Atrial FibrillationAMS-AFNCT05316870
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
A study testing Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions and Conventional general practitioner management model in people with Atrial Fibrillation, run by Beijing Municipal Health Commission at 1 site in China.
Trial summary
Study types and hypotheses: multicenter randomized controlled trials. This study predicts that standardized anticoagulation management of atrial fibrillation in primary health care institutions can reduce the prevalence of atrial fibrillation stroke by 50%. 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions and Conventional general practitioner management model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2020to 31 Dec 2022
- 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, regardless of sex.
- It is consistent with the diagnostic basis of atrial fibrillation in "Atrial Fibrillation: current Cognition and treatment recommendations-2018".
- Receive oral anticoagulant therapy, such as warfarin or NOACs, as needed.
- There is a contracted family doctor (if not, they can be included in the study after guiding them to sign up for a family doctor).
- Have certain reading comprehension ability, be able to follow up regularly, have good compliance, and select the residents living in the vicinity.
- Volunteer to participate in this clinical study and sign a written informed consent form
Who cannot join
- Other diseases requiring anticoagulant therapy, such as pulmonary embolism, were included in the group.
- Suffer from severe mental illness or serious diseases that affect their survival, such as AIDS.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuetan Community Health Service Center Fu Xing Hospital, Capital Medical University
Beijing, Beijing Municipality, 0086
xia J Wang, Master, 0086-18800159266 ext. 0086-68017528, 1457200352@qq.com
About this study
Official title: Construction and Evaluation of Standardized Anticoagulant Management Model of Atrial Fibrillation in Primary Medical Institutions Under Hierarchical Diagnosis and Treatment System
Study types and hypotheses: multicenter randomized controlled trials. This study predicts that standardized anticoagulation management of atrial fibrillation in primary health care institutions can reduce the prevalence of atrial fibrillation stroke by 50%.
- Formulation and revision of standardized anticoagulation management plan and process for atrial fibrillation in primary health care institutions. Using the mature anticoagulation management model of atrial fibrillation for reference, based on the clinical data and disease management needs of patients with atrial fibrillation in five community health service centers in Xicheng District of Beijing. To formulate the anticoagulation management plan and process of atrial fibrillation suitable for grass-roots medical institutions. After the completion of the first draft of anticoagulation management plan and process, two rounds of multi-disciplinary experts were organized to demonstrate the feasibility and scientific nature of the first draft. Finally, based on the practice and effect evaluation of clinical application management, the scheme is revised and improved.
- To evaluate the feasibility and clinical application effect of standardized anticoagulation management scheme and process for atrial fibrillation.
First of all, the baseline clinical database of patients with multicenter atrial fibrillation was established; secondly, patients with atrial fibrillation who met the entry criteria were randomly included in the trial group or control group and followed up for two years. The anticoagulation treatment rate, the incidence of bleeding and thromboembolic events, anticoagulation compliance rate and knowledge awareness rate of atrial fibrillation in the two groups were compared, and the effect of standardized anticoagulation management of atrial fibrillation in primary medical institutions was evaluated.
Read the detailed description
To organize experts to formulate a standardized anticoagulation management plan and process for atrial fibrillation in grass-roots medical institutions
- Write the first draft of "standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions" By searching the anticoagulation management guidelines and expert consensus of atrial fibrillation at home and abroad, do a comparative study, determine the main points of anticoagulation management; analyzing the baseline clinical database of patients with multicenter atrial fibrillation, combined with quantitative and qualitative research, to explore the anticoagulation management needs of patients with atrial fibrillation. Based on the above results, the first draft of standardized anticoagulation management plan and process of atrial fibrillation in grass-roots medical institutions was written.
