Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761016
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-22
First Post:
2021-01-28
Brief Title:
The Integrated Population I-POP Health Trial
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
The Role of Community Health Workers to Reduce Health Disparities Using a Multi-Level Integrated Population Health Intervention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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:
I-POP
Brief Summary:
The primary aim of this study is to determine whether community health worker CHW navigation improves outcomes of chronic disease and chronic disease risk factors in a low-income primarily ethnic minority population when combined with an evidence-based population health model as compared to usual care after 10 months
Detailed Description:
The I-POPCHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes 75210 75215 75216 75217 75223 or 75227 Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes 1 Access to health services including oral health 2 Access to clinical prevention services 3 Access to education and facilities to increase physical activity and improved nutrition choices and 4 Scheduled visits with CHWs for education and navigation Individuals will complete study measures at baseline 6-months and 10-months
The control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months delayed CHW navigation The current usual care model is outlined below section 23 Participants will complete study measures at baseline 6-months and 10-months timepoints Upon completion of 10-months measures these individuals will be assigned a CHW and receive delayed navigation
The control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months delayed CHW navigation The current usual care model is outlined below section 23 Participants will complete study measures at baseline 6-months and 10-months timepoints Upon completion of 10-months measures these individuals will be assigned a CHW and receive delayed navigation
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