Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397937
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
SDOH-Homecare Intervention Focus Team SHIFT Trial to Improve Stroke Outcomes
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The SDOH-Homecare Intervention Focus Team SHIFT Trial to Mitigate Structural Racism in Stroke Outcomes and Build Community Capacity The SHIFT Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
SHIFT
Brief Summary:
Primary Goal
To test the hypothesis that among AA and Hispanic stroke patients 18-75 years with 3 SDOH risk factors SHIFT will improve 1 functional outcomes as measured by the SIS Primary Outcome 2 physiological outcomes as measured by changes in blood pressure and cognition secondary outcomes and 3 epigenetic allostatic load biomarkers exploratory outcome such as DNA methylation DNAm and telomere length at 6 months and 1-year post-stroke compared with usual care UC
To test the hypothesis that among AA and Hispanic stroke patients 18-75 years with 3 SDOH risk factors SHIFT will improve 1 functional outcomes as measured by the SIS Primary Outcome 2 physiological outcomes as measured by changes in blood pressure and cognition secondary outcomes and 3 epigenetic allostatic load biomarkers exploratory outcome such as DNA methylation DNAm and telomere length at 6 months and 1-year post-stroke compared with usual care UC
Detailed Description:
Structural Racism and Discrimination SRD produces adverse Social Determinants of Health SDOH which have been shown increase stroke risk in a dose dependent manner The SDOH-Homecare Intervention Focus Team SHIFT trial is a Phase 3 randomized blinded outcome trial that tests the hypothesis that a homecare intervention shortly after discharge from an acute stroke unit by a team comprising a community health worker CHW a community social worker CSW and a community nurse CN can improve health outcomes among Black and Hispanic stroke patients compared with UC
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