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

NCT ID: NCT05765721

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2024-10-01

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.

Detailed Description

This 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, self-care ability and quality of life in patients with heart failure and their family's strain and quality of life. Patients are recruited with a convenience sampling from two medical centers in Taiwan.

A cross-sectional study is adopted to examine the associated factors of frailty and self-management in patients with heart failure. Besides, a qualitative research with face-to-face individual interview is conducted to understand the experience of frailty and self-management in patients with heart failure and their families. Then, a randomized controlled trial is conducted. Subjects are selected using a convenience sampling and are randomly assigned to the intervention or control group. Patients in the intervention group will receive an 8-week family-based frailty self-management program. 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 such as levels of B-type natriuretic peptide, hemoglobin, hematocrit, albumin at baseline, 4 weeks, 8 weeks and 12 weeks after enrollment. Data analysis includes descriptive statistics, Pearson correlation coefficient, independent t-test, chi-square, one-way ANOVA, multiple regression, structural equation modeling, and generalized estimating equation.

Conditions

Frailty; Quality of Life; Self-management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention group

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

Group Type: EXPERIMENTAL

FRAIL-SM Program

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FRAIL-SM Program

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. aged ≥ 40 years.

2. diagnosed by doctros with heart failure and in stable condition.

3. clear consciousness, can communicate with Chinese and Taiwanese.

4. consent to join in this study.

5. have a smartphone or computer and be able to join social media

6. have SOF score ≥ 1

1. aged ≥ 20 years.

2. clear consciousness, can communicate with Chinese and Taiwanese.

3. consent to join in this study with patients.

Exclusion Criteria

1. were bed-ridden or unable to perform activities of daily living independently.

2. diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression

3. in the acute stage of the disease, such as inflammation, infection, or vascular embolism

4. with contraindications to exercise, such as those with uncontrolled arrhythmia, unstable heart rate, BP or PaO2.

5. suffer from neurological, muscular, skeletal or rheumatoid diseases that are aggravated by exercise.

1. have serious chronic diseases and need to dependent on others for daily living

2. diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression

3. have an employment relationship with the patient

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ai-Fu Chiou, PhD

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Locations

Taichung Veterans General Hospital

Taichung, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

YM111045EF

Identifier Type: -

Identifier Source: org_study_id