Virtual Group Visits for Type 2 Diabetes
(VIDA Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Chicago
Disqualifiers: Type 1 diabetes, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this 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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Virtual Group Visits for Type 2 Diabetes?
Research shows that virtual group visits for diabetes can help lower blood sugar levels, especially in patients with higher initial levels, and increase diabetes knowledge and support. These visits also reduce stress related to diabetes and empower patients to manage their condition better.
12345Is it safe to participate in virtual group visits for diabetes management?
The available research on virtual group visits for diabetes management does not report any specific safety concerns. These visits are generally considered safe, as they involve education and support rather than direct medical interventions.
12467How is the Virtual Group Visit treatment for type 2 diabetes different from other treatments?
Virtual Group Visits for type 2 diabetes are unique because they combine group education and individual medical consultations in a virtual setting, providing patients with social support and frequent contact with healthcare providers. This approach is different from traditional treatments as it leverages telehealth to improve patient engagement, diabetes knowledge, and emotional support, especially beneficial for those with limited access to in-person care.
248910Eligibility Criteria
This trial is for adults over 18 with type 2 diabetes and an A1C level above 8%, who also have a cardiovascular condition like high blood pressure, heart disease, or obesity. Participants must be from certain clinics, speak English or Spanish, and their primary care doctor must agree to their involvement.Inclusion Criteria
I visited a participating clinic in the last year.
Patient must have Type 2 diabetes
I am 18 years old or older.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff
6 months
6 visits (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
The study is testing the effectiveness of virtual group visits as a treatment method for patients with type 2 diabetes. It aims to see if these online meetings can help manage diabetes better than traditional methods.
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Group Visit ArmExperimental Treatment1 Intervention
These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.
Group II: Usual Care ArmActive Control1 Intervention
These subjects will receive usual diabetes care at ACCESS or Advocate health centers.
Virtual Group Visit is already approved in United States for the following indications:
🇺🇸 Approved in United States as Virtual Diabetes Group Visits for:
- Type 2 Diabetes Mellitus (T2DM)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Access Community Health NetworkChicago, IL
Advocate Health CareOrland Park, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
Wake Forest University Health SciencesCollaborator
ACCESS Community Health NetworkCollaborator
Advocate Health CareCollaborator
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
Midwest Clinicians' NetworkCollaborator
References
Virtual Group Appointments Reduce Distress and Improve Care Management in Young Adults with Type 1 Diabetes. [2022]The purpose of this study was to analyze the impact of virtual group appointments (VGA) on self-reported health-related outcomes and care activities for young adults (YA) with type 1 diabetes (T1D).
Evaluating Effects of Virtual Diabetes Group Visits in Community Health Centers During the COVID-19 Pandemic. [2023]Diabetes is the seventh leading cause of death in the US. Diabetes group visits (GVs), which include group education and individual medical visits have been shown to improve clinical outcomes. However, few studies have evaluated virtual GVs. We conducted a single-arm pilot study to test the impact of virtual diabetes GVs in Midwestern community health centers (CHCs). Adult patients with diabetes participated in monthly virtual GVs for 6 months. Surveys and chart abstraction were used to assess patient-reported and clinical outcomes. Five CHCs implemented virtual GVs with 34 patients attending at least one session. Virtual GVs show promise as evidenced by these findings: (1) Patients had a nonsignificant decrease in A1C. (2) In the subgroup of patients with baseline A1C ≥ 9%, there was a significant decrease in A1C. (3) Patients had significant increases in diabetes knowledge and support as well as a decrease in diabetes distress. Future studies with a larger sample size and a control comparison group are needed to assess the impact of virtual GVs on patient outcomes.
Shared medical appointments for patients with diabetes mellitus: a systematic review. [2022]Shared medical appointments (SMAs) are an increasingly used system-redesign strategy for improving access to and quality of chronic illness care. We conducted a systematic review of the existing literature on SMA interventions for patients with diabetes in order to understand their impact on outcomes.
Adapting in-person diabetes group visits to a virtual setting across federally qualified health centers. [2023]Diabetes group visits (GVs) have been shown to improve glycemic control, enrich patient self-care, and decrease healthcare utilization among patients with type 2 diabetes mellitus (T2DM). While telehealth has become routine, virtual GVs remain understudied, especially in federally qualified health centers (FQHCs). We conducted a 5-year cluster randomized trial with a waitlist control group to test the impact of diabetes GVs on patients' outcomes in Midwestern FQHCs. Due to COVID-19, the 6 waitlisted FQHCs adapted to virtual GVs. FQHC staff were provided training and support to implement virtual GVs. The GV intervention included 6 monthly 1-1.5-h long education sessions and appointments with a primary care provider. We measured staff perspectives and satisfaction via GV session logs, monthly webinars, and staff surveys and interviews. Adaptations for implementation of virtual GV included: additional staff training, video conferencing platform use, decreased session length and group size, and adjusting study materials, activities, and provider appointments. Sites enrolled a total of 48 adults with T2DM for virtual GVs. Most FQHCs were urban and all FQHCs predominantly had patients on public insurance. Patients attended 2.1 ± 2.2 GVs across sites on average. Thirty-four patients (71%) attended one or more virtual GVs. The average GV lasted 79.4 min. Barriers to virtual GVs included patient technology issues and access, patient recruitment and enrollment, and limited staff availability. Virtual GV facilitators included providing tablets, internet access from the clinic, and technical support. Staff reported spending on average 4.9 h/week planning and implementing GVs (SD = 5.9). On average, 6 staff from each FQHC participated in GV training and 1.2 staff reported past GV experience. All staff had worked at least 1 year at their FQHC and most reported multiple years of experience caring for patients with T2DM. Staff-perceived virtual GV benefits included: empowered patients to manage their diabetes, provided patients with social support and frequent contact with providers, improved relationships with patients, increased team collaboration, and better patient engagement and care-coordination. Future studies and health centers can incorporate these findings to implement virtual diabetes GVs and promote accessible diabetes care.
Shared medical appointments and patient-centered experience: a mixed-methods systematic review. [2020]Shared medical appointments (SMAs), or group visits, are a healthcare delivery method with the potential to improve chronic disease management and preventive care. In this review, we sought to better understand opportunities, barriers, and limitations to SMAs based on patient experience in the primary care context.
Virtual Group Visits: Hope for Improving Chronic Disease Management in Primary Care During and After the COVID-19 Pandemic. [2021]As health care systems respond to the COVID-19 pandemic, new virtual care approaches are emerging for health promotion and chronic disease management. Virtual group visits (VGVs) supporting a healthy lifestyle, adapted from the well-established shared medical appointment (SMA) model, hold promise as a primary care delivery tool for preventing and managing chronic disease. In order to establish VGVs as standard of care, evidence for clinical effectiveness, financial sustainability, and access for vulnerable populations is needed. In the future, VGVs could improve the quality and reach of chronic disease prevention and management strategies.
Diabetes group medical visits and outcomes of care in low-income, rural, uninsured persons. [2020]The purpose of this study was to test the effectiveness of Diabetes Group Medical Visits (DGMVs) verses usual care in a sample of low-income patients with diabetes receiving care at a rural free clinic.
Assessing the effectiveness of a diabetes group visit training for health center staff: a pilot study of five Midwestern community health centers. [2022]Diabetes group visits are shared appointments that include diabetes education in a group setting and individual visits with a medical provider. An 18-month pilot study was designed to evaluate organizational capacity and staff preparedness in implementing and sustaining diabetes group visits.
Evaluation of an Ongoing Diabetes Group Medical Visit in a Family Medicine Practice. [2022]Group medical visits (GMVs), which combine 1-on-1 clinical consultations and group self-management education, have emerged as a promising vehicle for supporting type 2 diabetes management in primary care. However, few evaluations exist of ongoing diabetes GMVs embedded in medical practices.
Group visits: promoting adherence to diabetes guidelines. [2022]Current diabetes management guidelines offer blueprints for providers, yet type 2 diabetes control is often poor in disadvantaged populations. The group visit is a new treatment modality originating in managed care for efficient service delivery to patients with chronic health problems. Group visits offer promise for delivering care to diabetic patients, as visits are lengthier and can be more frequent, more organized, and more educational.