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

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Yang Ming Chiao Tung University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • web-based FRAIL-SM program

    Behavioral

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

Treatment groups

328 Participants
are divided into 2 treatment groups
Group A: wed-based FRAIL-SM programExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
2

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.

Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
3

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.

Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
4

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.

Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

Secondary outcomes

1

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.

Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
2

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.

Time frame
baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks

Other outcomes

1

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.

Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

Sponsors and contacts

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