Artificial Intelligence to Measure Adherence to Oral Medication

May 24, 2023 updated by: Northwell Health

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 months
Provides participant utilization of psychiatric ER visits or psychiatric hospitalization
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe