Family-based Frailty Self Management Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure

NCT05765721 | Completed

• 1 other identifier: YM111045EF
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled trial study aims to develop a frailty self-management model for heart failure patients, and to examine the effect of family-based frailty self-management program (FRAIL-SM) including Family involvement, self-Regulation, Autonomy support, Information sharing and Linkage on frailty, knowledge, self-care ability and quality of life in patients with heart failure and their family's strain, knowledge, confedence, and quality of life. Data is collected by a structural questionnaire including frailty, heart failure knowledge, self-care of heart failure, anxiety and depression, social support, and quality of life and physical indicators at baseline, 4 weeks, 8 weeks and 12 weeks after enrollment.

Conditions

Frailty; Quality of Life; Self-management

Keywords

Frailty; Quality of Life; self management; Heart failure; family-based program

Outcome Measures

Primary Outcomes (3)

• Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores

  Changes from baseline Frailty Assessment Scale for Heart Failure (FAS-HF) scores including three indicators: physical, Psychological and social , at 4 weeks, 8 weeks, 12 weeks. FAS-HF scale contains 15 items, each item use Likert scale five point scoring, the total scores ranged from 0 to 45,the higher scores indicate higher frailty.

  baseline, 4week, 8week, 12week

• Changes in The Minnesota living with heart failure questionnaire(MLHFQ) scores

  Changes from baseline Minnesota living with heart failure questionnaire at 4 weeks, 8 weeks, 12 weeks. The Minnesota living with heart failure questionnaire contains 21 questions regarding the effects of heart failure on patients' physical (eight questions),emotional (five questions) and general (eight questions) dimensions. The possible answer for each question ranges from 0(no) to 5(a lot), and the total score range is 0-105; a higher score indicates lower quality of life .

  baseline, 4week, 8week, 12week

• Changes in the Self-Care of Heart Failure Index scores

  Changes from baseline Self-Care of Heart Failure Index scores including three indicators: self-maintenance, self-management and self confidence , at 4 weeks, 8 weeks, 12 weeks. This scale contains 22 items, each item use Likert scale four point scoring, the total scores ranged from 22 to 88, the higher scores indicate better self-care.

  baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (6)

• Changes in symptoms distress scores

  baseline, 4week, 8week, 12week

• Changes in anxiety and depression scores

  baseline, 4week, 8week, 12week

• Changes in caregivers confidence of heart failure self care

  baseline, 4week, 8week, 12week

• Changes in The Caregiver Strain Index(CSI)

  baseline, 4week, 8week, 12week

• Changes in heart failure knowledge of caregivers

  baseline, 4week, 8week, 12week

Study Arms (2)

intervention group

EXPERIMENTAL

Patients in this group will receive a 8-week family-based frailty self-management program including: (1) one 20-30 minute individual consultation (teaching how to join the family-based frailty self-management program by using poster); (2) provided self-management booklet; (3) provided family-based frailty self-management program video through Line group meeting, once per two weeks ; (4) individual consultation through telephone follow-up once per week for 8 weeks

Behavioral: FRAIL-SM Program

Control group

NO INTERVENTION

Patients in this group maintain their daily life activities, and there is no intervention given.

Interventions

FRAIL-SM Program BEHAVIORAL

Patients in experimental group will receive a 8 week family-based frailty self-management program; patients in control group maintain their usual life activities.

intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥ 40 years.
• diagnosed by doctros with heart failure and in stable condition.
• clear consciousness, can communicate with Chinese and Taiwanese.
• consent to join in this study.
• have a smartphone or computer and be able to join social media
• have SOF score ≥ 1

You may not qualify if:

• were bed-ridden or unable to perform activities of daily living independently.
• diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
• in the acute stage of the disease, such as inflammation, infection, or vascular embolism
• with contraindications to exercise, such as those with uncontrolled arrhythmia, unstable heart rate, BP or PaO2.
• suffer from neurological, muscular, skeletal or rheumatoid diseases that are aggravated by exercise.
• aged ≥ 20 years.
• clear consciousness, can communicate with Chinese and Taiwanese.
• consent to join in this study with patients.
• have serious chronic diseases and need to dependent on others for daily living
• diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
• have an employment relationship with the patient

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (2)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Frailty; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Ai-Fu Chiou, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants are trained for being outcomes assessors in this study who did not know the allocation of participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients in the intervention group will receive an 8-week family-based frailty self-management program including:individual consultation, teaching how to do self-management by family-based frailty self-management video.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: November 16, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)