- Organize expert group interviews. A multidisciplinary expert group was identified, including cardiology, neurology, general medicine, nursing and pharmacy, with 1 or 2 middle-level and above professionals selected in each discipline. Design the interview outline, according to the interview outline, a senior general practitioner encourages and guides the team members to express their own views on the subject. The main contents include: how scientific is this anticoagulation management scheme? What is the value of clinical application? What are the difficulties in the implementation process? What are the contents that need to be further improved?
- Revision and improvement of "standardized anticoagulation management scheme and process for atrial fibrillation in primary medical institutions" According to the results of the expert group interview, revise and further improve the "standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions" to generate the final intervention plan.
To evaluate the clinical effect of standardized anticoagulation management scheme and process for atrial fibrillation.
- Observation indicators Main outcome measures: the rate of anticoagulant therapy, the rate of reaching the standard of INR, the incidence of bleeding and thromboembolic events at 3 months, 6 months, 9 months, 12 months, 18 months and 24 months. Secondary indicators: anticoagulant compliance rate and knowledge awareness rate of atrial fibrillation at 6 months, 12 months and 18 months. Blood routine: hemoglobin, platelet; biochemistry: glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, serum creatinine, urea nitrogen, glomerular filtration rate; electrocardiogram / dynamic electrocardiogram, echocardiography.
- Follow-up plan Patients' symptoms and signs, diet and exercise in the process of anticoagulation management were followed up once a month, and when unmanageable new symptoms or drug side effects appeared, they were referred to secondary or tertiary hospitals for treatment in time; a regular comprehensive physical examination was arranged once a year, including blood routine, biochemical, ECG / dynamic electrocardiogram, echocardiography, etc., and the follow-up period was 2 years.
- Conditions
- Atrial Fibrillation
- Being tested
- Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions, Conventional general practitioner management model
- Keywords
- Atrial fibrillation, Anticoagulation management plan and process, Primary medical institutions
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutionsBehavioural
Compared with the current anticoagulation management service, we pay more attention to early initiation of anticoagulant therapy and long-term follow-up management.
Conventional general practitioner management modelBehavioural
The current general practitioner anticoagulation management model was continued in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The standardized anticoagulation management program of atrial fibrillation in primary medical institutions was implemented for the patients with atrial fibrillation in the intervention group. Receives: Behavioral: Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions |
| Control group | Other | The current general practitioner management mode was continued for the patients with atrial fibrillation in the control group. Receives: Behavioral: Conventional general practitioner management model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticoagulant treatment rate, %
Anticoagulant therapy rate (%) = number of people actually receiving anticoagulant therapy / number of people who should receive anticoagulant therapy x 100%anticoagulant therapy / the total number of people who should receive anticoagulant therapy x 100%.
Measured: Change from Baseline Anticoagulant treatment rate at 24 months
Incidence of bleeding and thromboembolic events
Incidence of thromboembolic events / anticoagulation related bleeding events (%) = number of thromboembolic events / anticoagulation related bleeding events in a certain period / number of people observed in the same period x 100% (unit: person year)
Measured: Change from Baseline bleeding and thromboembolic events rate at 24 months
INR compliance rate
INR compliance rate (%) = the number of INR compliance (2.0 / 3.0) / the total number of INR monitored in the same period × 100%
Measured: Change from 12 months INR compliance rate at 24 months
Secondary outcomes (2)
Anticoagulant compliance rate
Using the Chinese revised version of Morisky Drug Compliance scale
Measured: Change from 12 months INR compliance rate at 24 months
Knowledge awareness rate of atrial fibrillation
Awareness rate = the number of correct questions answered by the respondents / the total number of questions answered by the respondents x 100%.
