An interventional study of Use of "I-Anticoagulation" to make the decision and manage patients in Atrial Fibrillation and Anticoagulants, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Other
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 440 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Use of "I-Anticoagulation" to make the decision and manage patients
AF patients in the control group will receive standard care.
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.
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.
Time frame: 1st, 3rd, 6th, 9th, and 12th months
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.
Time frame: 1st, 3rd, 6th, 9th, and 12th months
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.
Time frame: 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.
Time frame: 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.
Time frame: 1st, 3rd, 6th, 9th, and 12th months
OAC adherence of AF patients receiving anticoagulation therapy
The MARS-5 assesses common patterns of nonadherent behavior.
Time frame: 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.
Time frame: 1st, 3rd, 6th, 9th, and 12th months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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