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

NCT07068308 | Not Yet Recruiting

• 1 other identifier: NYCU113069AE
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

frailty; heart failure; self-management; web-based frailty self-management program; knowledge; family caregiver; quality of life

Outcome Measures

Primary Outcomes (4)

• Changes in Frailty Assessment Scale for Heart Failure scores

  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.

  baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

• Changes in Dutch Heart Failure Knowledge Scale scores

  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.

  baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

• Changes in Self-Care of Heart Failure Index scores

  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.

  baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

• Changes in Minnesota Living with Heart Failure questionnaire scores

  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.

  baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

Secondary Outcomes (2)

• Changes in World Health Organization Quality of Life - BREF (WHOQOL-BREF) scale scores

  baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

• Changes in Caregiver Strain Index scores

  baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks

Other Outcomes (1)

• Changes in Hospital Anxiety and Depression Scale scores

  baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

Study Arms (2)

wed-based FRAIL-SM program

EXPERIMENTAL

Patients in the intervention group will receive an 8-week web-based FRAIL-SM program including family involvement, self-regulation, autonomy support, information sharing and linkage.

Behavioral: web-based FRAIL-SM program

control group

NO INTERVENTION

Patients in this group will receive usual care.

Interventions

web-based FRAIL-SM program BEHAVIORAL

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

wed-based FRAIL-SM program

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged above 20.
• Diagnosed with heart failure or LVEF\<40%.
• Clear consciousness, can communicate with Chinese and Taiwanese.
• Consent to join in this study and have family partner.
• Access to computer or smartphone
• Meet one of the Study of Osteoporotic Fractures of frailty

You may not qualify if:

• Bed-ridden or unable to perform activities of daily living independently.
• Diagnosed with cognitive, psychiatric disease, or major depression.
• Acute disease condition e.g. infection or thrombosis.
• Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
• severe neurodegenerative or muscular diseases, e.g. parkinson's disease, arthritis.
• Family criteria:
• Aged above 20.
• Clear consciousness, can communicate with Chinese and Taiwanese.
• Consent to join in this study and willing to accompany with patients.
• Access to computer or smartphone
• Bed-ridden or unable to perform activities of daily living independently.
• Diagnosed with cognitive, psychiatric disease, or major depression.
• Have employment relationship with patients

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Heart Failure; Frailty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ai-Fu Chiou, PhD

CONTACT

886-2-28267354; afchiou@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 25, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)