Measured: Change from 12 months INR compliance rate at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start4 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each community health service center randomly included patients with atrial fibrillation who met the admission criteria into the trial group or the control group. The intervention measures are the standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Health Commission
- Sponsor type
- Other government
- Collaborators
- Exhibition Road Community Health Service Center of Xicheng District, Beijing, China, Xinjiekou Community Health Service Center of Xicheng District, Beijing, China, Guanwai Community Health Service Center of Xicheng District, Beijing, China, Guannei Community Health Service Center of Xicheng District, Beijing, China
- Responsible party
- Sponsor
- Investigators
- Xia J Wang, Master, Study chair, FuXing Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316870
- Sponsor's protocol ID
- CFH 2020-4-7025
- Acronym
- AMS-AF
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of Standardized Anticoagulant Management Model of Atrial Fibrillation in Primary Medical Institutions Under Hierarchical Diagnosis and Treatment System
- ClinicalTrials.gov ID
- NCT05316870
- Acronym / sponsor ID
- AMS-AF / CFH 2020-4-7025
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Anticoagulation management plan and process, Primary medical institutions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Beijing Municipal Health CommissionOther government
- Collaborators
- Exhibition Road Community Health Service Center of Xicheng District, Beijing, China, Xinjiekou Community Health Service Center of Xicheng District, Beijing, China, Guanwai Community Health Service Center of Xicheng District, Beijing, China, Guannei Community Health Service Center of Xicheng District, Beijing, China
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Apr 2022 (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.
Study types and hypotheses: multicenter randomized controlled trials. This study predicts that standardized anticoagulation management of atrial fibrillation in primary health care institutions can reduce the prevalence of atrial fibrillation stroke by 50%.
- Formulation and revision of standardized anticoagulation management plan and process for atrial fibrillation in primary health care institutions. Using the mature anticoagulation management model of atrial fibrillation for reference, based on the clinical data and disease management needs of patients with atrial fibrillation in five community health service centers in Xicheng District of Beijing. To formulate the anticoagulation management plan and process of atrial fibrillation suitable for grass-roots medical institutions. After the completion of the first draft of anticoagulation management plan and process, two rounds of multi-disciplinary experts were organized to demonstrate the feasibility and scientific nature of the first draft. Finally, based on the practice and effect evaluation of clinical application management, the scheme is revised and improved.
- To evaluate the feasibility and clinical application effect of standardized anticoagulation management scheme and process for atrial fibrillation.
First of all, the baseline clinical database of patients with multicenter atrial fibrillation was established; secondly, patients with atrial fibrillation who met the entry criteria were randomly included in the trial group or control group and followed up for two years. The anticoagulation treatment rate, the incidence of bleeding and thromboembolic events, anticoagulation compliance rate and knowledge awareness rate of atrial fibrillation in the two groups were compared, and the effect of standardized anticoagulation management of atrial fibrillation in primary medical institutions was evaluated.
Detailed description
To organize experts to formulate a standardized anticoagulation management plan and process for atrial fibrillation in grass-roots medical institutions
- Write the first draft of "standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions" By searching the anticoagulation management guidelines and expert consensus of atrial fibrillation at home and abroad, do a comparative study, determine the main points of anticoagulation management; analyzing the baseline clinical database of patients with multicenter atrial fibrillation, combined with quantitative and qualitative research, to explore the anticoagulation management needs of patients with atrial fibrillation. Based on the above results, the first draft of standardized anticoagulation management plan and process of atrial fibrillation in grass-roots medical institutions was written.
- Organize expert group interviews. A multidisciplinary expert group was identified, including cardiology, neurology, general medicine, nursing and pharmacy, with 1 or 2 middle-level and above professionals selected in each discipline. Design the interview outline, according to the interview outline, a senior general practitioner encourages and guides the team members to express their own views on the subject. The main contents include: how scientific is this anticoagulation management scheme? What is the value of clinical application? What are the difficulties in the implementation process? What are the contents that need to be further improved?
- Revision and improvement of "standardized anticoagulation management scheme and process for atrial fibrillation in primary medical institutions" According to the results of the expert group interview, revise and further improve the "standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions" to generate the final intervention plan.
To evaluate the clinical effect of standardized anticoagulation management scheme and process for atrial fibrillation.
