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Hospital-Community-Family-Care Management Platform for Atrial Fibrillation (HCF-CMP-AF)

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ClinicalTrials.gov Identifier: NCT04127799
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xiang Gu, Northern Jiangsu Province People's Hospital

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.

Condition or disease Intervention/treatment Phase
Telemedicine Atrial Fibrillation Other: Hospital-Community-Family-Care Management Platform Online Other: Subjects with AF conventional treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Northern Jiangsu Province People's Hospital
Estimated Study Start Date : November 10, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Other: 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.

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

Active Comparator: Subjects with AF conventional treatment
Subjects with AF via conventional clinic visit according to the latest relevant guidelines
Other: Subjects with AF conventional treatment
Subjects with standardized treatment according to latest guidelines via conventional visit.




Primary Outcome Measures :
  1. The incidence of ischemic stroke [ Time Frame: 1 year ]
  2. The incidence of ischemic stroke [ Time Frame: 2 year ]
  3. Cardiovascular mortality [ Time Frame: 1 year ]
  4. Cardiovascular mortality [ Time Frame: 2 year ]
  5. all-cause mortality [ Time Frame: 1 year ]
  6. all-cause mortality [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Incidence of systemic embolism [ Time Frame: 2 year ]
    Systemic embolism (Limb, kidney, mesenteric artery, lung, retina, etc. must be confirmed by vascular ultrasound, angiography, surgery or biopsy)

  2. Incidence of transient ischemic attack [ Time Frame: 2 year ]
  3. Incidence of severe hemorrhage [ Time Frame: 2 year ]
    Fatal, life-threatening or potentially fatal bleeding requiring blood transfusion or surgical intervention

  4. Incidence of slight hemorrhage [ Time Frame: 2 year ]
    Obvious or recessive gastrointestinal bleeding, hemoptysis, nosebleeds, gross hematuria, subcutaneous congestion, anemia caused by blood loss, moderate chronic blood loss

  5. Usability of the AF telemedicine platform intervention for patients [ Time Frame: 4 months ]

    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.

  6. Changes of self-management [ Time Frame: 4 months ]

    Lifestyle changes Assessment Scale:

    Lifestyle and health behaviors of participants were collected by interview. Diet: Low-salt, low-fat, low-sugar, abstinence/reduce alcohol intake, more fruits and vegetables Self-monitoring: Blood pressure, weight Medicine adherence: In right dose, at right time Strongly in conformity 1 2 3 4 5 6 7 Strongly conformity For each independent assignment, a higher score means better outcome.


  7. Engagement of the intervention [ Time Frame: 4 months ]
    It was assessed objectively via daily Web portal log-ins and use of the mobile APP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127799


Contacts
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Contact: Xiang Gu, Doctor +86 0514 87373366 sbyygx@medmail.com.cn
Contact: Hongxiao Li, Doctor +86 0514 87373367 lhxlmt@126.com

Locations
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China, Jiangsu
Department of cardiovascular medicine,Northern Jiangsu Hospital Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Hongxiao Li, Doctor    +86 0514 87373367      
Sub-Investigator: Lei Sun, Master         
Sub-Investigator: Ye Zhu, Master         
Sub-Investigator: Shuhang Miao, Bachelor         
Sub-Investigator: Yi Zhang, Master         
Sub-Investigator: Zhengyu Bao, Doctor         
Sub-Investigator: Jianhua Shen, Master         
Sub-Investigator: Fukun Chen, Bachler         
Sub-Investigator: Xiaolin Sun, Master         
Sponsors and Collaborators
Northern Jiangsu Province People's Hospital
Investigators
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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

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Responsible Party: Xiang Gu, Director of cardiology, Northern Jiangsu Province People's Hospital
ClinicalTrials.gov Identifier: NCT04127799     History of Changes
Other Study ID Numbers: BL2019083
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes