Heart FailureT-FAME-HFNCT04991857
Technology-based Family-centered Empowerment Program for Heart Failure (T-FAME-HF)
A study testing T-FAME-HF in people with Heart Failure and Telerehabilitation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Telerehabilitation, Self Care
- What is being tested?
- T-FAME-HF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Sep 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Telerehabilitation, Self Care, Empowerment, Disease Management
- Being tested
- T-FAME-HF, Control group - HF education program
- Keywords
- Heart Failure, Telerehabilitation, Self Care, Empowerment, Disease Management
- Medical subject headings
- Heart Failure, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-FAME-HFOther
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
Control group - HF education programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group - HF education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 32th week
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 32th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start19 Sep 2021
- Primary completion30 Aug 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Prof. Yu, Doris Sau Fung, The University of Hong Kong
- Investigators
- Doris Sau Fung YU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991857
- Sponsor's protocol ID
- T-FAME-HF
- Acronym
- T-FAME-HF
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only study investigators and research assistants involved in the study will have access to the data.
Publications
Murray SA, Kendall M, Boyd K, Sheikh A. Illness trajectories and palliative care. BMJ. 2005 Apr 30;330(7498):1007-11. doi: 10.1136/bmj.330.7498.1007. No abstract available.
PubMed 15860828Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
PubMed 23747642Coleman EA, Boult C; American Geriatrics Society Health Care Systems Committee. Improving the quality of transitional care for persons with complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):556-7. doi: 10.1046/j.1532-5415.2003.51186.x. No abstract available.
PubMed 12657079Vedel I, Khanassov V. Transitional Care for Patients With Congestive Heart Failure: A Systematic Review and Meta-Analysis. Ann Fam Med. 2015 Nov;13(6):562-71. doi: 10.1370/afm.1844.
PubMed 26553896Stamp KD, Prasun M, Lee CS, Jaarsma T, Piano MR, Albert NM. Nursing research in heart failure care: a position statement of the american association of heart failure nurses (AAHFN). Heart Lung. 2018 Mar-Apr;47(2):169-175. doi: 10.1016/j.hrtlng.2018.01.003. Epub 2018 Feb 15.
PubMed 29397988Griffiths SM, Lee JP. Developing primary care in Hong Kong: evidence into practice and the development of reference frameworks. Hong Kong Med J. 2012 Oct;18(5):429-34.
PubMed 23018072Smith J, Ali P, Birks Y, Curtis P, Fairbrother H, Kirk S, Saltiel D, Thompson J, Swallow V. Umbrella review of family-focused care interventions supporting families where a family member has a long-term condition. J Adv Nurs. 2020 Aug;76(8):1911-1923. doi: 10.1111/jan.14367. Epub 2020 Apr 15.
PubMed 32215957Deek H, Hamilton S, Brown N, Inglis SC, Digiacomo M, Newton PJ, Noureddine S, MacDonald PS, Davidson PM; FAMILY Project Investigators. Family-centred approaches to healthcare interventions in chronic diseases in adults: a quantitative systematic review. J Adv Nurs. 2016 May;72(5):968-79. doi: 10.1111/jan.12885. Epub 2016 Jan 10.
PubMed 26751971Ostergaard B, Mahrer-Imhof R, Wagner L, Barington T, Videbaek L, Lauridsen J. Effect of family nursing therapeutic conversations on health-related quality of life, self-care and depression among outpatients with heart failure: A randomized multi-centre trial. Patient Educ Couns. 2018 Aug;101(8):1385-1393. doi: 10.1016/j.pec.2018.03.006. Epub 2018 Mar 7.
PubMed 29567335Ho KK, Anderson KM, Kannel WB, Grossman W, Levy D. Survival after the onset of congestive heart failure in Framingham Heart Study subjects. Circulation. 1993 Jul;88(1):107-15. doi: 10.1161/01.cir.88.1.107.
PubMed 8319323Yu DS, Lee DT, Stewart S, Thompson DR, Choi KC, Yu CM. Effect of Nurse-Implemented Transitional Care for Chinese Individuals with Chronic Heart Failure in Hong Kong: A Randomized Controlled Trial. J Am Geriatr Soc. 2015 Aug;63(8):1583-93. doi: 10.1111/jgs.13533.
