Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094491
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-10-17
Brief Title:
Virtual Diabetes Group Visits Across Health Systems
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
VIDA Virtual Diabetes Group Visits Across Health Systems Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
VIDA
Brief Summary:
The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus T2DM
Detailed Description:
Managing diabetes can be complex and burdensome patients must modify their diet take medications check their blood sugar and visit their healthcare providers regularly Diabetes group visits GVs-virtual group education and diabetes support including goal setting-create a unique setting where patients can connect with peers and receive medical care and support GVs can improve glycemic control and decrease healthcare utilization GVs can provide patients with comprehensive care for their multimorbid chronic condition
Virtual GVs provide an opportunity to adapt to the current trends of telehealth and the ability to increase reach and scalability across multiple sites Before the model can be widely adopted important questions about the effectiveness and implementation of the virtual diabetes GV model need to be addressed The investigators propose to build on an established program of diabetes GVs This proposal aims to implement the virtual GV model VIDA Virtual Diabetes Group Visits Across Health Systems in two distinct health systems in the Chicago region Access Community Health Network ACCESS is one of the largest federally qualified health centers FQHCs in the United States with 35 sites across the Chicago metropolitan area providing care for 175000 medically underserved and low-income patients each year including over 25000 patients with diabetes and 30000 patients who are uninsured 60 of ACCESS patients are Hispanic and 30 are African-American Advocate Health Care ADVOCATE is a large diverse integrated private not-for-profit health system that includes 26 hospitals and more than 500 ambulatory sites The system provides care across more than 129 primary care clinics in Illinois serving over 117000 patients of which 27 identify as African AmericanBlack and 15 identify as HispanicLatino Both are community-based health systems serving low-income and communities of color in Chicago and are network partners of the Chicago Chronic Condition Equity Network C3EN
No studies have systematically implemented virtual diabetes GVs for adults with T2DM in the real-world primary care setting or across distinct health systems The ability to train implement and evaluate virtual GVs across systems with different care models provides the opportunity to learn about adaptation and the barriers and facilitators for implementation This proposed study will compare virtual diabetes GVs to usual care using a type I hybrid effectiveness-implementation design via a pragmatic cluster randomized trial
Virtual GVs provide an opportunity to adapt to the current trends of telehealth and the ability to increase reach and scalability across multiple sites Before the model can be widely adopted important questions about the effectiveness and implementation of the virtual diabetes GV model need to be addressed The investigators propose to build on an established program of diabetes GVs This proposal aims to implement the virtual GV model VIDA Virtual Diabetes Group Visits Across Health Systems in two distinct health systems in the Chicago region Access Community Health Network ACCESS is one of the largest federally qualified health centers FQHCs in the United States with 35 sites across the Chicago metropolitan area providing care for 175000 medically underserved and low-income patients each year including over 25000 patients with diabetes and 30000 patients who are uninsured 60 of ACCESS patients are Hispanic and 30 are African-American Advocate Health Care ADVOCATE is a large diverse integrated private not-for-profit health system that includes 26 hospitals and more than 500 ambulatory sites The system provides care across more than 129 primary care clinics in Illinois serving over 117000 patients of which 27 identify as African AmericanBlack and 15 identify as HispanicLatino Both are community-based health systems serving low-income and communities of color in Chicago and are network partners of the Chicago Chronic Condition Equity Network C3EN
No studies have systematically implemented virtual diabetes GVs for adults with T2DM in the real-world primary care setting or across distinct health systems The ability to train implement and evaluate virtual GVs across systems with different care models provides the opportunity to learn about adaptation and the barriers and facilitators for implementation This proposed study will compare virtual diabetes GVs to usual care using a type I hybrid effectiveness-implementation design via a pragmatic cluster randomized trial
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 |
|---|---|---|---|
| P50MD017349 | NIH | None | httpsreporternihgovquickSearchP50MD017349 |