Virtual Diabetes Group Visits Across Health Systems (VIDA)

April 24, 2024 updated by: University of Chicago

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 underserved and low-income patients each year, including over 25,000 patients with diabetes and 30,000 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 117,000 patients, of which 27% identify as African American/Black and 15% identify as Hispanic/Latino. 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 Type

Interventional

Enrollment (Estimated)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Group Visit Arm
These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.
Behavioral: Virtual Group Visit
Group visits must have these core components: diabetes education, group social support and goal setting.
No Intervention: Usual Care Arm
These subjects will receive usual diabetes care at ACCESS or Advocate health centers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A1c
Time Frame: 12 months
This is blood test that measures the percent of glucose and hemoglobin bound together.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 12 months
Systolic blood pressure measures the arterial pressure
12 months
Body Mass Index
Time Frame: 12 months
Measure of body fat based on height and weight
12 months
Low density lipoproteins
Time Frame: 12 months
a measure of cholesterol in the blood
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Advocate Health Care
ACCESS Community Health Network
Midwest Clinicians' Network

Investigators

  • Principal Investigator: Arshiya Baig, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 3, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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