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Clinical Trials/NCT06094491
NCT06094491
Active, not recruiting
Phase 2

VIDA: Virtual Diabetes Group Visits Across Health Systems: Randomized Control Trial

University of Chicago2 sites in 1 country720 target enrollmentMay 3, 2024

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
T2DM (Type 2 Diabetes Mellitus)
Sponsor
University of Chicago
Enrollment
720
Locations
2
Primary Endpoint
A1c
Status
Active, not recruiting
Last Updated
6 months ago

Overview

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 175,000 medically under-resourced and low-income patients each year. Advocate Health Care (ADVOCATE) is a large, 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 117,000 patients. Both are community-based health systems serving low-income communities in Chicago and are network partners of the Chicago Chronic Conditions Engagement 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 obstacles 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.

Registry
clinicaltrials.gov
Start Date
May 3, 2024
End Date
June 30, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient at a PARTICIPATING clinic (at least one visit in year prior to first GV)
  • Type 2 diabetes
  • ≥ 18 years old
  • A1C\>8% within 6 months prior to first GV (we will first recruit patients with A1C\>9%, then if spaces still available A1C\>8.5%, then if spaces still available A1C\>8%)
  • At least one additional cardiovascular condition (hypertension, heart disease, stroke, hyperlipidemia, peripheral vascular disease, or BMI ≥ 30)
  • English or Spanish speaking
  • PCP assented to recruiting patient
  • Patient provides written consent

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

A1c

Time Frame: 12 months

This is blood test that measures the percent of glucose and hemoglobin bound together.

Secondary Outcomes

  • Low density lipoproteins(12 months)
  • Systolic blood pressure(12 months)
  • Body Mass Index(12 months)

Study Sites (2)

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