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| Name | Class |
|---|---|
| Hospital Authority, Hong Kong | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris Sau Fung YU, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, PoK Oi Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15860828 | Result | 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. | |
| 23747642 | Result | 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. |
| Label | URL |
|---|---|
| Hospital Authority. Hospital Authority Statistical Report 2011/ 2012. Hong Kong: Hong Kong Hospital Authority; 2013. | View source |
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Only study investigators and research assistants involved in the study will have access to the data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2021 | Jun 29, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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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.
| 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 32th week |
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