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

National Yang Ming Chiao Tung University

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Behavioral: web-based FRAIL-SM program

Study type: Interventional

Funder types: Other

Identifiers

NCT07068308

NYCU113069AE

Details and patient eligibility

About

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.

Full description

A randomized controlled trial is conducted. Subjects are selected using a convenience sampling and are randomly assigned to the intervention or control group by stratified randomization according to participation of post-acute care. Patients in the intervention group will receive an 8-week web-based FRAIL-SM program. Data is collected by researchers using a structural questionnaire including frailty, heart failure knowledge, self-care of heart failure, and quality of life and physical indicators such as levels of B-type natriuretic peptide, hemoglobin, hematocrit, albumin at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment.

Enrollment: 328 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients criteria:

Inclusion Criteria:

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

Exclusion Criteria:

1. Bed-ridden or unable to perform activities of daily living independently.
2. Diagnosed with cognitive, psychiatric disease, or major depression.
3. Acute disease condition e.g. infection or thrombosis.
4. Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
5. severe neurodegenerative or muscular diseases, e.g. parkinson's disease, arthritis.

Family criteria:

Inclusion criteria

1. Aged above 20.
2. Clear consciousness, can communicate with Chinese and Taiwanese.
3. Consent to join in this study and willing to accompany with patients.
4. Access to computer or smartphone

Exclusion Criteria:

1. Bed-ridden or unable to perform activities of daily living independently.
2. Diagnosed with cognitive, psychiatric disease, or major depression.
3. Have employment relationship with patients

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

328 participants in 2 patient groups

wed-based FRAIL-SM program

Experimental group

Description:

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.

Treatment:

Behavioral: web-based FRAIL-SM program

control group

No Intervention group

Description:

Patients in this group will receive usual care.