Artificial Intelligence to Measure Adherence to Oral Medication

NCT ID: NCT04046497

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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First Episode Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Smartphone App

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

Group Type EXPERIMENTAL

Smartphone App

Intervention Type OTHER

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

Usual Care

Usual care provided at CSC clinic

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual Care provided by CSC clinic

Interventions

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Smartphone App

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

Intervention Type OTHER

Usual Care

Usual Care provided by CSC clinic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Enrolled in a CSC program
* Prescribed an oral antipsychotic

Exclusion Criteria

* none
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Citrus Health

Hialeah, Florida, United States

Site Status RECRUITING

InterAct

Grand Rapids, Michigan, United States

Site Status RECRUITING

InterAct of Michigan

Kalamazoo, Michigan, United States

Site Status RECRUITING

Red Rock

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Family and Children's Services

Tulsa, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Marcy, BSN

Role: CONTACT

347-439-8035

Cristina Gonzalez, MS

Role: CONTACT

347-804-3605

Facility Contacts

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Jacob Gonzalez

Role: primary

Dana Schrader

Role: primary

Other Identifiers

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19-0307-ZHH

Identifier Type: -

Identifier Source: org_study_id

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