Artificial Intelligence to Measure Adherence to Oral Medication

First Episode Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04046497
• Other study ID #: 19-0307-ZHH
• Status: Recruiting
• Phase: Phase 4
• Start date: November 20, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Northwell Health
• Contact: Patricia Marcy, BSN
• Phone: 347-439-8035
• Email: pmarcy[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• Enrolled in a CSC program

• Prescribed an oral antipsychotic

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• First Episode Psychosis
• Psychotic Disorders

Intervention

Other:
• Smartphone App
artificial intelligence (AI) smartphone app to provide support for medication adherence
• Usual Care
Usual Care provided by CSC clinic

Locations

Country	Name	City	State
United States	InterAct	Grand Rapids	Michigan
United States	Citrus Health	Hialeah	Florida
United States	InterAct of Michigan	Kalamazoo	Michigan
United States	Red Rock	Oklahoma City	Oklahoma
United States	Family and Children's Services	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Service Utilization Report Form	Provides participant utilization of psychiatric ER visits or psychiatric hospitalization	12 months