NCT04248517

Brief Summary

This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote shared decision making (SDM) and personalized interventions. The result will be a time-sensitive, data-driven, collaborative process to optimize medication regimens in order to maximize benefits, minimize harms, and promote adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

4 active sites

Status
completed

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

January 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 9, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

January 22, 2020

Last Update Submit

April 29, 2024

Conditions

SchizophreniaFirst-Episode Psychosis

Keywords

mHealthSchizophreniaEMA

Outcome Measures

Primary Outcomes (2)

  • change of Treatment Satisfaction Questionnaire for Medication (TQSM) from baseline to 6 months

    The TSQM assesses client satisfaction with medication. It comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the patient's last use. With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied).The 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow for precise information to be obtained at the upper end of the score distribution. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items.

    baseline to 6 months

  • change of Client Satisfaction Questionnaire (CSQ-8) from baseline to 6 months

    8-item easily scored and administered measurement that is designed to measure client satisfaction with services. The overall score is produced by summing all item responses. Scores range from 8 to 32, with higher values indicating higher satisfaction.

    baseline to 6 months

Study Arms (2)

mHealth intervention group

EXPERIMENTAL

participants in the mHealth Group will download the app on to their smartphone and complete ecological momentary assessments on 3 consecutive weekdays every 2 weeks for 6 months.

Other: mHealth Intervention

Treatment as Usual group

NO INTERVENTION

participants will undergo their routine treatment.

Interventions

mHealth InterventionOTHER

Participants will download the app onto their smartphone and complete ecological momentary assessements

mHealth intervention group

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female OnTrackNY participants, ages 16 to 30, of any race/ethnicity
  • Able and willing to give informed consent and participate in the intervention
  • Participating in OnTrackNY for less than 1 year because this group may be more in need of medication adjustments and will be less likely to graduate from the program before 6 months of participation.

You may not qualify if:

  • Suicidal at baseline with C-SSRS score 4 or 5.
  • PANSS baseline score of 5 (moderately severe) or greater on the Conceptual Disorganization item (P2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bestself Behavioral Health, Inc.

Buffalo, New York, 14202, United States

Location

Washington Heights Community Service

New York, New York, 10032, United States

Location

Lenox Hill Hospital

New York, New York, 10065, United States

Location

Institute for Family Health

New York, New York, 10453, United States

Location

Related Publications (1)

  • Stefancic A, Rogers RT, Styke S, Xu X, Buchsbaum R, Nossel I, Cabassa LJ, Stroup TS, Kimhy D. Development of the First Episode Digital Monitoring mHealth Intervention for People With Early Psychosis: Qualitative Interview Study With Clinicians. JMIR Ment Health. 2022 Nov 4;9(11):e41482. doi: 10.2196/41482.

    PMID: 36331539DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Scott Stroup, MD, MPH

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective cohort with comparison group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 30, 2020

Study Start

October 9, 2020

Primary Completion

December 31, 2022

Study Completion

January 20, 2023

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Raw data will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories including the National Database for Clinical Trials related to Mental Illness (NDCT). Data will include baseline demographic data, and baseline and post raw data derived from functioning and symptom measures.

Shared Documents
STUDY PROTOCOL
Time Frame
A list of all data expected to be collected in the project will be submitted within 6 months of award. Subsequently, descriptive and raw data will be submitted on a semi-annual basis. Unpublished de-identified data will be submitted prior to study completion and will be shared within one year after project completion, or when the data are published, whichever is earlier.
Access Criteria
Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.

Locations

US(4)