Anticoagulant-induced Bleeding, Warfarin Sodium Causing Adverse Effects in Therapeutic Use
Conditions
Keywords
Artificial intelligence, social software, warfarin, anticoagulation therapy, INR
Brief summary
The investigators have demonstrated that social software could improve warfarin therapy quality by Human management. however,the efficiency of management will decline if patients' number expands huge. So it is needed that a human-like and automatic management tool could replace the human work. The aim of this study is to evaluate whether an AI-based social software management model could replace human to guide warfarin therapy.
Detailed description
1. The investigators have developed an AI-based miniprogram, and embedded in the Wechat social application. 2. The investigators invited patients receiving warfarin therapy to participant this randomized controlled trial . 3. Participants were randomized to the experimental group and control group in a ratio of 1:1. 4. Participants' warfarin therapy were managed by an AI-based social miniprogram and a Human-based social miniprogram respectively. 5. International normalized ratio(INR) was monitored once a month at least, and the time in therapeutic range was calculated to evaluate the warfarin anticoagulation quality. 6. Participants were followed-up for 24 months, and clinical events, including major bleedings and thrombotic events were recorded during follow-up.
Interventions
BEHAVIORALAI-based social software management model
a AI-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
BEHAVIORALHuman-based social software management model
a Human-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
Sponsors
Wuhan Asia Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants did not know whether they were assigned to AI-SMART group or Human-SMART group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Atrial fibrillation * Patients with Mechanical valve replacement * Patients receiving warfarin therapy
Exclusion criteria
* Plan to stop warfarin therapy within 1 years * Bleeding within 3 months * Refuse to participate in this study * Other conditions that the physician considers inappropriate for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in therapeutic range | 24 months | Calculated Time of international normalized ratio in therapeutic range |
| INR variability | 24 months | coefficient of variation of international normalized ratio (INR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombotic events | 24 months | Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al |
| Bleeding events | 24 months | Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding |
Countries
China
Outcome results
None listed