Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
720 participants
INTERVENTIONAL
2024-05-03
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Virtual Group Visit Arm
These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.
Virtual Group Visit
Group visits must have these core components: diabetes education, group social support and goal setting.
Usual Care Arm
These subjects will receive usual diabetes care at ACCESS or Advocate health centers.
No interventions assigned to this group
Interventions
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Virtual Group Visit
Group visits must have these core components: diabetes education, group social support and goal setting.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
ACCESS Community Health Network
OTHER
Midwest Clinicians' Network
UNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Arshiya Baig, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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Access Community Health Network
Chicago, Illinois, United States
Advocate Health Care
Orland Park, Illinois, United States
Countries
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Other Identifiers
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IRB23-0325
Identifier Type: -
Identifier Source: org_study_id
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