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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
1,000
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.
Subjects with standardized treatment according to latest guidelines via conventional visit.
Department of cardiovascular medicine,Northern Jiangsu Hospital
Yangzhou, Jiangsu, China
RECRUITINGThe incidence of ischemic stroke
Time frame: 1 year
The incidence of ischemic stroke
Time frame: 2 year
Cardiovascular mortality
Time frame: 1 year
Cardiovascular mortality
Time frame: 2 year
all-cause mortality
Time frame: 1 year
all-cause mortality
Time frame: 2 year
Incidence of systemic embolism
Systemic embolism (Limb, kidney, mesenteric artery, lung, retina, etc. must be confirmed by vascular ultrasound, angiography, surgery or biopsy)
Time frame: 2 year
Incidence of transient ischemic attack
Time frame: 2 year
Incidence of severe hemorrhage
Fatal, life-threatening or potentially fatal bleeding requiring blood transfusion or surgical intervention
Time frame: 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
Time frame: 2 year
Usability of the AF telemedicine platform intervention for patients
Perceived Health Web Site Usability Questionnaire (PHWSUQ)\[1\] 1. Ease of finding specific information 2. Ease of reading the information given 3. Ease of listening to audio-information 4. Overall appearance of the site 5. Overall quality of graphics 6. Quality of video information Ease-of-Use 7. I found the use of this Web site easy to learn. 8. Finding information on this Web site requires a lot of mental effort. 9. Overall, I find this Web site is easy to use. Usefulness 10. Using this Web site will help me understand specific health problem(s). 11. Using this Web site will help me improve my knowledge about health. 12. Using this Web site will help me maintain better health habits. Strongly disagree 1 2 3 4 5 6 7 Strongly agree For each independent assignment, a higher score means a better outcome.
Time frame: 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.
Time frame: 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 1. I am convinced of the importance of my prescription medication 2. I worry that my prescription medication will do more harm than good to me 3. I feel financially burdened by my out-of-pocket expenses for my prescription medication Agree completely/ Agree mostly/ Agree somewhat/Disagree somewhat/ Disagree mostly/Disagree completely 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)
Time frame: 4 months
Engagement of the intervention
It was assessed objectively via daily Web portal log-ins and use of the mobile APP
Time frame: 4 months
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