Artificial Intelligence to Measure Adherence to Oral Medication

Phase 4

Recruiting

• Conditions: First Episode Psychosis
• Interventions: Other: Usual Care; Other: Smartphone App

• Registration Number: NCT04046497
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Study Start: 2020-11-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Enrolled in a CSC program
• Prescribed an oral antipsychotic

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Usual care provided at CSC clinic
Smartphone App	Smartphone App	artificial intelligence (AI) smartphone app to provide support for medication adherence

Primary Outcome Measures

Name	Time	Method
Service Utilization Report Form	12 months	Provides participant utilization of psychiatric ER visits or psychiatric hospitalization

Trial Locations

Locations (5)

Citrus Health; 🇺🇸 Hialeah, Florida, United States

InterAct of Michigan; 🇺🇸 Kalamazoo, Michigan, United States

InterAct; 🇺🇸 Grand Rapids, Michigan, United States

Red Rock; 🇺🇸 Oklahoma City, Oklahoma, United States

Family and Children's Services; 🇺🇸 Tulsa, Oklahoma, United States