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

Primary Purpose

Telemedicine, Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hospital-Community-Family-Care Management Platform Online
Subjects with AF conventional treatment
Sponsored by
Northern Jiangsu Province People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Department of cardiovascular medicine,Northern Jiangsu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hospital-Community-Family-Care Management Platform Online

Subjects with AF conventional treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

The incidence of ischemic stroke
The incidence of ischemic stroke
Cardiovascular mortality
Cardiovascular mortality
all-cause mortality
all-cause mortality

Secondary Outcome Measures

Incidence of systemic embolism
Systemic embolism (Limb, kidney, mesenteric artery, lung, retina, etc. must be confirmed by vascular ultrasound, angiography, surgery or biopsy)
Incidence of transient ischemic attack
Incidence of severe hemorrhage
Fatal, life-threatening or potentially fatal bleeding requiring blood transfusion or surgical intervention
Incidence of slight hemorrhage
Obvious or recessive gastrointestinal bleeding, hemoptysis, nosebleeds, gross hematuria, subcutaneous congestion, anemia caused by blood loss, moderate chronic blood loss
Usability of the AF telemedicine platform intervention for patients
Perceived Health Web Site Usability Questionnaire (PHWSUQ)[1] Ease of finding specific information Ease of reading the information given Ease of listening to audio-information Overall appearance of the site Overall quality of graphics Quality of video information Ease-of-Use I found the use of this Web site easy to learn. Finding information on this Web site requires a lot of mental effort. Overall, I find this Web site is easy to use. Usefulness Using this Web site will help me understand specific health problem(s). Using this Web site will help me improve my knowledge about health. 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.
Changes of lifestyles and healthy behaviors
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.
Drug adherence
Patients drug adherence was assessed via the Pharmacy Quality Alliance adherence measure at baseline and 4 months individually. Pharmacy Quality Alliance adherence measure I am convinced of the importance of my prescription medication I worry that my prescription medication will do more harm than good to me 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)
Engagement of the intervention
It was assessed objectively via daily Web portal log-ins and use of the mobile APP

Full Information

First Posted
September 30, 2019
Last Updated
June 11, 2020
Sponsor
Northern Jiangsu Province People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04127799
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Jiangsu Province People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine, Atrial Fibrillation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hospital-Community-Family-Care Management Platform Online
Arm Type
Experimental
Arm Description
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
Arm Title
Subjects with AF conventional treatment
Arm Type
Active Comparator
Arm Description
Subjects with AF via conventional clinic visit according to the latest relevant guidelines
Intervention Type
Other
Intervention Name(s)
Hospital-Community-Family-Care Management Platform Online
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Subjects with AF conventional treatment
Intervention Description
Subjects with standardized treatment according to latest guidelines via conventional visit.
Primary Outcome Measure Information:
Title
The incidence of ischemic stroke
Time Frame
1 year
Title
The incidence of ischemic stroke
Time Frame
2 year
Title
Cardiovascular mortality
Time Frame
1 year
Title
Cardiovascular mortality
Time Frame
2 year
Title
all-cause mortality
Time Frame
1 year
Title
all-cause mortality
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Incidence of systemic embolism
Description
Systemic embolism (Limb, kidney, mesenteric artery, lung, retina, etc. must be confirmed by vascular ultrasound, angiography, surgery or biopsy)
Time Frame
2 year
Title
Incidence of transient ischemic attack
Time Frame
2 year
Title
Incidence of severe hemorrhage
Description
Fatal, life-threatening or potentially fatal bleeding requiring blood transfusion or surgical intervention
Time Frame
2 year
Title
Incidence of slight hemorrhage
Description
Obvious or recessive gastrointestinal bleeding, hemoptysis, nosebleeds, gross hematuria, subcutaneous congestion, anemia caused by blood loss, moderate chronic blood loss
Time Frame
2 year
Title
Usability of the AF telemedicine platform intervention for patients
Description
Perceived Health Web Site Usability Questionnaire (PHWSUQ)[1] Ease of finding specific information Ease of reading the information given Ease of listening to audio-information Overall appearance of the site Overall quality of graphics Quality of video information Ease-of-Use I found the use of this Web site easy to learn. Finding information on this Web site requires a lot of mental effort. Overall, I find this Web site is easy to use. Usefulness Using this Web site will help me understand specific health problem(s). Using this Web site will help me improve my knowledge about health. 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.
Time Frame
4 months
Title
Changes of lifestyles and healthy behaviors
Description
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.
Time Frame
4 months
Title
Drug adherence
Description
Patients drug adherence was assessed via the Pharmacy Quality Alliance adherence measure at baseline and 4 months individually. Pharmacy Quality Alliance adherence measure I am convinced of the importance of my prescription medication I worry that my prescription medication will do more harm than good to me 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)
Time Frame
4 months
Title
Engagement of the intervention
Description
It was assessed objectively via daily Web portal log-ins and use of the mobile APP
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Gu, Doctor
Phone
+86 0514 87373366
Email
sbyygx@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongxiao Li, Doctor
Phone
+86 0514 87373367
Email
lhxlmt@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Sun, Master
Organizational Affiliation
Department of cardiovascular medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ye Zhu, Doctor
Organizational Affiliation
Department of cardiovascular medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaolin Sun, Doctor
Organizational Affiliation
Department of cardiovascular medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiang Jiang, Master
Organizational Affiliation
Department of cardiovascular medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of cardiovascular medicine,Northern Jiangsu Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxiao Li, Doctor
Phone
+86 0514 87373367
First Name & Middle Initial & Last Name & Degree
Lei Sun, Master
First Name & Middle Initial & Last Name & Degree
Ye Zhu, Master
First Name & Middle Initial & Last Name & Degree
Shuhang Miao, Bachelor
First Name & Middle Initial & Last Name & Degree
Yi Zhang, Master
First Name & Middle Initial & Last Name & Degree
Zhengyu Bao, Doctor
First Name & Middle Initial & Last Name & Degree
Jianhua Shen, Master
First Name & Middle Initial & Last Name & Degree
Fukun Chen, Bachler
First Name & Middle Initial & Last Name & Degree
Xiaolin Sun, Master

12. IPD Sharing Statement

Citations:
PubMed Identifier
33084588
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.
Results Reference
derived

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

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