Technology-based Family-centered Empowerment Program for Heart Failure (T-FAME-HF)

NCT04991857 | Completed DMC

• 1 other identifier: T-FAME-HF
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Telerehabilitation; Self Care; Empowerment; Disease Management

Keywords

Heart Failure; Telerehabilitation; Self Care; Empowerment; Disease Management

Outcome Measures

Primary Outcomes (5)

• Minnesota Living with Heart Failure (MLHF) questionnaire

  Measure the disease-specific health-related quality of life (HRQL). There are 21 items and each item is rated from 0 to 5, with higher scores indicating worse outcome.

  Baseline

• Minnesota Living with Heart Failure (MLHF) questionnaire

  Measure the disease-specific health-related quality of life (HRQL). There are 21 items and each item is rated from 0 to 5, with higher scores indicating worse outcome.

  8th week

• Minnesota Living with Heart Failure (MLHF) questionnaire

  Measure the disease-specific health-related quality of life (HRQL). There are 21 items and each item is rated from 0 to 5, with higher scores indicating worse outcome.

  16th week

• Minnesota Living with Heart Failure (MLHF) questionnaire

  Measure the disease-specific health-related quality of life (HRQL). There are 21 items and each item is rated from 0 to 5, with higher scores indicating worse outcome.

  24th week

• Minnesota Living with Heart Failure (MLHF) questionnaire

  Measure the disease-specific health-related quality of life (HRQL). There are 21 items and each item is rated from 0 to 5, with higher scores indicating worse outcome.

  32th week

Secondary Outcomes (20)

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  Baseline

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  8th week

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  16th week

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  24th week

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  32th week

Study Arms (2)

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.

Other: T-FAME-HF

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.

Other: Control group - HF education program

Interventions

T-FAME-HF OTHER

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

Control group - HF education program OTHER

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 the team nurse, five bi-weekly online training on self-care through videos on Whatapps/ WeChat with two subsequent telephone follow-up.

Control group - HF education program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Authority, Hong Kong: collaborator
• The University of Hong Kong: lead

Study Sites (1)

Department of Medicine, PoK Oi Hospital

Hong Kong, Hong Kong

Location

Related Publications (24)

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Related Links

• Hospital Authority. Hospital Authority Statistical Report 2011/ 2012. Hong Kong: Hong Kong Hospital Authority; 2013.

MeSH Terms

Conditions

Heart Failure; Empowerment

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Officials

• Doris Sau Fung YU, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: September 19, 2021
• Primary Completion: August 30, 2025
• Study Completion: February 28, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)