Artificial Intelligence to Measure Adherence to Oral Medication

Early-phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO) - Using Artificial Intelligence to Measure Adherence to Oral Medication

The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.

Study Overview

• Status: Recruiting
• Conditions: First Episode Psychosis
• Intervention / Treatment: Other: Smartphone App; Other: Usual Care

Detailed Description

The challenge of oral medication adherence in first-episode psychosis (as in any potentially chronic illness) is enormous, and numerous studies have linked non-adherence to increased rates of relapse/ hospitalization. Determining whether a patient is adhering to medication is a challenge. Pill counts, pharmacy records, technology-assisted monitoring, biological assays, and a range of self-report and interviewer-rated scales have been employed. In other areas of medicine such as antiretroviral treatment Direct Observation of Treatment (DOT) has been employed with excellent success both in monitoring and demonstrated improvement of important clinical outcomes. DOT is clearly not feasible in community settings. An artificial Intelligence (AI) platform that can be downloaded as an application onto a smart phone app represents a novel approach to offering DOT to support participant oral medication adherence and thereby improve outcomes. Aims of the project are: 1) to document acceptability to patients of the AI smartphone app based upon participation in the study and 2) to compare rates of hospitalization and emergency room visits between participants who receive the AI smartphone app with participants who receive standard care.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patricia Marcy, BSN; Phone Number: 347-439-8035; Email: pmarcy@northwell.edu
• Study Contact Backup: Name: Cristina Gonzalez, MS; Phone Number: 347-804-3605

Study Locations

• United States
  • Florida
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • Citrus Health
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • InterAct
      • Contact: Jacob Gonzalez
    • Kalamazoo, Michigan, United States, 49007
      • Recruiting
      • InterAct of Michigan
      • Contact: Dana Schrader
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73105
      • Recruiting
      • Red Rock
    • Tulsa, Oklahoma, United States, 74315
      • Recruiting
      • Family and Children's Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Enrolled in a CSC program
• Prescribed an oral antipsychotic

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone App; artificial intelligence (AI) smartphone app to provide support for medication adherence	Other: Smartphone App; artificial intelligence (AI) smartphone app to provide support for medication adherence
Active Comparator: Usual Care; Usual care provided at CSC clinic	Other: Usual Care; Usual Care provided by CSC clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Service Utilization Report Form	Provides participant utilization of psychiatric ER visits or psychiatric hospitalization	12 months

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 19-0307-ZHH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No