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

National Yang Ming Chiao Tung University

Status: Completed

Conditions: Quality of Life; Self-management; Frailty

Treatments: Behavioral: FRAIL-SM Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05765721

YM111045EF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients 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

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.

Caregivers Inclusion Criteria:

1. aged ≥ 20 years.
2. clear consciousness, can communicate with Chinese and Taiwanese.
3. consent to join in this study with patients.

Caregivers Exclusion Criteria:

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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232 participants in 2 patient groups

intervention group

Experimental group

Description:

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

Treatment:

Behavioral: FRAIL-SM Program

Control group

No Intervention group

Description:

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