Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT04991857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2021-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Technology-based Family-centered Empowerment Program for Heart Failure (T-FAME-HF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000079102', 'term': 'Empowerment'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-15', 'size': 521302, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-29T05:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minnesota Living with Heart Failure (MLHF) questionnaire', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Minnesota Living with Heart Failure (MLHF) questionnaire', 'timeFrame': '8th week', 'description': '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.'}, {'measure': 'Minnesota Living with Heart Failure (MLHF) questionnaire', 'timeFrame': '16th week', 'description': '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.'}, {'measure': 'Minnesota Living with Heart Failure (MLHF) questionnaire', 'timeFrame': '24th week', 'description': '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.'}, {'measure': 'Minnesota Living with Heart Failure (MLHF) questionnaire', 'timeFrame': '32th week', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Self-Care Heart Failure Index (SCHFI, v.7.2)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Self-Care Heart Failure Index (SCHFI, v.7.2)', 'timeFrame': '8th week', 'description': '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.'}, {'measure': 'Self-Care Heart Failure Index (SCHFI, v.7.2)', 'timeFrame': '16th week', 'description': '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.'}, {'measure': 'Self-Care Heart Failure Index (SCHFI, v.7.2)', 'timeFrame': '24th week', 'description': '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.'}, {'measure': 'Self-Care Heart Failure Index (SCHFI, v.7.2)', 'timeFrame': '32th week', 'description': '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.'}, {'measure': 'Self-Care Self-Efficacy Scale (SCSE)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Self-Care Self-Efficacy Scale (SCSE)', 'timeFrame': '8th week', 'description': '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.'}, {'measure': 'Self-Care Self-Efficacy Scale (SCSE)', 'timeFrame': '16th week', 'description': '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.'}, {'measure': 'Self-Care Self-Efficacy Scale (SCSE)', 'timeFrame': '24th week', 'description': '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.'}, {'measure': 'Self-Care Self-Efficacy Scale (SCSE)', 'timeFrame': '32th week', 'description': '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.'}, {'measure': 'The EuroQoL-5-D instruments', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'The EuroQoL-5-D instruments', 'timeFrame': '8th week', 'description': '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.'}, {'measure': 'The EuroQoL-5-D instruments', 'timeFrame': '16th week', 'description': '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.'}, {'measure': 'The EuroQoL-5-D instruments', 'timeFrame': '24th week', 'description': '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.'}, {'measure': 'The EuroQoL-5-D instruments', 'timeFrame': '32th week', 'description': '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.'}, {'measure': 'Family Assessment Device Questionnaire - Global Family Function Subscale', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Family Assessment Device Questionnaire - Global Family Function Subscale', 'timeFrame': '8th week', 'description': "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."}, {'measure': 'Family Assessment Device Questionnaire - Global Family Function Subscale', 'timeFrame': '16th week', 'description': "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."}, {'measure': 'Family Assessment Device Questionnaire - Global Family Function Subscale', 'timeFrame': '24th week', 'description': "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."}, {'measure': 'Family Assessment Device Questionnaire - Global Family Function Subscale', 'timeFrame': '32th week', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Telerehabilitation', 'Self Care', 'Empowerment', 'Disease Management'], 'conditions': ['Heart Failure', 'Telerehabilitation', 'Self Care', 'Empowerment', 'Disease Management']}, 'referencesModule': {'references': [{'pmid': '15860828', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23747642', 'type': 'RESULT', 'citation': 'Yancy 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.'}, {'pmid': '12657079', 'type': 'RESULT', 'citation': 'Coleman 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.'}, {'pmid': '26553896', 'type': 'RESULT', 'citation': 'Vedel 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.'}, {'pmid': '29397988', 'type': 'RESULT', 'citation': 'Stamp 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.'}, {'pmid': '23018072', 'type': 'RESULT', 'citation': 'Griffiths 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.'}, {'pmid': '32215957', 'type': 'RESULT', 'citation': 'Smith 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.'