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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04046497
Enrollment
200
Registered
2019-08-06
Start date
2020-11-20
Completion date
2024-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Episode Psychosis

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.

Interventions

OTHERSmartphone App

artificial intelligence (AI) smartphone app to provide support for medication adherence

OTHERUsual Care

Usual Care provided by CSC clinic

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Northwell Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Enrolled in a CSC program * Prescribed an oral antipsychotic

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Service Utilization Report Form12 monthsProvides participant utilization of psychiatric ER visits or psychiatric hospitalization

Countries

United States

Contacts

Primary ContactPatricia Marcy, BSN
pmarcy@northwell.edu347-439-8035
Backup ContactCristina Gonzalez, MS
347-804-3605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026