Heart Failure
Conditions
Keywords
frailty, heart failure, self-management, web-based frailty self-management program, knowledge, family caregiver, quality of life
Brief summary
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
BEHAVIORALweb-based FRAIL-SM program
The 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage.
Sponsors
National Yang Ming Chiao Tung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Frailty Assessment Scale for Heart Failure scores | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks | Changes from baseline Frailty Assessment Scale for Heart Failure scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Frailty Assessment Scale for Heart Failure contains 15 items, each item use Likert scale four point scoring (0-3), the total scores ranged from 0 to 45, the higher scores indicate higher levels of frailty. |
| Changes in Dutch Heart Failure Knowledge Scale scores | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks | Changes from baseline Dutch Heart Failure Knowledge Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Dutch Heart Failure Knowledge Scale contains 15 items. The total scores ranged from 0 to 15, the higher scores indicate higher levels of knowledge. |
| Changes in Self-Care of Heart Failure Index scores | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks | Changes from baseline Self-Care of Heart Failure Index scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Self-Care of Heart Failure Index contains 22 items, three subscales: self-care maintenance, self-care management, self-care confidence. Each subscale scores ranged from 0 to 100, the higher scores indicate higher levels of self-care maintenance, self-care management, self-care confidence. |
| Changes in Minnesota Living with Heart Failure questionnaire scores | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks | Changes from baseline Minnesota Living with Heart Failure questionnaire scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Minnesota Living with Heart Failure questionnaire contains 21 items, each item scores ranged from 0 to 5. The total socre ranged from 0 to 105, the higher scores indicate higher levels of impact on quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in World Health Organization Quality of Life - BREF (WHOQOL-BREF) scale scores | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks | Changes from baseline World Health Organization Quality of Life - BREF (WHOQOL-BREF) Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The WHOQOL-BREF scale contains 28 items, four dimensions. Each dimension scores ranged from 4 to 20, the higher scores indicate higher levels of quality of life. |
| Changes in Caregiver Strain Index scores | baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks | Changes from baseline Caregiver Strain Index scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Scale contains 13 items, the total scores ranged from 0 to 13, the higher scores indicate higher levels of strain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hospital Anxiety and Depression Scale scores | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks | Changes from baseline Hospital Anxiety and Depression Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Hospital Anxiety and Depression Scale contains 14 items, two subscales: anxiety and depression. Each subscale scores ranged from 0 to 21, the higher scores indicate higher levels of anxiety and depression. |
Countries
Taiwan
Contacts
Primary ContactAi-Fu Chiou, PhD
Outcome results
None listed