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

June 11, 2020 updated by: Xiang Gu, Northern Jiangsu Province People's Hospital

Northern Jiangsu Province People's Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Hongxiao Li, Doctor
  • Phone Number: +86 0514 87373367
  • Email: lhxlmt@126.com

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Department of cardiovascular medicine,Northern Jiangsu Hospital
        • Contact:
          • Hongxiao Li, Doctor
          • Phone Number: +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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cardiovascular mortality
Time Frame: 1 year
1 year
all-cause mortality
Time Frame: 1 year
1 year
The incidence of ischemic stroke
Time Frame: 1 year
1 year
The incidence of ischemic stroke
Time Frame: 2 year
2 year
Cardiovascular mortality
Time Frame: 2 year
2 year
all-cause mortality
Time Frame: 2 year
2 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 year
Incidence of transient ischemic attack
Time Frame: 2 year
2 year
Incidence of severe hemorrhage
Time Frame: 2 year
Fatal, life-threatening or potentially fatal bleeding requiring blood transfusion or surgical intervention
2 year
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
2 year
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.
4 months
Changes of lifestyles and healthy behaviors
Time Frame: 4 months
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.
4 months
Drug adherence
Time Frame: 4 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Jiangsu Province People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BL2019083

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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