NCT04046497

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2020

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

July 1, 2019

Last Update Submit

September 10, 2024

Conditions

First Episode Psychosis

Outcome Measures

Primary Outcomes (1)

  • Service Utilization Report Form

    Provides participant utilization of psychiatric ER visits or psychiatric hospitalization

    12 months

Study Arms (2)

Smartphone App

EXPERIMENTAL

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

Other: Smartphone App

Usual Care

ACTIVE COMPARATOR

Usual care provided at CSC clinic

Other: Usual Care

Interventions

Smartphone AppOTHER

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

Smartphone App
Usual CareOTHER

Usual Care provided by CSC clinic

Usual Care

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in a CSC program
  • Prescribed an oral antipsychotic

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Citrus Health

Hialeah, Florida, 33012, United States

RECRUITING

InterAct

Grand Rapids, Michigan, 49503, United States

RECRUITING

InterAct of Michigan

Kalamazoo, Michigan, 49007, United States

RECRUITING

Red Rock

Oklahoma City, Oklahoma, 73105, United States

RECRUITING

Family and Children's Services

Tulsa, Oklahoma, 74315, United States

RECRUITING

Central Study Contacts

Patricia Marcy, BSN

CONTACT

347-439-8035pmarcy@northwell.edu

Cristina Gonzalez, MS

CONTACT

347-804-3605

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

August 6, 2019

Study Start

November 20, 2020

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(5)