Artificial Intelligence to Measure Adherence to Oral Medication
Primary Purpose
First Episode Psychosis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Smartphone App
Usual Care
Sponsored by
About this trial
This is an interventional other trial for First Episode Psychosis
Eligibility Criteria
Inclusion Criteria:
- Enrolled in a CSC program
- Prescribed an oral antipsychotic
Exclusion Criteria:
- none
Sites / Locations
- Citrus HealthRecruiting
- InterActRecruiting
- InterAct of MichiganRecruiting
- Red RockRecruiting
- Family and Children's ServicesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smartphone App
Usual Care
Arm Description
artificial intelligence (AI) smartphone app to provide support for medication adherence
Usual care provided at CSC clinic
Outcomes
Primary Outcome Measures
Service Utilization Report Form
Provides participant utilization of psychiatric ER visits or psychiatric hospitalization
Secondary Outcome Measures
Full Information
NCT ID
NCT04046497
First Posted
July 1, 2019
Last Updated
May 24, 2023
Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04046497
Brief Title
Artificial Intelligence to Measure Adherence to Oral Medication
Official Title
Early-phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO) - Using Artificial Intelligence to Measure Adherence to Oral Medication
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Psychosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Smartphone App
Arm Type
Experimental
Arm Description
artificial intelligence (AI) smartphone app to provide support for medication adherence
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care provided at CSC clinic
Intervention Type
Other
Intervention Name(s)
Smartphone App
Intervention Description
artificial intelligence (AI) smartphone app to provide support for medication adherence
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care provided by CSC clinic
Primary Outcome Measure Information:
Title
Service Utilization Report Form
Description
Provides participant utilization of psychiatric ER visits or psychiatric hospitalization
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in a CSC program
Prescribed an oral antipsychotic
Exclusion Criteria:
none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Marcy, BSN
Phone
347-439-8035
Email
pmarcy@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Gonzalez, MS
Phone
347-804-3605
Facility Information:
Facility Name
Citrus Health
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
InterAct
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Gonzalez
Facility Name
InterAct of Michigan
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Schrader
Facility Name
Red Rock
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73105
Country
United States
Individual Site Status
Recruiting
Facility Name
Family and Children's Services
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74315
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Artificial Intelligence to Measure Adherence to Oral Medication
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