Using Artificial Intelligence to Measure and Optimize Adherence in Patients on Anticoagulation Therapy.

NCT02599259 | Completed

• 1 other identifier: AI-007.2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. End points: usability, consistent use of the device, and optimization of treatment.

Conditions

Stroke

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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

  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.

  12 Weeks

• Evaluate acceptability and utility through qualitative questionnaires.

  12 weeks

Study Arms (2)

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.

Device: Monitored (M+)

Unmonitored (M-)

NO INTERVENTION

No Intervention. Group receiving TAU and not issued mobile device with the AiCure platform.

Interventions

Monitored (M+) DEVICE

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.

Also known as: AiCure, Automated DOT®, AiView®

1. Monitored (M+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AiCure: lead
• Montefiore Medical Center: collaborator

Study Sites (1)

Montefiore Medical Center

New York, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 28386037 DERIVED

MeSH Terms

Conditions

Stroke; Patient Compliance; Directly Observed Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Medication Adherence

Study Officials

• Adam Hanina, MBA

  AiCure

  STUDY DIRECTOR

• Daniel Labovitz, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: November 6, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

US (1)