Actively Recruiting

Phase 4
Age: 15Years - 40Years
All Genders
ID04046497

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

Led by Northwell Health · Updated on 2024-09-19

200

Participants Needed

5

Research Sites

4 weeks

Total Duration

On this page

Sponsors

N

Northwell Health

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a smartphone app that uses artificial intelligence (AI) to support medication adherence in people experiencing their first episode of psychosis. The study aims to see how acceptable the app is to patients and to compare hospitalization and emergency room visit rates between those using the app and those receiving standard care. This research addresses the significant challenge of monitoring and improving oral medication adherence in this population, which is linked to better clinical outcomes. Participants are randomly assigned to one of two groups: one group uses the AI smartphone app designed to help with oral medication adherence, while the other group receives usual care provided by the Coordinated Specialty Care (CSC) clinic. The app offers a novel way to support and monitor medication adherence that is more feasible in community settings than traditional methods like direct observation. During the study, researchers will track participants' healthcare service usage over 12 months, focusing on hospitalizations and emergency visits. Participants' acceptability of the AI app will also be assessed based on their engagement in the study. The study runs from November 2020 through December 2024 and involves adults aged 15 to 40 years diagnosed with first episode psychosis. This includes monitoring through service utilization reports and comparisons of outcomes between the two groups.

CONDITIONS

Brief Title

Artificial Intelligence to Measure Adherence to Oral Medication

Who Can Participate

Age: 15Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Enrolled in a Coordinated Specialty Care (CSC) program
  • Prescribed an oral antipsychotic
  • Aged between 15 and 40 years
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 months

Participants use either the artificial intelligence smartphone app to support medication adherence or receive usual care provided at the Coordinated Specialty Care clinic.

Trial Site Locations

Total: 5 locations

1

Citrus Health

Hialeah, Florida, United States, 33012

Actively Recruiting

2

InterAct

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

3

InterAct of Michigan

Kalamazoo, Michigan, United States, 49007

Actively Recruiting

4

Red Rock

Oklahoma City, Oklahoma, United States, 73105

Actively Recruiting

5

Family and Children's Services

Tulsa, Oklahoma, United States, 74315

Actively Recruiting

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Research Team

P

Patricia Marcy, BSN

C

Cristina Gonzalez, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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