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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wed-based FRAIL-SM program | Experimental | 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. |
|
| control group | No Intervention | Patients in this group will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| web-based FRAIL-SM program | Behavioral | The 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Frailty Assessment Scale for Heart Failure scores | 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. | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
| Changes in Dutch Heart Failure Knowledge Scale scores | 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. | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
| Changes in Self-Care of Heart Failure Index scores | 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. | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
| Changes in Minnesota Living with Heart Failure questionnaire scores | 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. | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in World Health Organization Quality of Life - BREF (WHOQOL-BREF) scale scores | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hospital Anxiety and Depression Scale scores | 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. | baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
Patients criteria:
Inclusion Criteria:
Exclusion Criteria:
Family criteria:
Inclusion criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ai-Fu Chiou, PhD | Contact | 886-2-28267354 | afchiou@nycu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Yang Ming Chiao Tung University | Taipei | 112 | Taiwan |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
| Changes in Caregiver Strain Index scores | 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. | baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks |