Clinical trial NCT04991857: Technology-based Family-centered Empowerment Program for Heart Failure (T-FAME-HF)
Official title: The Effects and Cost-effectiveness of a Technology-based Family-centered Empowerment (T-FAME) Program on Health and Health Service Utilization Outcomes of Post-discharged Patients With Advanced Heart Failure: A Sequential Mixed Method Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Telerehabilitation
Self Care
Empowerment
Disease Management
Keywords: Heart Failure
Telerehabilitation
Self Care
Empowerment
Disease Management
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2021-08-05
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Heart failure (HF) is a complex clinical syndrome characterized by inefficient myocardial pumping with signs of pulmonary and systemic congestion. Its progressively deteriorating trajectory punctuated by episodes of acute disease decompensation, not only compromises patients' health-related quality of life (HRQL), but also causes a hospitalization epidemic. Indeed, this clinical cohort is characterized by exceptionally high readmission rate of 25% and 50% within 4 weeks and 6 months, respectively, with ineffective self-care being as the most prominent modifiable risk factor. Effective transitional care is crucial to enhance the patient outcomes and control the economic impact. However, the concerned service in Hong Kong is rather under-developed due to the human resource burden and inadequate integration of the primary and tertiary healthcare systems. In fact, family support is of utmost important to support the HF patients in the post-discharge period. Together with the advance in E-health intervention, this study aims to evaluate the effects and cost-effectiveness of a technology-based family-centered empowerment program (T-FAME) to enhance the self-care and post-discharge outcomes of this clinical cohort.

Detailed description: The aim of this study is to investigate the effects of the technology-based family-centered empowerment program for heart failure (T-FAME-HF) on hospital readmission, mortality, event-free survival, HF-related self-care, family functioning and HRQL among patients admitted with HF. The study targets to recruit 270 participants in local hospitals in total.

The T-FAME-HF is a 16-week program adopts a hybrid approach to combine nurse-led home visits, an Apps, tele-care and optimized family support to enhance the post-discharge disease management, disease monitoring, and patients' access to the nurse, and telephone visits. The Program includes 3 four-week phases (1st - 4th; 5th - 8th; 9th - 12th week), which followed by 2 bi-weekly telephone visits. Each phase is designated with a specified goal of care to guide the disease management activities. Commenced with the home visit by the team nurse for each phase, patients' condition and self-care will be assessed. A goal-setting approach will be used to enhance disease monitoring, symptom recognition and response, and treatment compliance. The T-FAME Apps supports the prescribed actions for goal attainment by facilitating: i) BP and symptom monitoring with provision of corresponding health advice, ii) nurses' disease monitoring, iii) video-based training on knowledge and skills, iv) easy access to nurse through real-time chatroom, and v) weather and air quality alert. A blood pressure monitor device will be provided to support the health monitoring. After the 3rd phase, the nurse will monitor goal-attainment via tele-care.

For patients who assigned into the control group will receive a HF education program, the care dyad will receive a 16-week HF education program that comprises a home visit by another team nurse, five bi-weekly online training on self-care through videos on Whatapps/ WeChat with two subsequent telephone follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients consecutively admitted with a primary diagnosis of HF according to the Framingham criteria will be recruited. Eligible patients will be Chinese over 18 year-old, to be discharged home and living with family, patient/ family are using Smart Phone, and be communicable with the research team.

Exclusion Criteria:

* Those who are awaiting revascularization, cardiac resynchronization or heart transplant, and those with end-stage renal disease relying on hemodialysis rather than HF medications, to regulate fluid volume, will be excluded.

Primary outcomes:
measure: Self-Care Heart Failure Index (SCHFI, v.7.2)
timeFrame: Baseline
measure: Self-Care Heart Failure Index (SCHFI, v.7.2)
timeFrame: 8th week
measure: Self-Care Heart Failure Index (SCHFI, v.7.2)
timeFrame: 16th week
measure: Self-Care Heart Failure Index (SCHFI, v.7.2)
timeFrame: 24th week
measure: Self-Care Heart Failure Index (SCHFI, v.7.2)
timeFrame: 32th week
measure: Self-Care Self-Efficacy Scale (SCSE)
timeFrame: Baseline
measure: Self-Care Self-Efficacy Scale (SCSE)
timeFrame: 8th week
measure: Self-Care Self-Efficacy Scale (SCSE)
timeFrame: 16th week
measure: Self-Care Self-Efficacy Scale (SCSE)
timeFrame: 24th week
measure: Self-Care Self-Efficacy Scale (SCSE)
timeFrame: 32th week
measure: Minnesota Living with Heart Failure (MLHF) questionnaire
timeFrame: Baseline
measure: Minnesota Living with Heart Failure (MLHF) questionnaire
timeFrame: 8th week
measure: Minnesota Living with Heart Failure (MLHF) questionnaire
timeFrame: 16th week
measure: Minnesota Living with Heart Failure (MLHF) questionnaire
timeFrame: 24th week
measure: Minnesota Living with Heart Failure (MLHF) questionnaire
timeFrame: 32th week
measure: The EuroQoL-5-D instruments
timeFrame: Baseline
measure: The EuroQoL-5-D instruments
timeFrame: 8th week
measure: The EuroQoL-5-D instruments
timeFrame: 16th week
measure: The EuroQoL-5-D instruments
timeFrame: 24th week
measure: The EuroQoL-5-D instruments
timeFrame: 32th week
measure: Family Assessment Device Questionnaire - Global Family Function Subscale
timeFrame: Baseline
measure: Family Assessment Device Questionnaire - Global Family Function Subscale
timeFrame: 8th week
measure: Family Assessment Device Questionnaire - Global Family Function Subscale
timeFrame: 16th week
measure: Family Assessment Device Questionnaire - Global Family Function Subscale
timeFrame: 24th week
measure: Family Assessment Device Questionnaire - Global Family Function Subscale
timeFrame: 32th week
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine, PoK Oi Hospital
Study officials:
affiliation: The University of Hong Kong
name: Doris Sau Fung YU, PhD
role: PRINCIPAL_INVESTIGATOR
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