NCT05765721

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: National Yang Ming Chiao Tung University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-03-13
• Last updated: 2025-07-10

Locations

2 sites across 1 country: Taiwan