Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04497857
Status:
RECRUITING
Last Update Posted:
2023-05-18
First Post:
2020-07-31
Brief Title:
Academic-Community EPINET AC-EPINET
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Academic-Community EPINET AC-EPINET Mitigating Barriers to Care PILOT
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AC-EPINET
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01MH120588-02 | NIH | None | httpsreporternihgovquickSearch5R01MH120588-02 |