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

October 7, 2024 updated by: Hsiao Fu-Chih

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fu-Chih Hsiao Doctor of Medicine
  • Phone Number: 5225 88633281200
  • Email: maniclone@gmail.com

Study Locations

        • Linkou Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Diagnosed with heart failure

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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)
No Intervention: Standard care
The control group will continue to receive standard medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure re-hospitalization rate
Time Frame: 1 Year
The rate of heart failure re-hospitalization
1 Year
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.
1 Year
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).
1 Year
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.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hsiao Fu-Chih

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

September 2, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFApp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the early phase after the diagnosis of HFrEF, self-monitoring of the blood pressure, pulse rate, and body weight at home, enhancement of the knowledge and self-awareness of the disease, and regular outpatient follow-up and health education are key elements in improving adherence to pharmacotherapies; and improving quality of holistic health care, including physiological, psychological, and social aspects.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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