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Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs

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ClinicalTrials.gov Identifier: NCT04005378
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : April 16, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.

Condition or disease Intervention/treatment Phase
First Episode Psychosis Other: CSC Step-down intervention Other: Usual Care Phase 4

Detailed Description:
In Phase 1 of the project, we will confirm a model predicting factors associated with later disengagement from CSC treatment. In Phase 2, we will compare disengagement among high-risk individuals with a CSC Step-down intervention to that with standard CSC care. The Step-down intervention will use web-based telemedicine and a smartphone app, to decrease disengagement likelihood. High-risk participants identified by predictors found in Phase 1 will be offered the intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Step wedge cluster design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
CSC Step-down intervention
Web-based telemedicine and a smartphone app, to decrease disengagement likelihood
Other: CSC Step-down intervention
Web-based telemedicine and a smartphone app, to decrease disengagement likelihood

Usual Care
Usual care provided by CSC center
Other: Usual Care
Usual Care provided by CSC center




Primary Outcome Measures :
  1. Disengagement rate [ Time Frame: Minimum of 6 months ]
    Rate of disengagement from CSC program



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled into a CSC program

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005378


Contacts
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Contact: Patricia Marcy, BSN 347-439-8035 pmarcy@northwell.edu
Contact: Cristina Gonzalez, MS 347-804-3605

Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04005378    
Other Study ID Numbers: 19-0307 -B
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders