An interventional study of T-FAME-HF and Control group - HF education program in Heart Failure, Telerehabilitation and Self Care, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 270 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
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
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 32th week
Self-Care Heart Failure Index (SCHFI, v.7.2)
Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes.
Time frame: Baseline
Self-Care Heart Failure Index (SCHFI, v.7.2)
Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes.
Time frame: 8th week
Self-Care Heart Failure Index (SCHFI, v.7.2)
Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes.
Time frame: 16th week
Self-Care Heart Failure Index (SCHFI, v.7.2)
Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes.
Time frame: 24th week
Self-Care Heart Failure Index (SCHFI, v.7.2)
Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes.
Time frame: 32th week
Self-Care Self-Efficacy Scale (SCSE)
Evaluate the confidence level of patients with chronic disease on their self-care self-efficacy. There are 10 items and each item is rated from 1 (not confident) to 5 (extremely confident), with higher scores indicating better self-care attributes.
Time frame: Baseline
Self-Care Self-Efficacy Scale (SCSE)
Evaluate the confidence level of patients with chronic disease on their self-care self-efficacy. There are 10 items and each item is rated from 1 (not confident) to 5 (extremely confident), with higher scores indicating better self-care attributes.
Time frame: 8th week
Self-Care Self-Efficacy Scale (SCSE)
Evaluate the confidence level of patients with chronic disease on their self-care self-efficacy. There are 10 items and each item is rated from 1 (not confident) to 5 (extremely confident), with higher scores indicating better self-care attributes.
Time frame: 16th week
Self-Care Self-Efficacy Scale (SCSE)
Evaluate the confidence level of patients with chronic disease on their self-care self-efficacy. There are 10 items and each item is rated from 1 (not confident) to 5 (extremely confident), with higher scores indicating better self-care attributes.
Time frame: 24th week
Self-Care Self-Efficacy Scale (SCSE)
Evaluate the confidence level of patients with chronic disease on their self-care self-efficacy. There are 10 items and each item is rated from 1 (not confident) to 5 (extremely confident), with higher scores indicating better self-care attributes.
Time frame: 32th week
The EuroQoL-5-D instruments
Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems , moderate problems, severe problems and unable to) response set, with "unable to" levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome.
Time frame: Baseline
The EuroQoL-5-D instruments
Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (1 to 5) response set, with higher levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome.
Time frame: 8th week
The EuroQoL-5-D instruments
Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems , moderate problems, severe problems and unable to) response set, with "unable to" levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome.
Time frame: 16th week
The EuroQoL-5-D instruments
Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems , moderate problems, severe problems and unable to) response set, with "unable to" levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome.
Time frame: 24th week
The EuroQoL-5-D instruments
Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems , moderate problems, severe problems and unable to) response set, with "unable to" levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome.
Time frame: 32th week
Family Assessment Device Questionnaire - Global Family Function Subscale
Measure the patients' perception of the overall function of the family in supporting the disease management. Each item is rated from one to four (strongly agree, agree, disagree and strongly disagree), higher scores mean a worse outcome.
Time frame: Baseline
Family Assessment Device Questionnaire - Global Family Function Subscale
Measure the patients' perception of the overall function of the family in supporting the disease management. Each item is rated from one to four (strongly agree, agree, disagree and strongly disagree), higher scores mean a worse outcome.
Time frame: 8th week
Family Assessment Device Questionnaire - Global Family Function Subscale
Measure the patients' perception of the overall function of the family in supporting the disease management. Each item is rated from one to four (strongly agree, agree, disagree and strongly disagree), higher scores mean a worse outcome.
Time frame: 16th week
Family Assessment Device Questionnaire - Global Family Function Subscale
Measure the patients' perception of the overall function of the family in supporting the disease management. Each item is rated from one to four (strongly agree, agree, disagree and strongly disagree), higher scores mean a worse outcome.
Time frame: 24th week
Family Assessment Device Questionnaire - Global Family Function Subscale
Measure the patients' perception of the overall function of the family in supporting the disease management. Each item is rated from one to four (strongly agree, agree, disagree and strongly disagree), higher scores mean a worse outcome.
Time frame: 32th week
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Only study investigators and research assistants involved in the study will have access to the data.
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