- Observation indicators Main outcome measures: the rate of anticoagulant therapy, the rate of reaching the standard of INR, the incidence of bleeding and thromboembolic events at 3 months, 6 months, 9 months, 12 months, 18 months and 24 months. Secondary indicators: anticoagulant compliance rate and knowledge awareness rate of atrial fibrillation at 6 months, 12 months and 18 months. Blood routine: hemoglobin, platelet; biochemistry: glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, serum creatinine, urea nitrogen, glomerular filtration rate; electrocardiogram / dynamic electrocardiogram, echocardiography.
- Follow-up plan Patients' symptoms and signs, diet and exercise in the process of anticoagulation management were followed up once a month, and when unmanageable new symptoms or drug side effects appeared, they were referred to secondary or tertiary hospitals for treatment in time; a regular comprehensive physical examination was arranged once a year, including blood routine, biochemical, ECG / dynamic electrocardiogram, echocardiography, etc., and the follow-up period was 2 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each community health service center randomly included patients with atrial fibrillation who met the admission criteria into the trial group or the control group. The intervention measures are the standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutionsThe standardized anticoagulation management program of atrial fibrillation in primary medical institutions was implemented for the patients with atrial fibrillation in the intervention group. |
| Control group | Other | Behavioral: Conventional general practitioner management modelThe current general practitioner management mode was continued for the patients with atrial fibrillation in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, regardless of sex.
- It is consistent with the diagnostic basis of atrial fibrillation in "Atrial Fibrillation: current Cognition and treatment recommendations-2018".
- Receive oral anticoagulant therapy, such as warfarin or NOACs, as needed.
- There is a contracted family doctor (if not, they can be included in the study after guiding them to sign up for a family doctor).
- Have certain reading comprehension ability, be able to follow up regularly, have good compliance, and select the residents living in the vicinity.
Key exclusion criteria (2 listed)
- Other diseases requiring anticoagulant therapy, such as pulmonary embolism, were included in the group.
- Suffer from severe mental illness or serious diseases that affect their survival, such as AIDS.
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 |
|---|---|---|
| Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutionsCompared with the current anticoagulation management service, we pay more attention to early initiation of anticoagulant therapy and long-term follow-up management. | Behavioural | Intervention group |
| Conventional general practitioner management modelThe current general practitioner anticoagulation management model was continued in the control group. | Behavioural | Control group |
Primary outcome
Anticoagulant treatment rate, %
Time frame: Change from Baseline Anticoagulant treatment rate at 24 months
Anticoagulant therapy rate (%) = number of people actually receiving anticoagulant therapy / number of people who should receive anticoagulant therapy x 100%anticoagulant therapy / the total number of people who should receive anticoagulant therapy x 100%.
Incidence of bleeding and thromboembolic events
Time frame: Change from Baseline bleeding and thromboembolic events rate at 24 months
Incidence of thromboembolic events / anticoagulation related bleeding events (%) = number of thromboembolic events / anticoagulation related bleeding events in a certain period / number of people observed in the same period x 100% (unit: person year)
INR compliance rate
Time frame: Change from 12 months INR compliance rate at 24 months
INR compliance rate (%) = the number of INR compliance (2.0 / 3.0) / the total number of INR monitored in the same period × 100%
2 secondary outcomes
Anticoagulant compliance rate
Time frame: Change from 12 months INR compliance rate at 24 months
Knowledge awareness rate of atrial fibrillation
Time frame: Change from 12 months INR compliance rate at 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Xia J Wang, Master study chair
FuXing Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions and Conventional general practitioner management model in people with Atrial Fibrillation, run by Beijing Municipal Health Commission 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 6 inclusion and 2 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 7 Apr 2022. 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 lan Ding, Bachelor (0086-13621031422 ext. 0086-68056002, ytzxkyb@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticoagulant treatment rate, % (time frame: Change from Baseline Anticoagulant treatment rate at 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2022.