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Clinical Trial Summary

The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.


Clinical Trial Description

180 subjects will be randomized into a 12 month study, to one of two treatment arms. The investigators will assess four important elements of engagement to determine which are most sensitive to TH treatment and mediates effects on hospitalization rates. The investigators will assess acceptability and satisfaction of CSC-TH compared to CSC-SD, and deliver a training manual for implementing TH in CSC clinics and for use in future research. Although this study has exploratory aims consistent with pilot projects, The investigators have incorporated methodological rigor where possible (randomization, powering for hospitalization rate) in order to achieve the most robust data to assess the main study questions and inform future trials. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04497857
Study type Interventional
Source Indiana University
Contact Research Manager
Phone 3178808438
Email iupdp@iupui.edu
Status Recruiting
Phase N/A
Start date March 16, 2022
Completion date August 31, 2024

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