StrokeNCT02599259
Using Artificial Intelligence to Measure and Optimize Adherence in Patients on Anticoagulation Therapy.
A study testing Monitored (M+) in people with Stroke, run by AiCure at 1 site in United States.
Trial summary
AiCure uses artificial intelligence and visual recognition technology to confirm medication ingestion. The software is available as an app and downloaded onto a smart phone. The single-site, parallel-arm, randomized controlled trial will test the feasibility and impact of using the platform in a stroke population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Monitored (M+)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male or female at least 18 years of age.
- Having a diagnosis of ischemic stroke.
- Has a score between 1 and 20 on the NIH Stroke Survey (NIHSS) at admission and upon enrollment at discharge from the index admission to the hospital or at first encounter in the outpatient stroke center.
- Is taking any one of the monitored drugs- Coumadin®, Pradaxa®, Xarelto® or Eliquis®.
- Is going home or to acute outpatient rehabilitation after discharge.
- Has sufficient capacity to provide consent or agree to assent.
- Has at least minimal mental capacity and motor skills.
Who cannot join
- Has poor fine motor skills, to preclude him/her from holding a pill steady in front of a camera.
- Has impaired visual or auditory faculties.
- Is being released to a nursing home, hospice or any other inpatient care facility.
- Has stable, therapeutic INRs on warfarin for at least one year.
- Has a mechanical mitral valve or left ventricular assist device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Artificial Intelligence on Mobile Devices to Automate Directly Observed Therapy (DOT), Confirm Medication Ingestion, and Optimize Treatment in Patients on Anticoagulation Therapy.
AiCure uses artificial intelligence and visual recognition technology to confirm medication ingestion. The software is available as an app and downloaded onto a smart phone. The single-site, parallel-arm, randomized controlled trial will test the feasibility and impact of using the platform in a stroke population. End points: usability, consistent use of the device, and optimization of treatment.
Read the detailed description
This study will employ a single-site, parallel-arm, and randomized trial design. A total of 50-100 human subjects- who have a diagnosis of ischemic stroke and taking any one of the following oral anticoagulant medication- Coumadin® (warfarin), Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban) will be recruited for the study. All participants will receive their doctor's treatment-as-usual. 1:1 randomization will be done at baseline, those in the +arm will have their medication adherence monitored by means of the AiCure platform, and the other participants will be assigned to the control arm of the study.
Study visits include a screening visit, one or two baseline visits (which ideally will occur between 7 and 14 days after the screening visit), and monthly visits for the 12 weeks following the last baseline visit. Randomization will occur during the final baseline visit. During the final baseline visit, patients assigned to the AiCure intervention arm will be provided training on the AiCure platform. While in the clinic, the participants will practice using the AiCure app by going through a detailed tutorial that consists of a number of interactive training steps. Participants will use a substitute placebo practice medication in order to complete the training tutorial.
Study participants will be reimbursed to cover their time and transportation costs in accordance with Institutional Review Board (IRB) guidelines.
For the length of the study, participants assigned to the AiCure intervention arm of the study will be requested to take each dose of their prescribed medication regimen using the AiCure app. Data from each dosing event will be saved onto the participant's device and encrypted data (including de-identified video and time and date of administration) will be automatically transmitted to the centralized dashboard. If the study participant takes a dose but does not use the AiCure app (self-reports by confirming administration over the phone to a Study Coordinator or manually self-reports on the AiCure App without going through the necessary steps), misses a dose (participant fails to take dose prior to 'time for next dose' message appears on the device), or uses the AiCure app incorrectly (usability error or suspicious behavior), the Study Coordinator and/or the AiCure team will intervene as detailed in the escalation protocol.
Real-time adherence data will be automatically transmitted to the cloud-based centralized dashboard for the intervention group. All subjects will have INR and DRVVT measured once a month (or more frequently if on warfarin) to monitor medication adherence using a point of care device and/or laboratory monitoring (upon Principal Investigator and hematologist's discretion) at the clinic visit. All participants will get their prescription refills at their monthly visits. In addition, pill counts will be done for all participants. If adherence is sub-optimal based on pill count, the study coordinator will document the participant's self-reported reasons for sub-optimal adherence. In addition, participants in the intervention group will have their AiCure adherence rates reviewed by the assessing research staff, and any reasons provided by the subject for sub-optimal adherence will be recorded.
