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NCT Number: NCT04046497

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.

Recruiting

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Citrus Health, Hialeah, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in a CSC program
  • Prescribed an oral antipsychotic

Exclusion criteria

  • none

Treatment and study plan

Smartphone app

Other

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

Usual Care

Other

Usual Care provided by CSC clinic

Primary outcomes

  1. Service Utilization Report Form

    Time frame: 12 months

    Provides participant utilization of psychiatric ER visits or psychiatric hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Gonzalez, MS

CONTACT

347-804-3605

Patricia Marcy, BSN

CONTACT

[email protected]

347-439-8035

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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