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Atrial fibrillation (AF) is one of the most common arrhythmias. Its repeated fluctuations in ventricular rate and irregular heart rhythm not only reduce exercise tolerance and quality of life, but also cause hemodynamic changes. The incidence of stroke is increased by 5 times or more compared with the average person. According to statistics, the annual mortality rate from stroke due to atrial fibrillation is about 20%-25%. Of course, like other cardiovascular diseases, atrial fibrillation occurs in a large proportion of the elderly population. According to statistics, 80% of patients with atrial fibrillation are 65 years of age or older. With the aging of the world's population, especially in the 21st century, the proportion of patients with atrial fibrillation has increased year by year. The treatment of atrial fibrillation involves many aspects such as switching to sinus rhythm, controlling heart rate and anticoagulant therapy, which is a long course affecting the adherence of AF patients. AF is a kind of disease that can be preventable and controllable. The out-of-hospital care for AF patients has been proved to reduce the mortality and unexpected readmission rate, but there are still high costs, poor compliance, low management efficiency and etc. Telemedicine was believed to solve these problems to further reduce the mortality of AF patients. The latest ESC Heart Failure Guidelines emphasis the significance of telemedicine in AF, however, it didn't provide a standardized AF remote management system.
Subjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up. In the program, participants were educated on the use of smart health-tracking devices and mobile application (APP) to collect and upload comprehensive data elements related to the risk of AF self-care management. They were also instructed to send text messages, view notifications, and receive individualized guidance on the mobile APP. The general practitioners viewed index of each participant on mobile APP and provided primary care periodically, and cardiologists in regional central hospital offered remote guidance and management if necessary. Outcomes assessed included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of AF-related health behaviors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital-Community-Family-Care Management Platform Online | Experimental | Hospital-Community-Family-Care Management Platform Online: the remote monitoring service platform on line based on community and family for subjects with CHF under the guidance of the regional central hospital |
|
| Subjects with AF conventional treatment | Active Comparator | Subjects with AF via conventional clinic visit according to the latest relevant guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital-Community-Family-Care Management Platform Online | Other | Subjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up. In the program, participants were educated on the use of smart health-tracking devices and mobile application (APP) to collect and upload comprehensive data elements related to the risk of AF self-care management. They were also instructed to send text messages, view notifications, and receive individualized guidance on the mobile APP. The general practitioners viewed index of each participant on mobile APP and provided primary care periodically, and cardiologists in regional central hospital offered remote guidance and management if necessary. Outcomes assessed included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of AF-related health behaviors. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of ischemic stroke | 1 year | |
| The incidence of ischemic stroke | 2 year | |
| Cardiovascular mortality | 1 year | |
| Cardiovascular mortality | 2 year | |
| all-cause mortality | 1 year | |
| all-cause mortality | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of systemic embolism | Systemic embolism (Limb, kidney, mesenteric artery, lung, retina, etc. must be confirmed by vascular ultrasound, angiography, surgery or biopsy) | 2 year |
| Incidence of transient ischemic attack |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Gu, Doctor | Contact | +86 0514 87373366 | sbyygx@medmail.com.cn | |
| Hongxiao Li, Doctor | Contact | +86 0514 87373367 | lhxlmt@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Sun, Master | Department of cardiovascular medicine | Study Director |
| Ye Zhu, Doctor | Department of cardiovascular medicine | Principal Investigator |
| Xiaolin Sun, Doctor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of cardiovascular medicine,Northern Jiangsu Hospital | Recruiting | Yangzhou | Jiangsu | 225001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33084588 | Derived | Jiang J, Gu X, Cheng CD, Li HX, Sun XL, Duan RY, Zhu Y, Sun L, Chen FK, Bao ZY, Zhang Y, Shen JH. The Hospital-Community-Family-Based Telemedicine (HCFT-AF) Program for Integrative Management of Patients With Atrial Fibrillation: Pilot Feasibility Study. JMIR Mhealth Uhealth. 2020 Oct 21;8(10):e22137. doi: 10.2196/22137. |
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|
| Subjects with AF conventional treatment | Other | Subjects with standardized treatment according to latest guidelines via conventional visit. |
|
| 2 year |
| Incidence of severe hemorrhage | Fatal, life-threatening or potentially fatal bleeding requiring blood transfusion or surgical intervention | 2 year |
| Incidence of slight hemorrhage | Obvious or recessive gastrointestinal bleeding, hemoptysis, nosebleeds, gross hematuria, subcutaneous congestion, anemia caused by blood loss, moderate chronic blood loss | 2 year |
| Usability of the AF telemedicine platform intervention for patients | Perceived Health Web Site Usability Questionnaire (PHWSUQ)[1]
| 4 months |
| Changes of lifestyles and healthy behaviors | Patients lifestyles and behaviors, associated with the occurrence and progress of AF, were collected at baseline, and 4 months through interviews, with the purpose of evaluating changes in self-management of patients. | 4 months |
| Drug adherence | Patients drug adherence was assessed via the Pharmacy Quality Alliance adherence measure at baseline and 4 months individually. Pharmacy Quality Alliance adherence measure
Note: Add up the total number of points from the checked boxes Score Interpretation 0: Low risk for adherence problems (>75% probability of adherence) 2-7: Medium risk for adherence problems (32-75% probability of adherence) 8+ High risk for adherence problems (<32% probability of adherence) | 4 months |
| Engagement of the intervention | It was assessed objectively via daily Web portal log-ins and use of the mobile APP | 4 months |
| Department of cardiovascular medicine |
| Principal Investigator |
| Jiang Jiang, Master | Department of cardiovascular medicine | Principal Investigator |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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