PubMed 26289684Riegel B, Barbaranelli C, Carlson B, Sethares KA, Daus M, Moser DK, Miller J, Osokpo OH, Lee S, Brown S, Vellone E. Psychometric Testing of the Revised Self-Care of Heart Failure Index. J Cardiovasc Nurs. 2019 Mar/Apr;34(2):183-192. doi: 10.1097/JCN.0000000000000543.
PubMed 30303894Yu DS, De Maria M, Barbaranelli C, Vellone E, Matarese M, Ausili D, Rejane RE, Osokpo OH, Riegel B. Cross-cultural applicability of the Self-Care Self-Efficacy Scale in a multi-national study. J Adv Nurs. 2021 Feb;77(2):681-692. doi: 10.1111/jan.14617. Epub 2020 Dec 9.
PubMed 33295675Riegel B, Lee CS, Dickson VV, Carlson B. An update on the self-care of heart failure index. J Cardiovasc Nurs. 2009 Nov-Dec;24(6):485-97. doi: 10.1097/JCN.0b013e3181b4baa0.
PubMed 19786884Yu DSF, Li PWC, Yue SCS, Wong J, Yan B, Tsang KK, Choi KC. The effects and cost-effectiveness of an empowerment-based self-care programme in patients with chronic heart failure: A study protocol. J Adv Nurs. 2019 Dec;75(12):3740-3748. doi: 10.1111/jan.14162. Epub 2019 Aug 27.
PubMed 31350765
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04991857
- Acronym / sponsor ID
- T-FAME-HF / T-FAME-HF
- Conditions
- Heart Failure, Telerehabilitation, Self Care, Empowerment, Disease Management
- Keywords
- Heart Failure, Telerehabilitation, Self Care, Empowerment, Disease Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- 19 Sep 2021 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The technology-based family-centered empowerment program for heart failure (T-FAME-HF) | Experimental | Other: T-FAME-HFThe 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. |
| Control group - HF education program | Active comparator | Other: Control group - HF education programFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-FAME-HF16-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 | Other | The technology-based family-centered empowerment program for heart failure (T-FAME-HF) |
| Control group - HF education programFor 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. | Other | Control group - HF education program |
Primary outcome
Minnesota Living with Heart Failure (MLHF) questionnaire
Time frame: Baseline
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.
Minnesota Living with Heart Failure (MLHF) questionnaire
Time frame: 8th week
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.
Minnesota Living with Heart Failure (MLHF) questionnaire
Time frame: 16th week
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.
Minnesota Living with Heart Failure (MLHF) questionnaire
Time frame: 24th week
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.
Minnesota Living with Heart Failure (MLHF) questionnaire
Time frame: 32th week
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.
20 secondary outcomes
Self-Care Heart Failure Index (SCHFI, v.7.2)
Time frame: Baseline
Self-Care Heart Failure Index (SCHFI, v.7.2)
Time frame: 8th week
Self-Care Heart Failure Index (SCHFI, v.7.2)
Time frame: 16th week
Self-Care Heart Failure Index (SCHFI, v.7.2)
Time frame: 24th week
Self-Care Heart Failure Index (SCHFI, v.7.2)
Time frame: 32th week
Self-Care Self-Efficacy Scale (SCSE)
Time frame: Baseline
Self-Care Self-Efficacy Scale (SCSE)
Time frame: 8th week
Self-Care Self-Efficacy Scale (SCSE)
Time frame: 16th week
Self-Care Self-Efficacy Scale (SCSE)
Time frame: 24th week
Self-Care Self-Efficacy Scale (SCSE)
Time frame: 32th week
The EuroQoL-5-D instruments
Time frame: Baseline
The EuroQoL-5-D instruments
Time frame: 8th week
The EuroQoL-5-D instruments
Time frame: 16th week
The EuroQoL-5-D instruments
Time frame: 24th week
The EuroQoL-5-D instruments
Time frame: 32th week
Family Assessment Device Questionnaire - Global Family Function Subscale
Time frame: Baseline
Family Assessment Device Questionnaire - Global Family Function Subscale
Time frame: 8th week
Family Assessment Device Questionnaire - Global Family Function Subscale
Time frame: 16th week
Family Assessment Device Questionnaire - Global Family Function Subscale
Time frame: 24th week
Family Assessment Device Questionnaire - Global Family Function Subscale
Time frame: 32th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 15860828Murray SA, Kendall M, Boyd K, Sheikh A. Illness trajectories and palliative care. BMJ. 2005 Apr 30;330(7498):1007-11. doi: 10.1136/bmj.330.7498.1007. No abstract available.