- Conditions
- Stroke
- Being tested
- Monitored (M+)
- Keywords
- Stroke, Oral anticoagulants, NOAC, wireless monitoring, Warfarin, Xarelto, compliance, adherence, monitoring, directly observed therapy, DOT, mobile device, electronic monitoring, artificial intelligence, oral anticoagulation therapy, adherence monitoring methods, nonadherence, non-adherence
- Medical subject headings
- Stroke, Patient Compliance, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitored (M+)Device
Also called AiCure, Automated DOT®, AiView®
Patients assigned to the intervention arm will use the AiCure Platform to monitor ingestion of all prescribed doses of oral anticoagulants. If a patient misses a dose, takes an incorrect dose, or their data are flagged for suspicious activity, they will be contacted by the Study Coordinator or AiCure study team.
| Study group | Role | What they receive |
|---|---|---|
| 1. Monitored (M+) | Experimental | Group receiving treatment as usual (TAU) and using the AiCure platform for monitoring and intervention platform on a mobile device being tested when taking their daily anticoagulation medication. Receives: Device: Monitored (M+) |
| Unmonitored (M-) | No intervention | No Intervention. Group receiving TAU and not issued mobile device with the AiCure platform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate acceptability and likability of the platform to patients and providers in providing real-time adherence monitoring.
Assess sustainability over 12 weeks by comparing number of prescribed doses to number of doses taken using the device.
Measured: 12 Weeks
Secondary outcomes (4)
Improved self-efficacy rates as measured by the SEAMS and BMQ questionnaires, administered at baseline and at the end of the study.
Improved self-efficacy rates as measured by the SEAMS and BMQ questionnaires, administered at baseline and at the end of the study.
Measured: 12 Weeks
Optimized treatment models based on regular monitoring of INR in desired target range of 2 - 3 and DRVVT in combination with real-time adherence data from the Automated DOT® platform
Maintenance of target INR of 2 to 3 in a stroke population taking oral anticoagulants.
Measured: 12 Weeks
Optimized treatment models based on regular monitoring of INR and DRVVT in combination with real-time adherence data from the Automated DOT® platform.
Maintenance of target DRVVT within a predetermined range by a stroke population taking oral anticoagulants.
Measured: 12 Weeks
Evaluate acceptability and utility through qualitative questionnaires.
Evaluate acceptability and utility through qualitative questionnaires.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiCure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Adam Hanina, MBA, Study director, AiCureDaniel Labovitz, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599259
- Sponsor's protocol ID
- AI-007.2
- Status last verified
- Jul 2016
- First submitted
- 25 Mar 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Labovitz DL, Shafner L, Reyes Gil M, Virmani D, Hanina A. Using Artificial Intelligence to Reduce the Risk of Nonadherence in Patients on Anticoagulation Therapy. Stroke. 2017 May;48(5):1416-1419. doi: 10.1161/STROKEAHA.116.016281. Epub 2017 Apr 6.
PubMed 28386037
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Artificial Intelligence on Mobile Devices to Automate Directly Observed Therapy (DOT), Confirm Medication Ingestion, and Optimize Treatment in Patients on Anticoagulation Therapy.
- ClinicalTrials.gov ID
- NCT02599259
- Acronym / sponsor ID
- AI-007.2
- Conditions
- Stroke
- Keywords
- Stroke, Oral anticoagulants, NOAC, wireless monitoring, Warfarin, Xarelto, compliance, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AiCureIndustry (pharma, biotech, devices)
- Collaborators
- Montefiore Medical Center
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Nov 2015 (estimated)
- 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.
AiCure uses artificial intelligence and visual recognition technology to confirm medication ingestion. The software is available as an app and downloaded onto a smart phone. The single-site, parallel-arm, randomized controlled trial will test the feasibility and impact of using the platform in a stroke population. End points: usability, consistent use of the device, and optimization of treatment.
Detailed description
This study will employ a single-site, parallel-arm, and randomized trial design. A total of 50-100 human subjects- who have a diagnosis of ischemic stroke and taking any one of the following oral anticoagulant medication- Coumadin® (warfarin), Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban) will be recruited for the study. All participants will receive their doctor's treatment-as-usual. 1:1 randomization will be done at baseline, those in the +arm will have their medication adherence monitored by means of the AiCure platform, and the other participants will be assigned to the control arm of the study.
Study visits include a screening visit, one or two baseline visits (which ideally will occur between 7 and 14 days after the screening visit), and monthly visits for the 12 weeks following the last baseline visit. Randomization will occur during the final baseline visit. During the final baseline visit, patients assigned to the AiCure intervention arm will be provided training on the AiCure platform. While in the clinic, the participants will practice using the AiCure app by going through a detailed tutorial that consists of a number of interactive training steps. Participants will use a substitute placebo practice medication in order to complete the training tutorial.
