Clinical trial NCT04127799: Integrative Management of Patients With Atrial Fibrillation Via Hospital-Community-Family-Based Telemedicine (HCFT-AF) Program
Official title: Northern Jiangsu Province People's Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Telemedicine
Atrial Fibrillation
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. Meeting the diagnostic criteria for atrial fibrillation;
3. Subjects can understand the situation of this study and agree to sign informed consent and continue to follow up.

Exclusion Criteria:

1. Atrial fibrillation caused by reversible causes, including: acute myocardial infarction (MI) within 1 month, acute myocarditis within 1 month, untreated hyperthyroidism, and electrophysiological examination, angiography, atrial fibrillation did not reappear after treatment;
2. There is no recurrence of atrial fibrillation after surgical treatment;
3. Due to other serious diseases, the expected survival time is less than 1 year;
4. Severe liver and kidney disease: serum creatinine\>5.0mg/dl; ALT exceeds the reference value by more than 3 times (ALT\> 100u/L);
5. Systolic or diastolic blood pressure ≥ 180/110mm Hg (1mm Hg = 0.133kPa), but can be selected after blood pressure control;
6. Diagnosed or suspected blood system diseases (except for mild to moderate anemia) leading to coagulopathy or accompanied by bleeding tendency;
7. Pregnant and lactating women;
8. Reluctance to use remote monitoring equipment (such as depression, dementia, impaired autonomy, lack of communication skills);
9. Participating in other treatment research or remote patient management programs;
10. The investigator consider that it is not suitable for joining the study;

Primary outcomes:
measure: The incidence of ischemic stroke
timeFrame: 1 year
measure: The incidence of ischemic stroke
timeFrame: 2 year
measure: Cardiovascular mortality
timeFrame: 1 year
measure: Cardiovascular mortality
timeFrame: 2 year
measure: all-cause mortality
timeFrame: 1 year
measure: all-cause mortality
timeFrame: 2 year
Secondary outcomes:
measure: Incidence of systemic embolism
timeFrame: 2 year
measure: Incidence of transient ischemic attack
timeFrame: 2 year
measure: Incidence of severe hemorrhage
timeFrame: 2 year
measure: Incidence of slight hemorrhage
timeFrame: 2 year
measure: Usability of the AF telemedicine platform intervention for patients
timeFrame: 4 months
measure: Changes of lifestyles and healthy behaviors
timeFrame: 4 months
measure: Drug adherence
timeFrame: 4 months
measure: Engagement of the intervention
timeFrame: 4 months
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Department of cardiovascular medicine,Northern Jiangsu Hospital
state: Jiangsu
Study officials:
affiliation: Department of cardiovascular medicine
name: Lei Sun, Master
role: STUDY_DIRECTOR
affiliation: Department of cardiovascular medicine
name: Ye Zhu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of cardiovascular medicine
name: Xiaolin Sun, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of cardiovascular medicine
name: Jiang Jiang, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.