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Artificial Intelligence

AI-Powered Medication Adherence App for First Episode Psychosis

Phase 4
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prescribed an oral antipsychotic
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial aims to test whether an AI smartphone app can help patients with first episode psychosis stick to their medication regimen.

Who is the study for?
This trial is for individuals enrolled in a Coordinated Specialty Care (CSC) program who have been prescribed an oral antipsychotic medication to manage conditions like psychosis or first episode psychosis. There are no specific exclusion criteria, so it's open to anyone meeting the inclusion requirements.Check my eligibility
What is being tested?
The study is testing an artificial intelligence-powered smartphone app designed to help patients with their adherence to taking oral antipsychotic medications regularly as compared to the usual care without such technological support.See study design
What are the potential side effects?
Since this trial involves using a smartphone app rather than a drug, there aren't typical medical side effects. However, participants may experience issues related to privacy, data security, or stress from technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am taking an oral antipsychotic medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Service Utilization Report Form

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Smartphone AppExperimental Treatment1 Intervention
artificial intelligence (AI) smartphone app to provide support for medication adherence
Group II: Usual CareActive Control1 Intervention
Usual care provided at CSC clinic

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,790 Previous Clinical Trials
2,691,279 Total Patients Enrolled
Northwell HealthLead Sponsor
460 Previous Clinical Trials
470,843 Total Patients Enrolled

Media Library

Smartphone App (Artificial Intelligence) Clinical Trial Eligibility Overview. Trial Name: NCT04046497 — Phase 4
First Episode Psychosis Research Study Groups: Smartphone App, Usual Care
First Episode Psychosis Clinical Trial 2023: Smartphone App Highlights & Side Effects. Trial Name: NCT04046497 — Phase 4
Smartphone App (Artificial Intelligence) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04046497 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum participant capacity for this experiment?

"Affirmative. According to clinicaltrials.gov, this research study is enrolling participants as of January 3rd 2022, with the initial posting dating back to November 20th 2020. It has been determined that two sites will be needed for recruiting a total of 200 individuals."

Answered by AI

Has the US Food and Drug Administration cleared this mobile application for use?

"With data backing the efficacy and safety of this Smartphone App, it earned a score of 3 on our team's rating system. This is due to its Phase 4 status, meaning that approval has already been granted."

Answered by AI

Are there any open slots remaining in this research trial?

"Affirmative. Data stored on clinicaltrials.gov stipulates that this medical study, first launched in November 2020, is currently seeking participants. 200 individuals are needed from two different sites for the trial to be successful."

Answered by AI

What criteria must individuals fulfill to be eligible for participation in this trial?

"This clinical trial seeks to enrol 200 individuals afflicted with psychotic disorders aged between 15 and 40."

Answered by AI

Is enrollment open to adults aged 18 and above for this experiment?

"The appropriate age range for enrollees in this medical study is 15 to 40. Additionally, 68 studies are available for youth and 97 trials exist for the elderly population."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
How old are they?
18 - 65
What site did they apply to?
InterAct of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
~17 spots leftby Oct 2024