Effects of a Wed-based FRAIL-SM Program Among Patients With Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: web-based FRAIL-SM program.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Effectiveness of a Wed-based FRAIL-SM Program Among Patients With Heart Failure
Overview
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.
Detailed 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.
Interventions
- Behavioral web-based FRAIL-SM program
The 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage.
Primary outcome measures
- Changes in Frailty Assessment Scale for Heart Failure scores [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
- Changes in Dutch Heart Failure Knowledge Scale scores [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
- Changes in Self-Care of Heart Failure Index scores [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
- Changes in Minnesota Living with Heart Failure questionnaire scores [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
Secondary outcome measures (2)
- Changes in World Health Organization Quality of Life - BREF (WHOQOL-BREF) scale scores [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
- Changes in Caregiver Strain Index scores [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks]
Eligibility criteria
Patients criteria:
Inclusion criteria
- Aged above 20.
- Diagnosed with heart failure or LVEF<40%.
- Clear consciousness, can communicate with Chinese and Taiwanese.
- Consent to join in this study and have family partner.
- Access to computer or smartphone
- Meet one of the Study of Osteoporotic Fractures of frailty
Exclusion criteria
- Bed-ridden or unable to perform activities of daily living independently.
- Diagnosed with cognitive, psychiatric disease, or major depression.
- Acute disease condition e.g. infection or thrombosis.
- Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
- severe neurodegenerative or muscular diseases, e.g. parkinson's disease, arthritis.
Family criteria:
Inclusion criteria
- Aged above 20.
- Clear consciousness, can communicate with Chinese and Taiwanese.
- Consent to join in this study and willing to accompany with patients.
- Access to computer or smartphone
Exclusion criteria
- Bed-ridden or unable to perform activities of daily living independently.
- Diagnosed with cognitive, psychiatric disease, or major depression.
- Have employment relationship with patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- National Yang Ming Chiao Tung University — Taipei
Identifiers
NCT: NCT07068308 · NYCU113069AE