Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this prospective, multicenter, cluster randomized controlled trial is to assess the effectiveness of a shared decision-making tool, "I-Anticoagulation", for anticoagulation management in AF patients. The main questions it aims to answer are:
The anticoagulation therapy of AF patients will be determined by clinicians with the use of "I-Anticoagulation", and AF patients will be managed using "I-Anticoagulation" during their anticoagulation therapy.
Researchers will compare the outcomes with the control group, in which patients with AF will receive standard care.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDM group | Experimental | The anticoagulation therapy of AF patients will be determined by clinicians with the use of "I-Anticoagulation", and AF patients will be managed using "I-Anticoagulation" during their anticoagulation therapy. |
|
| Control group | No Intervention | AF patients in the control group will receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of "I-Anticoagulation" to make the decision and manage patients | Other | I-Anticoagulation will offer a flexible and efficient communication platform for healthcare professionals and AF patients. The tool is composed of two modules: an anticoagulation decision support system and a full-process patient management system. |
| Measure | Description | Time Frame |
|---|---|---|
| Any bleeding events | Any bleeding events, including both major and minor bleeding events. Major bleeding events include fatal haemorrhage, life-threatening bleeding, and severe bleeding requiring treatment or assessment. Severe bleeding can manifest as gastric intestinal haemorrhage, joint haematoma, retroperitoneal haemorrhage, fundus haemorrhage, urine, haemoptysis, or require blood transfusion of at least two units. Minor bleeding events, such as mild nasal hemorrhage, endoscopic haematuria, skin stasis, or mild hemorrhoids, do not lead to serious consequences. | 1st, 3rd, 6th, 9th, and 12th months |
| Measure | Description | Time Frame |
|---|---|---|
| The accordance of stroke prophylaxis for AF according to current guidelines | The accordance of stroke prophylaxis for AF according to current guidelines, i.e., whether the prescriptions meet the recommendations on clinical guidelines, including the choice, usage and dosage of oral anticoagulants. | 1st, 3rd, 6th, 9th, and 12th months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| The percentage of time in the target INR range for patients using warfarin |
The percentage of time in which the INR remains in the 1.8 to 3.0 target range across time for patients using warfarin. |
| 1st, 3rd, 6th, 9th, and 12th months |
| The occurrences of major bleeding and thrombosis events | The occurrences of major bleeding and thrombosis events. Major bleeding events include fatal haemorrhage, life-threatening bleeding, and severe bleeding requiring treatment or assessment. Severe bleeding can manifest as gastric intestinal haemorrhage, joint haematoma, retroperitoneal haemorrhage, fundus haemorrhage, urine, haemoptysis, or require blood transfusion of at least two units. Thrombosis events, including ischaemic stroke, systemic embolism, and transient ischaemic attacks, will be confirmed by imaging methods such as ultrasound, CT, or MRI. | 1st, 3rd, 6th, 9th, and 12th months |
| OAC knowledge of AF patients receiving anticoagulation therapy | The AKT comprises 28 items assessing general anticoagulation knowledge for all available OAC and a specific section for VKAs therapy. | 1st, 3rd, 6th, 9th, and 12th months |
| OAC adherence of AF patients receiving anticoagulation therapy | The MARS-5 assesses common patterns of nonadherent behavior. | 1st, 3rd, 6th, 9th, and 12th months |
| Satisfaction of AF patients receiving anticoagulation therapy | The ACTS evaluates the burdens and benefits of anticoagulation treatment and its overall impact. | 1st, 3rd, 6th, 9th, and 12th months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |