Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation

NCT05316870 | Unknown

• 1 other identifier: CFH 2020-4-7025
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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. 1.Formulation and revision of standardized anticoagulation management plan and process for atrial fibrillation in primary health care institutions.
2. 2.To evaluate the feasibility and clinical application effect of standardized anticoagulation management scheme and process for atrial fibrillation.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Anticoagulation management plan and process; Primary medical institutions

Outcome Measures

Primary Outcomes (3)

• 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%.

  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)

  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%

  Change from 12 months INR compliance rate at 24 months

Secondary Outcomes (2)

• Anticoagulant compliance rate

  Change from 12 months INR compliance rate at 24 months

• Knowledge awareness rate of atrial fibrillation

  Change from 12 months INR compliance rate at 24 months

Study Arms (2)

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.

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.

Behavioral: Conventional general practitioner management model

Interventions

Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions BEHAVIORAL

Compared with the current anticoagulation management service, we pay more attention to early initiation of anticoagulant therapy and long-term follow-up management.

Intervention group

Conventional general practitioner management model BEHAVIORAL

The current general practitioner anticoagulation management model was continued in the control group.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Municipal Health Commission: lead
• Exhibition Road Community Health Service Center of Xicheng District, Beijing, China: collaborator
• Xinjiekou Community Health Service Center of Xicheng District, Beijing, China: collaborator
• Guanwai Community Health Service Center of Xicheng District, Beijing, China: collaborator
• Guannei Community Health Service Center of Xicheng District, Beijing, China: collaborator

Study Sites (1)

Yuetan Community Health Service Center Fu Xing Hospital, Capital Medical University

Beijing, Beijing Municipality, 0086, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xia J Wang, Master

  FuXing Hospital, Capital Medical University

  STUDY CHAIR

Central Study Contacts

lan Ding, Bachelor

CONTACT

0086-13621031422; ytzxkyb@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: April 7, 2022
• Study Start: September 4, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

CN (1)