integrated Interactive Digital Health Application and Telemonitoring in Patients with Heart Failure and Reduced Ejection Fraction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- FACIT-Sp-12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with heart failure
Exclusion Criteria
- •Inability to independently stand or get out of bed. Unstable condition
Arms & Interventions
Interactive digital health care
The "Intelligent Interactive Personal Management System for Heart Failure" and Bluetooth-enabled devices for remote monitoring of blood pressure and weight.
Intervention: Interactive digital health application (Behavioral)
Standard care
The control group will continue to receive standard medical care.
Outcomes
Primary Outcomes
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.
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.
Heart failure re-hospitalization rate
Time Frame: 1 Year
The rate of heart failure re-hospitalization
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Hsiao Fu-Chih
Doctor
Chang Gung Memorial Hospital