TelemedicineNCT04127799
Integrative Management of Patients With Atrial Fibrillation Via Hospital-Community-Family-Based Telemedicine (HCFT-AF) Program
A study testing Hospital-Community-Family-Care Management Platform Online and Subjects with AF conventional treatment in people with Telemedicine and Atrial Fibrillation, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine, Atrial Fibrillation
- What is being tested?
- Hospital-Community-Family-Care Management Platform Online and Subjects with AF conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of cardiovascular medicine,Northern Jiangsu Hospital
Yangzhou, Jiangsu, 225001
Hongxiao Li, Doctor, +86 0514 87373367
Lei Sun, Master
About this study
Official title: 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.
Read the 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
- Being tested
- Hospital-Community-Family-Care Management Platform Online, Subjects with AF conventional treatment
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital-Community-Family-Care Management Platform OnlineOther
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 treatmentOther
Subjects with standardized treatment according to latest guidelines via conventional visit.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-Community-Family-Care Management Platform Online | Experimental | 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 Receives: Other: Hospital-Community-Family-Care Management Platform Online; Other: Subjects with AF conventional treatment |
| Subjects with AF conventional treatment | Active comparator | Subjects with AF via conventional clinic visit according to the latest relevant guidelines Receives: Other: Subjects with AF conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of ischemic stroke
Measured: 1 year
The incidence of ischemic stroke
Measured: 2 year
Cardiovascular mortality
Measured: 1 year
Cardiovascular mortality
Measured: 2 year
all-cause mortality
Measured: 1 year
all-cause mortality
Measured: 2 year
Secondary outcomes (8)
Incidence of systemic embolism
Systemic embolism (Limb, kidney, mesenteric artery, lung, retina, etc. must be confirmed by vascular ultrasound, angiography, surgery or biopsy)
Measured: 2 year
Incidence of transient ischemic attack
Measured: 2 year
Incidence of severe hemorrhage
Fatal, life-threatening or potentially fatal bleeding requiring blood transfusion or surgical intervention
Measured: 2 year
Incidence of slight hemorrhage
Obvious or recessive gastrointestinal bleeding, hemoptysis, nosebleeds, gross hematuria, subcutaneous congestion, anemia caused by blood loss, moderate chronic blood loss
Measured: 2 year
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.
Measured: 4 months
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.
Measured: 4 months
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)
Measured: 4 months
Engagement of the intervention
It was assessed objectively via daily Web portal log-ins and use of the mobile APP
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Nov 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Gu, Northern Jiangsu People's Hospital
- Investigators
- Lei Sun, Master, Study director, Department of cardiovascular medicineYe Zhu, Doctor, Principal investigator, Department of cardiovascular medicineXiaolin Sun, Doctor, Principal investigator, Department of cardiovascular medicineJiang Jiang, Master, Principal investigator, Department of cardiovascular medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127799
- Sponsor's protocol ID
- BL2019083
- Status last verified
- Feb 2020
- First submitted
- 30 Sep 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33084588
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern Jiangsu Province People's Hospital
- ClinicalTrials.gov ID
- NCT04127799
- Acronym / sponsor ID
- BL2019083
- Conditions
- Telemedicine, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital-Community-Family-Care Management Platform Online | Experimental | Other: Hospital-Community-Family-Care Management Platform Online, Other: Subjects with AF conventional treatmentHospital-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 comparator | Other: Subjects with AF conventional treatmentSubjects with AF via conventional clinic visit according to the latest relevant guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital-Community-Family-Care Management Platform OnlineSubjects 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 | Hospital-Community-Family-Care Management Platform Online |
| Subjects with AF conventional treatmentSubjects with standardized treatment according to latest guidelines via conventional visit. | Other | Hospital-Community-Family-Care Management Platform Online, Subjects with AF conventional treatment |
Primary outcome
The incidence of ischemic stroke
Time frame: 1 year
The incidence of ischemic stroke
Time frame: 2 year
Cardiovascular mortality
Time frame: 1 year
Cardiovascular mortality
Time frame: 2 year
all-cause mortality
Time frame: 1 year
all-cause mortality
Time frame: 2 year
8 secondary outcomes
Incidence of systemic embolism
Time frame: 2 year
Incidence of transient ischemic attack
Time frame: 2 year
Incidence of severe hemorrhage
Time frame: 2 year
Incidence of slight hemorrhage
Time frame: 2 year
Usability of the AF telemedicine platform intervention for patients
Time frame: 4 months
Changes of lifestyles and healthy behaviors
Time frame: 4 months
Drug adherence
Time frame: 4 months
Engagement of the intervention
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 33084588Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Sun, Master study director
Department of cardiovascular medicine
Ye Zhu, Doctor principal investigator
Department of cardiovascular medicine
Xiaolin Sun, Doctor principal investigator
Department of cardiovascular medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital-Community-Family-Care Management Platform Online and Subjects with AF conventional treatment in people with Telemedicine and Atrial Fibrillation, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Gu, Doctor (+86 0514 87373366, sbyygx@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of ischemic stroke (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.