Using Artificial Intelligence to Measure and Optimize Adherence in Patients on Anticoagulation Therapy.
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/13/2016 |
| Start Date: | March 2015 |
| End Date: | April 2016 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
New York, New York 10467
Principal Investigator: Daniel Labovitz, MD
Phone: 718-920-5412
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