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Virtual Diabetes Group Visits Across Health Systems (VIDA)

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The University of Chicago

Status and phase

Active, not recruiting
Phase 2

Conditions

Hypertension
Hyperlipidemias
Stroke
Peripheral Vascular Diseases
Obesity
T2DM (Type 2 Diabetes Mellitus)
Heart Disease Chronic

Treatments

Behavioral: Virtual Group Visit

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06094491
P50MD017349-04 (U.S. NIH Grant/Contract)
IRB23-0325

Details and patient eligibility

About

The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus (T2DM).

Full 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.

Enrollment

720 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

720 participants in 2 patient groups

Virtual Group Visit Arm
Experimental group
Description:
These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.
Treatment:
Behavioral: Virtual Group Visit
Usual Care Arm
No Intervention group
Description:
These subjects will receive usual diabetes care at ACCESS or Advocate health centers.

Trial contacts and locations

2

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Central trial contact

Melanie Norstrom; Arshiya Baig, MD

Data sourced from clinicaltrials.gov

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