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.
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.
- Monitored (M+) Device
Other Names: AiCure; Automated DOT®; AiView® Intervention Desc: 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. ARM 1: Kind: Experimental Label: 1. Monitored (M+) Description: 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.
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||To evaluate acceptability and likability of the platform to patients and providers in providing real-time adherence monitoring.||12 Weeks||No|
|Secondary||Improved self-efficacy rates as measured by the SEAMS and BMQ questionnaires, administered at baseline and at the end of the study.||12 Weeks||No|
|Secondary||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||12 Weeks||No|
|Secondary||Optimized treatment models based on regular monitoring of INR and DRVVT in combination with real-time adherence data from the Automated DOT® platform.||12 Weeks||No|
|Secondary||Evaluate acceptability and utility through qualitative questionnaires.||12 weeks||No|