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

NCT ID: NCT06583473

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Health Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Interactive digital health application

Intervention Type 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)

Standard care

The control group will continue to receive standard medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Diagnosed with heart failure

Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hsiao Fu-Chih

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hsiao Fu-Chih

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Linkou Chang Gung Memorial Hospital

, ,

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fu-Chih Hsiao Doctor of Medicine

Role: CONTACT

88633281200 ext. 5225

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fu-Chih Hsiao Doctor of Medicine

Role: primary

88633281200 ext. 5225

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HFApp

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CHF Management Using Telemedicine
NCT00309764 COMPLETED NA
New Model of Care in Heart Failure
NCT03476590 COMPLETED NA