- Results publication: PubMed 23747642Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
- Results publication: PubMed 12657079Coleman EA, Boult C; American Geriatrics Society Health Care Systems Committee. Improving the quality of transitional care for persons with complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):556-7. doi: 10.1046/j.1532-5415.2003.51186.x. No abstract available.
- Results publication: PubMed 26553896Vedel I, Khanassov V. Transitional Care for Patients With Congestive Heart Failure: A Systematic Review and Meta-Analysis. Ann Fam Med. 2015 Nov;13(6):562-71. doi: 10.1370/afm.1844.
- Results publication: PubMed 29397988Stamp KD, Prasun M, Lee CS, Jaarsma T, Piano MR, Albert NM. Nursing research in heart failure care: a position statement of the american association of heart failure nurses (AAHFN). Heart Lung. 2018 Mar-Apr;47(2):169-175. doi: 10.1016/j.hrtlng.2018.01.003. Epub 2018 Feb 15.
- Results publication: PubMed 23018072Griffiths SM, Lee JP. Developing primary care in Hong Kong: evidence into practice and the development of reference frameworks. Hong Kong Med J. 2012 Oct;18(5):429-34.
- Results publication: PubMed 32215957Smith J, Ali P, Birks Y, Curtis P, Fairbrother H, Kirk S, Saltiel D, Thompson J, Swallow V. Umbrella review of family-focused care interventions supporting families where a family member has a long-term condition. J Adv Nurs. 2020 Aug;76(8):1911-1923. doi: 10.1111/jan.14367. Epub 2020 Apr 15.
- Results publication: PubMed 26751971Deek H, Hamilton S, Brown N, Inglis SC, Digiacomo M, Newton PJ, Noureddine S, MacDonald PS, Davidson PM; FAMILY Project Investigators. Family-centred approaches to healthcare interventions in chronic diseases in adults: a quantitative systematic review. J Adv Nurs. 2016 May;72(5):968-79. doi: 10.1111/jan.12885. Epub 2016 Jan 10.
- Results publication: PubMed 29567335Ostergaard B, Mahrer-Imhof R, Wagner L, Barington T, Videbaek L, Lauridsen J. Effect of family nursing therapeutic conversations on health-related quality of life, self-care and depression among outpatients with heart failure: A randomized multi-centre trial. Patient Educ Couns. 2018 Aug;101(8):1385-1393. doi: 10.1016/j.pec.2018.03.006. Epub 2018 Mar 7.
- Results publication: PubMed 8319323Ho KK, Anderson KM, Kannel WB, Grossman W, Levy D. Survival after the onset of congestive heart failure in Framingham Heart Study subjects. Circulation. 1993 Jul;88(1):107-15. doi: 10.1161/01.cir.88.1.107.
- Results publication: PubMed 26289684Yu DS, Lee DT, Stewart S, Thompson DR, Choi KC, Yu CM. Effect of Nurse-Implemented Transitional Care for Chinese Individuals with Chronic Heart Failure in Hong Kong: A Randomized Controlled Trial. J Am Geriatr Soc. 2015 Aug;63(8):1583-93. doi: 10.1111/jgs.13533.
- Results publication: PubMed 30303894Riegel B, Barbaranelli C, Carlson B, Sethares KA, Daus M, Moser DK, Miller J, Osokpo OH, Lee S, Brown S, Vellone E. Psychometric Testing of the Revised Self-Care of Heart Failure Index. J Cardiovasc Nurs. 2019 Mar/Apr;34(2):183-192. doi: 10.1097/JCN.0000000000000543.
- Hospital Authority. Hospital Authority Statistical Report 2011/ 2012. Hong Kong: Hong Kong Hospital Authority; 2013.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Only study investigators and research assistants involved in the study will have access to the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Sau Fung YU, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-FAME-HF in people with Heart Failure and Telerehabilitation, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minnesota Living with Heart Failure (MLHF) questionnaire (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991857, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.