Integrative Management of Patients With Atrial Fibrillation Via Hospital-Community-Family-Based Telemedicine (HCFT-AF) Program

NCT ID: NCT04127799

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-09-30

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.

Conditions

Telemedicine; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Hospital-Community-Family-Care Management Platform Online

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

Group Type: EXPERIMENTAL

Hospital-Community-Family-Care Management Platform Online

Intervention Type: 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.

Subjects with AF conventional treatment

Intervention Type: OTHER

Subjects with standardized treatment according to latest guidelines via conventional visit.

Subjects with AF conventional treatment

Subjects with AF via conventional clinic visit according to the latest relevant guidelines

Group Type: ACTIVE_COMPARATOR

Subjects with AF conventional treatment

Intervention Type: OTHER

Subjects with standardized treatment according to latest guidelines via conventional visit.

Interventions

Hospital-Community-Family-Care Management Platform Online

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.

Intervention Type: OTHER

Subjects with AF conventional treatment

Subjects with standardized treatment according to latest guidelines via conventional visit.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Jiangsu People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiang Gu

Director of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lei Sun, Master

Role: STUDY_DIRECTOR

Department of cardiovascular medicine

Ye Zhu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of cardiovascular medicine

Xiaolin Sun, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of cardiovascular medicine

Jiang Jiang, Master

Role: PRINCIPAL_INVESTIGATOR

Department of cardiovascular medicine

Locations

Department of cardiovascular medicine,Northern Jiangsu Hospital

Yangzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiang Gu, Doctor

Role: CONTACT

sbyygx@medmail.com.cn

+86 0514 87373366

Hongxiao Li, Doctor

Role: CONTACT

lhxlmt@126.com

+86 0514 87373367

Facility Contacts

Hongxiao Li, Doctor

Role: primary

+86 0514 87373367

References

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.

Reference Type: DERIVED

PMID: 33084588 (View on PubMed)

Other Identifiers

BL2019083

Identifier Type: -

Identifier Source: org_study_id