Study participants will be reimbursed to cover their time and transportation costs in accordance with Institutional Review Board (IRB) guidelines.
For the length of the study, participants assigned to the AiCure intervention arm of the study will be requested to take each dose of their prescribed medication regimen using the AiCure app. Data from each dosing event will be saved onto the participant's device and encrypted data (including de-identified video and time and date of administration) will be automatically transmitted to the centralized dashboard. If the study participant takes a dose but does not use the AiCure app (self-reports by confirming administration over the phone to a Study Coordinator or manually self-reports on the AiCure App without going through the necessary steps), misses a dose (participant fails to take dose prior to 'time for next dose' message appears on the device), or uses the AiCure app incorrectly (usability error or suspicious behavior), the Study Coordinator and/or the AiCure team will intervene as detailed in the escalation protocol.
Real-time adherence data will be automatically transmitted to the cloud-based centralized dashboard for the intervention group. All subjects will have INR and DRVVT measured once a month (or more frequently if on warfarin) to monitor medication adherence using a point of care device and/or laboratory monitoring (upon Principal Investigator and hematologist's discretion) at the clinic visit. All participants will get their prescription refills at their monthly visits. In addition, pill counts will be done for all participants. If adherence is sub-optimal based on pill count, the study coordinator will document the participant's self-reported reasons for sub-optimal adherence. In addition, participants in the intervention group will have their AiCure adherence rates reviewed by the assessing research staff, and any reasons provided by the subject for sub-optimal adherence will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Monitored (M+) | Experimental | Device: Monitored (M+)Group receiving treatment as usual (TAU) and using the AiCure platform for monitoring and intervention platform on a mobile device being tested when taking their daily anticoagulation medication. |
| Unmonitored (M-) | No intervention | –No Intervention. Group receiving TAU and not issued mobile device with the AiCure platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is male or female at least 18 years of age.
- Having a diagnosis of ischemic stroke.
- Has a score between 1 and 20 on the NIH Stroke Survey (NIHSS) at admission and upon enrollment at discharge from the index admission to the hospital or at first encounter in the outpatient stroke center.
- Is taking any one of the monitored drugs- Coumadin®, Pradaxa®, Xarelto® or Eliquis®.
- Is going home or to acute outpatient rehabilitation after discharge.
Key exclusion criteria (5 listed)
- Has poor fine motor skills, to preclude him/her from holding a pill steady in front of a camera.
- Has impaired visual or auditory faculties.
- Is being released to a nursing home, hospice or any other inpatient care facility.
- Has stable, therapeutic INRs on warfarin for at least one year.
- Has a mechanical mitral valve or left ventricular assist device.
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 |
|---|---|---|
| Monitored (M+)Also: AiCure, Automated DOT®, AiView®Patients assigned to the intervention arm will use the AiCure Platform to monitor ingestion of all prescribed doses of oral anticoagulants. If a patient misses a dose, takes an incorrect dose, or their data are flagged for suspicious activity, they will be contacted by the Study Coordinator or AiCure study team. | Device | 1. Monitored (M+) |
Primary outcome
To evaluate acceptability and likability of the platform to patients and providers in providing real-time adherence monitoring.
Time frame: 12 Weeks
Assess sustainability over 12 weeks by comparing number of prescribed doses to number of doses taken using the device.
4 secondary outcomes
Improved self-efficacy rates as measured by the SEAMS and BMQ questionnaires, administered at baseline and at the end of the study.
Time frame: 12 Weeks
Optimized treatment models based on regular monitoring of INR in desired target range of 2 - 3 and DRVVT in combination with real-time adherence data from the Automated DOT® platform
Time frame: 12 Weeks
Optimized treatment models based on regular monitoring of INR and DRVVT in combination with real-time adherence data from the Automated DOT® platform.
Time frame: 12 Weeks
Evaluate acceptability and utility through qualitative questionnaires.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Derived from this study: PubMed 28386037Labovitz DL, Shafner L, Reyes Gil M, Virmani D, Hanina A. Using Artificial Intelligence to Reduce the Risk of Nonadherence in Patients on Anticoagulation Therapy. Stroke. 2017 May;48(5):1416-1419. doi: 10.1161/STROKEAHA.116.016281. Epub 2017 Apr 6.
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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.
Adam Hanina, MBA study director
AiCure
Daniel Labovitz, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitored (M+) in people with Stroke, run by AiCure at 1 site in United States.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate acceptability and likability of the platform to patients and providers in providing real-time adherence monitoring. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599259, which also lists 1 linked publication.
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 Jul 2016.