}, {'pmid': '26751971', 'type': 'RESULT', 'citation': 'Deek 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.'}, {'pmid': '29567335', 'type': 'RESULT', 'citation': 'Ostergaard 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.'}, {'pmid': '8319323', 'type': 'RESULT', 'citation': 'Ho 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.'}, {'pmid': '26289684', 'type': 'RESULT', 'citation': 'Yu 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.'}, {'pmid': '30303894', 'type': 'RESULT', 'citation': 'Riegel 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.'}, {'pmid': '33295675', 'type': 'RESULT', 'citation': 'Yu 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.'}, {'pmid': '19786884', 'type': 'RESULT', 'citation': 'Riegel 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.'}, {'pmid': '31350765', 'type': 'RESULT', 'citation': 'Yu 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.'}, {'pmid': '18004191', 'type': 'RESULT', 'citation': 'Ho CC, Clochesy JM, Madigan E, Liu CC. Psychometric evaluation of the Chinese version of the Minnesota Living with Heart Failure Questionnaire. Nurs Res. 2007 Nov-Dec;56(6):441-8. doi: 10.1097/01.NNR.0000299849.21935.c4.'}, {'pmid': '29572719', 'type': 'RESULT', 'citation': 'Buchholz I, Janssen MF, Kohlmann T, Feng YS. A Systematic Review of Studies Comparing the Measurement Properties of the Three-Level and Five-Level Versions of the EQ-5D. Pharmacoeconomics. 2018 Jun;36(6):645-661. doi: 10.1007/s40273-018-0642-5.'}, {'pmid': '27525314', 'type': 'RESULT', 'citation': 'Cheung PWH, Wong CKH, Samartzis D, Luk KDK, Lam CLK, Cheung KMC, Cheung JPY. Psychometric validation of the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in Chinese patients with adolescent idiopathic scoliosis. Scoliosis Spinal Disord. 2016 Aug 4;11:19. doi: 10.1186/s13013-016-0083-x. eCollection 2016.'}, {'pmid': '25673525', 'type': 'RESULT', 'citation': 'Stamp KD, Dunbar SB, Clark PC, Reilly CM, Gary RA, Higgins M, Ryan RM. Family partner intervention influences self-care confidence and treatment self-regulation in patients with heart failure. Eur J Cardiovasc Nurs. 2016 Aug;15(5):317-27. doi: 10.1177/1474515115572047. Epub 2015 Feb 11.'}, {'pmid': '32472800', 'type': 'RESULT', 'citation': 'Chen S, Zheng S, Wang X, Zhang X, Fa T, Fu L, Zang X, Zhao Y. Linguistic and Psychometric Validation of the Chinese Version of the Control Attitudes Scale-Revised in Patients With Chronic Heart Failure. J Cardiovasc Nurs. 2021 Jul-Aug 01;36(4):349-356. doi: 10.1097/JCN.0000000000000705.'}, {'pmid': '15033648', 'type': 'RESULT', 'citation': 'Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090.'}, {'pmid': '25128053', 'type': 'RESULT', 'citation': 'Liu GG, Wu H, Li M, Gao C, Luo N. Chinese time trade-off values for EQ-5D health states. Value Health. 2014 Jul;17(5):597-604. doi: 10.1016/j.jval.2014.05.007. Epub 2014 Jul 23.'}, {'pmid': '10784550', 'type': 'RESULT', 'citation': 'Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ. 2000 Apr 29;320(7243):1197-200. doi: 10.1136/bmj.320.7243.1197. No abstract available.'}, {'pmid': '15127421', 'type': 'RESULT', 'citation': "Fenwick E, O'Brien BJ, Briggs A. Cost-effectiveness acceptability curves--facts, fallacies and frequently asked questions. Health Econ. 2004 May;13(5):405-15. doi: 10.1002/hec.903."}], 'seeAlsoLinks': [{'url': 'https://www3.ha.org.hk/data/HAStatistics/DownloadReport/6?isPreview=False', 'label': 'Hospital Authority. Hospital Authority Statistical Report 2011/ 2012. Hong Kong: Hong Kong Hospital Authority; 2013.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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.\n\nFor 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT04991857', 'acronym': 'T-FAME-HF', 'briefTitle': 'Technology-based Family-centered Empowerment Program for Heart Failure (T-FAME-HF)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'T-FAME-HF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The technology-based family-centered empowerment program for heart failure (T-FAME-HF)', 'description': "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.", 'interventionNames': ['Other: T-FAME-HF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group - HF education program', 'description': '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.', 'interventionNames': ['Other: Control group - HF education program']}], 'interventions': [{'name': 'T-FAME-HF', 'type': 'OTHER', 'description': "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", 'armGroupLabels': ['The technology-based family-centered empowerment program for heart failure (T-FAME-HF)']}, {'name': 'Control group - HF education program', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control group - HF education program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Medicine, PoK Oi Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Doris Sau Fung YU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only study investigators and research assistants involved in the study will have access to the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Yu, Doris Sau Fung', 'investigatorAffiliation': 'The University of Hong Kong'}}}}