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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT07068308
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief 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.

Detailed Description

A randomized controlled trial is conducted. Subjects are selected using a convenience sampling and are randomly assigned to the intervention or control group by stratified randomization according to participation of post-acute care. Patients in the intervention group will receive an 8-week web-based FRAIL-SM program. Data is collected by researchers using a structural questionnaire including frailty, heart failure knowledge, self-care of heart failure, and quality of life and physical indicators such as levels of B-type natriuretic peptide, hemoglobin, hematocrit, albumin at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-07-06
• Study First Submitted QC: 2025-07-06
• Study First Posted: 2025-07-16
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Study Start: 2026-01-01
• Primary Completion: 2027-05-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 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 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 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.

Secondary Outcome Measures

Name	Time	Method
Changes in World Health Organization Quality of Life - BREF (WHOQOL-BREF) scale scores	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks	Changes from baseline World Health Organization Quality of Life - BREF (WHOQOL-BREF) Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The WHOQOL-BREF scale contains 28 items, four dimensions. Each dimension scores ranged from 4 to 20, the higher scores indicate higher levels of quality of life.
Changes in Caregiver Strain Index scores	baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks	Changes from baseline Caregiver Strain Index scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Scale contains 13 items, the total scores ranged from 0 to 13, the higher scores indicate higher levels of strain.

Trial Locations

Locations (1)

National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan