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Artificial Intelligence to Measure Adherence to Oral Medication

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Northwell Health

Status and phase

Enrolling
Phase 4

Conditions

First Episode Psychosis

Treatments

Other: Usual Care
Other: Smartphone App

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04046497
19-0307-ZHH

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

15 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Enrolled in a CSC program
  • Prescribed an oral antipsychotic

Exclusion criteria

  • none

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Smartphone App
Experimental group
Description:
artificial intelligence (AI) smartphone app to provide support for medication adherence
Treatment:
Other: Smartphone App
Usual Care
Active Comparator group
Description:
Usual care provided at CSC clinic
Treatment:
Other: Usual Care

Trial contacts and locations

5

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Central trial contact

Cristina Gonzalez, MS; Patricia Marcy, BSN

Data sourced from clinicaltrials.gov

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