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Recruiting NCT04046497

Artificial Intelligence to Measure Adherence to Oral Medication

Phase IV Interventional First Episode Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartphone App, Usual Care.
Who it may be relevant to
Registry conditions: First Episode Psychosis. Basic parameters: 15 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • Service Utilization Report Form [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Enrolled in a CSC program
  • Prescribed an oral antipsychotic

Exclusion criteria

  • none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 5 centers
  • Citrus Health — Hialeah
  • InterAct — Grand Rapids
  • InterAct of Michigan — Kalamazoo
  • Red Rock — Oklahoma City
  • Family and Children's Services — Tulsa

Identifiers

NCT: NCT04046497 · 19-0307-ZHH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