Anticoagulant-induced BleedingAI-SMARTNCT03870581
AI-based Social Software to Manage wARfarin Therapy
A study testing AI-based social software management model and Human-based social software management model in people with Anticoagulant-induced Bleeding and Warfarin Sodium Causing Adverse Effects in Therapeutic Use, run by Wuhan Asia Heart Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anticoagulant-induced Bleeding, Warfarin Sodium Causing Adverse Effects in Therapeutic Use
- What is being tested?
- AI-based social software management model and Human-based social software management model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2019to 1 May 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Atrial fibrillation
- Patients with Mechanical valve replacement
- Patients receiving warfarin therapy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
WAHH
Wuhan, Hubei, 430000
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
About this study
Official title: Artificial Intelligence-based Social Software Management Model to Improve Warfarin Anticoagulation Therapy: a Prospective, Single-blind, Randomized Control Trial
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.
Read the detailed description
- The investigators have developed an AI-based miniprogram, and embedded in the Wechat social application.
- The investigators invited patients receiving warfarin therapy to participant this randomized controlled trial .
- Participants were randomized to the experimental group and control group in a ratio of 1:1.
- Participants' warfarin therapy were managed by an AI-based social miniprogram and a Human-based social miniprogram respectively.
- 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.
- Participants were followed-up for 24 months, and clinical events, including major bleedings and thrombotic events were recorded during follow-up.
- Conditions
- Anticoagulant-induced Bleeding, Warfarin Sodium Causing Adverse Effects in Therapeutic Use
- Being tested
- AI-based social software management model, Human-based social software management model
- Keywords
- Artificial intelligence, social software, warfarin, anticoagulation therapy, INR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based social software management modelBehavioural
Also called Warfarin Helper-AI
a AI-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
Human-based social software management modelBehavioural
Also called Warfarin Helper
a Human-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
| Study group | Role | What they receive |
|---|---|---|
| AI-SMART group | Experimental | Participants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software. Receives: Behavioral: AI-based social software management model |
| Human-SMART group | Active comparator | Participants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software. Receives: Behavioral: Human-based social software management model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in therapeutic range
Calculated Time of international normalized ratio in therapeutic range
Measured: 24 months
INR variability
coefficient of variation of international normalized ratio (INR)
Measured: 24 months
Secondary outcomes (2)
Bleeding events
Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding
Measured: 24 months
Thrombotic events
Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 May 2019 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulant-induced BleedingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Litao Zhang, MD, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870581
- Sponsor's protocol ID
- 2019-P-012
- Acronym
- AI-SMART
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Social Software Management Model to Improve Warfarin Anticoagulation Therapy: a Prospective, Single-blind, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03870581
- Acronym / sponsor ID
- AI-SMART / 2019-P-012
- Conditions
- Anticoagulant-induced Bleeding, Warfarin Sodium Causing Adverse Effects in Therapeutic Use
- Keywords
- Artificial intelligence, social software, warfarin, anticoagulation therapy, INR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 12 Mar 2019 (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.
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
- The investigators have developed an AI-based miniprogram, and embedded in the Wechat social application.
- The investigators invited patients receiving warfarin therapy to participant this randomized controlled trial .
- Participants were randomized to the experimental group and control group in a ratio of 1:1.
- Participants' warfarin therapy were managed by an AI-based social miniprogram and a Human-based social miniprogram respectively.
- 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.
- Participants were followed-up for 24 months, and clinical events, including major bleedings and thrombotic events were recorded during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-SMART group | Experimental | Behavioral: AI-based social software management modelParticipants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software. |
| Human-SMART group | Active comparator | Behavioral: Human-based social software management modelParticipants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Atrial fibrillation
- Patients with Mechanical valve replacement
- Patients receiving warfarin therapy
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| AI-based social software management modelAlso: Warfarin Helper-AIa AI-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc. | Behavioural | AI-SMART group |
| Human-based social software management modelAlso: Warfarin Helpera Human-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc. | Behavioural | Human-SMART group |
Primary outcome
Time in therapeutic range
Time frame: 24 months
Calculated Time of international normalized ratio in therapeutic range
INR variability
Time frame: 24 months
coefficient of variation of international normalized ratio (INR)
2 secondary outcomes
Bleeding events
Time frame: 24 months
Thrombotic events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based social software management model and Human-based social software management model in people with Anticoagulant-induced Bleeding and Warfarin Sodium Causing Adverse Effects in Therapeutic Use, run by Wuhan Asia Heart Hospital at 2 sites 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 3 inclusion and 4 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in therapeutic range (time frame: 24 months). The study lists 2 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 12 Mar 2019.