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Clinical Trials/NCT04046497
NCT04046497
Recruiting
Phase 4

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

Northwell Health5 sites in 1 country200 target enrollmentNovember 20, 2020

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
First Episode Psychosis
Sponsor
Northwell Health
Enrollment
200
Locations
5
Primary Endpoint
Service Utilization Report Form
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2020
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Enrolled in a CSC program
  • Prescribed an oral antipsychotic

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Service Utilization Report Form

Time Frame: 12 months

Provides participant utilization of psychiatric ER visits or psychiatric hospitalization

Study Sites (5)

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