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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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wed-based FRAIL-SM program

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.

Group Type EXPERIMENTAL

web-based FRAIL-SM program

Intervention Type BEHAVIORAL

The 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage.

control group

Patients in this group will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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web-based FRAIL-SM program

The 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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. 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:

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No