About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
web-based FRAIL-SM program
BehavioralThe 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
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.
Other outcomes
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.
Sponsors and contacts
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