NCT04991857Active, not recruitingNot Applicable

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

The University of Hong Kong1 site in 1 country270 target enrollmentStarted: September 19, 2021Last updated: December 17, 2025

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: The University of Hong Kong
Enrollment: 270
Locations: 1
Primary Endpoint: Minnesota Living with Heart Failure (MLHF) questionnaire

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Supportive Care
Masking: Single (Outcomes Assessor)

Masking Description

It is a single-blind study. A research assistant (RA1) will identify eligible patients (participants) by record review, invite their participation and obtain their informed consent. After recruiting the participants, simple randomization will be conducted using a computer-generated sequence by 2-stage block randomization (block size of 8, 10 or 12) in 1:1 allocation ratio for the subjects to receive either the T-FAME-HF or HF education program. Single blinding is maintained by using the another research assistant (RA2), who has no information about group assignment, to collect the post-test self-reported data on outcome variables (i.e. self-care, HRQL and family functioning) via telephone interview.

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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.

Arms & Interventions

The technology-based family-centered empowerment program for heart failure (T-FAME-HF)

Experimental

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 post-discharge disease management, disease monitoring, and patients' access to the nurse, and telephone visits. The Program includes 3 four-week phases, 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. A mobile apps (T-FAME) will be installed in participants' smart-phone and supports the prescribed actions for goal attainment.

Intervention: T-FAME-HF (Other)

Control group - HF education program

Active Comparator

For patients assigned to the control arm will receive 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.

Intervention: Control group - HF education program (Other)