Effects of a Wed-based FRAIL-SM Program Among Patients With Heart Failure

NCT07068308 · tracked via the Priya Life Science Taiwan tracker

Sponsor

National Yang Ming Chiao Tung University

Phase

Not applicable

Started

2026-01-01

Last updated

2025-07-25

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

web-based FRAIL-SM program

web-based FRAIL-SM program: The 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage.

Study summary

This study aims to examine the effects of web-based FRAIL-SM (Family involvement, self-Regulation skills training, Autonomy, Information sharing and Linkage, Self-Management) on frailty, self-management behaviors and quality of life in patients with heart failure and their families' heart failure knowledge, confidence, strain, and quality of life. Patients are recruited with a convenience sampling from two medical centers in Taiwan. The web-based FRAIL-SM includes Family involvement, self-Regulation, Autonomy support, Information sharing and Linkage.

Eligibility

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

Patients criteria: Inclusion Criteria: 1. Aged above 20. 2. Diagnosed with heart failure or LVEF\<40%. 3. Clear consciousness, can communicate with Chinese and Taiwanese. 4. Consent to join in this study and have family partner. 5. Access to computer or smartphone 6. Meet one of the Study of Osteoporotic Fractures of frailty Exclusion Criteria: 1. Bed-ridden or unable to perform activities of daily living independently. 2. Diagnosed with cognitive, psychiatric disease, or major depression. 3. Acute disease condition e.g. infection or thrombosis. 4. Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia. 5. severe neurodegenerative or muscular diseases, e.g. parkinson's disease, arthritis. Family criteria: Inclusion criteria 1. Aged above 20. 2. Clear consciousness, can communicate with Chinese and Taiwanese. 3. Consent to join in this study and willing to accompany with patients. 4. Access to computer or smartphone Exclusion Criteria: 1. Bed-ridden or unable to perform activities of daily living independently. 2. Diagnosed with cognitive, psychiatric disease, or major depression. 3. Have employment relationship with patients

Primary outcome measure(s)

Changes in Frailty Assessment Scale for Heart Failure scores — baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline Frailty Assessment Scale for Heart Failure scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Frailty Assessment Scale for Heart Failure contains 15 items, each item use Likert scale four point scoring (0-3), the total scores ranged from 0 to 45, the higher scores indicate higher levels of frailty.
Changes in Dutch Heart Failure Knowledge Scale scores — baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline Dutch Heart Failure Knowledge Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Dutch Heart Failure Knowledge Scale contains 15 items. The total scores ranged from 0 to 15, the higher scores indicate higher levels of knowledge.
Changes in Self-Care of Heart Failure Index scores — baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline Self-Care of Heart Failure Index scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Self-Care of Heart Failure Index contains 22 items, three subscales: self-care maintenance, self-care management, self-care confidence. Each subscale scores ranged from 0 to 100, the higher scores indicate higher levels of self-care maintenance, self-care management, self-care confidence.
Changes in Minnesota Living with Heart Failure questionnaire scores — baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline Minnesota Living with Heart Failure questionnaire scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Minnesota Living with Heart Failure questionnaire contains 21 items, each item scores ranged from 0 to 5. The total socre ranged from 0 to 105, the higher scores indicate higher levels of impact on quality of life.

Trial sites (1)

Facility	City	Region	Status
National Yang Ming Chiao Tung University	Taipei	Taiwan

More National Yang Ming Chiao Tung University trials in Taiwan

Intrinsic Capacity, Resilience, and Meaning in Life in Community-Dwelling Midlife and Older Adults Enrolling by invitation

Alterations in Spiking Following Muscle Fatigue in Volleyball Players Starting soon

Kinematic Biofeedback on Gait Quality in Stroke Recruiting

Motion and EMG Analysis of the Forehand Topspin, Forehand Stroke, and Forehand Attack in Elite Table Tennis Players Recruiting

The Effects of fNIRS-based Neurofeedback Training on Balance and Gait in Parkinson's Disease Recruiting

Other trials for the same condition

Home-based Cardiac Rehabilitation With Spot-jogging Active, not recruiting

AI-Based Conversational Social Support for Older Adults With Heart Failure Recruiting

ECG Low Ejection Fraction Detection and Guiding in AI Navigated Treatment Era Enrolling by invitation

A Multi-center Cardiac PYP Scan Registry in Taiwan Recruiting

iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07068308 on ClinicalTrials.gov ↗ ← All trials in Taiwan