Integrative Management of Patients With Atrial Fibrillation Via Hospital-Community-Family-Based Telemedicine (HCFT-AF) Program
Northern Jiangsu Province People's Hospital
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJune 16, 2020
February 1, 2020
3.2 years
September 30, 2019
June 11, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
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
Secondary Outcomes (8)
Incidence of systemic embolism
2 year
Incidence of transient ischemic attack
2 year
Incidence of severe hemorrhage
2 year
Incidence of slight hemorrhage
2 year
Usability of the AF telemedicine platform intervention for patients
4 months
- +3 more secondary outcomes
Study Arms (2)
Hospital-Community-Family-Care Management Platform Online
EXPERIMENTALHospital-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 COMPARATORSubjects with AF via conventional clinic visit according to the latest relevant guidelines
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old;
- Meeting the diagnostic criteria for atrial fibrillation;
- Subjects can understand the situation of this study and agree to sign informed consent and continue to follow up.
You may not qualify if:
- 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;
- There is no recurrence of atrial fibrillation after surgical treatment;
- Due to other serious diseases, the expected survival time is less than 1 year;
- Severe liver and kidney disease: serum creatinine\>5.0mg/dl; ALT exceeds the reference value by more than 3 times (ALT\> 100u/L);
- Systolic or diastolic blood pressure ≥ 180/110mm Hg (1mm Hg = 0.133kPa), but can be selected after blood pressure control;
- Diagnosed or suspected blood system diseases (except for mild to moderate anemia) leading to coagulopathy or accompanied by bleeding tendency;
- Pregnant and lactating women;
- Reluctance to use remote monitoring equipment (such as depression, dementia, impaired autonomy, lack of communication skills);
- Participating in other treatment research or remote patient management programs;
- The investigator consider that it is not suitable for joining the study;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of cardiovascular medicine,Northern Jiangsu Hospital
Yangzhou, Jiangsu, 225001, China
Related Publications (1)
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.
PMID: 33084588DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lei Sun, Master
Department of cardiovascular medicine
- PRINCIPAL INVESTIGATOR
Ye Zhu, Doctor
Department of cardiovascular medicine
- PRINCIPAL INVESTIGATOR
Xiaolin Sun, Doctor
Department of cardiovascular medicine
- PRINCIPAL INVESTIGATOR
Jiang Jiang, Master
Department of cardiovascular medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of cardiology
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 16, 2019
Study Start
November 1, 2019
Primary Completion
December 30, 2022
Study Completion
September 30, 2023
Last Updated
June 16, 2020
Record last verified: 2020-02