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Virtual Diabetes Group Visits Across Health Systems (VIDA)

Primary Purpose

T2DM (Type 2 Diabetes Mellitus), Hypertension, Heart Disease Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Group Visit
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for T2DM (Type 2 Diabetes Mellitus) focused on measuring virtual group visits

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Virtual Group Visit Arm

    Usual Care Arm

    Arm Description

    These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.

    These subjects will receive usual diabetes care at ACCESS or Advocate health centers.

    Outcomes

    Primary Outcome Measures

    A1c
    This is blood test that measures the percent of glucose and hemoglobin bound together.

    Secondary Outcome Measures

    Systolic blood pressure
    Systolic blood pressure measures the arterial pressure
    Body Mass Index
    Measure of body fat based on height and weight
    Low density lipoproteins
    a measure of cholesterol in the blood

    Full Information

    First Posted
    October 17, 2023
    Last Updated
    October 17, 2023
    Sponsor
    University of Chicago
    Collaborators
    Advocate Health Care, ACCESS Community Health Network, National Institute on Minority Health and Health Disparities (NIMHD), Midwest Clinicians' Network
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06094491
    Brief Title
    Virtual Diabetes Group Visits Across Health Systems
    Acronym
    VIDA
    Official Title
    VIDA: Virtual Diabetes Group Visits Across Health Systems: Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    May 2026 (Anticipated)
    Study Completion Date
    May 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Chicago
    Collaborators
    Advocate Health Care, ACCESS Community Health Network, National Institute on Minority Health and Health Disparities (NIMHD), Midwest Clinicians' Network

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    T2DM (Type 2 Diabetes Mellitus), Hypertension, Heart Disease Chronic, Stroke, Hyperlipidemias, Peripheral Vascular Diseases, Obesity
    Keywords
    virtual group visits

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Type I hybrid effectiveness-implementation cluster randomized trial among adult patients with T2DM across 9 intervention sites and 9 control sites
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    720 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual Group Visit Arm
    Arm Type
    Experimental
    Arm Description
    These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.
    Arm Title
    Usual Care Arm
    Arm Type
    No Intervention
    Arm Description
    These subjects will receive usual diabetes care at ACCESS or Advocate health centers.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual Group Visit
    Intervention Description
    Group visits must have these core components: diabetes education, group social support and goal setting.
    Primary Outcome Measure Information:
    Title
    A1c
    Description
    This is blood test that measures the percent of glucose and hemoglobin bound together.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure measures the arterial pressure
    Time Frame
    12 months
    Title
    Body Mass Index
    Description
    Measure of body fat based on height and weight
    Time Frame
    12 months
    Title
    Low density lipoproteins
    Description
    a measure of cholesterol in the blood
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Melanie Norstrom
    Phone
    (773) 702-3962
    Email
    mnorstrom@medicine.bsd.uchicago.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arshiya Baig, MD
    Phone
    773-834-4760
    Email
    abaig@medicine.bsd.uchicago.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arshiya Baig, MD
    Organizational Affiliation
    University of Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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