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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

Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date April 16, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date April 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Disengagement rate [ Time Frame: Minimum of 6 months ]
Rate of disengagement from CSC program
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
Official Title  ICMJE Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Step wedge cluster design
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE First Episode Psychosis
Intervention  ICMJE
  • Other: CSC Step-down intervention
    Web-based telemedicine and a smartphone app, to decrease disengagement likelihood
  • Other: Usual Care
    Usual Care provided by CSC center
Study Arms  ICMJE
  • CSC Step-down intervention
    Web-based telemedicine and a smartphone app, to decrease disengagement likelihood
    Intervention: Other: CSC Step-down intervention
  • Usual Care
    Usual care provided by CSC center
    Intervention: Other: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2024
Estimated Primary Completion Date April 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Enrolled into a CSC program

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Patricia Marcy, BSN 347-439-8035 pmarcy@northwell.edu
Contact: Cristina Gonzalez, MS 347-804-3605
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005378
Other Study ID Numbers  ICMJE 19-0307 -B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account Northwell Health
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP