Online Diabetes Education Project (ODEP)

Study Overview
=================
Brief Summary
-----------------
This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants will be randomized to either a control group or the virtual DSME/S group.

Detailed Description
-----------------
This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants interested in participating in this study will first be consented then they will complete a baseline health assessment including a questionnaire and physiologic testing. Using a 50/50 randomization scheme, participants will be randomized to either a control group or the virtual DSME/S group and be told of their placement. Participants randomized to the control group will receive community resources, diabetes specific newsletters, and pedometers. Participants randomized to the virtual DSME/S group will receive 10-weekly 1-hour virtual DSME/S sessions with a certified diabetes care and education specialists through Zoom for Health at the University of Michigan, a HIPPA compliant platform. After the intervention is complete and then again 3 months later, participants in both groups will be invited to complete an additional health assessment.

Official Title
-----------------
Online Diabetes Education Project: Virtual Diabetes Self-Management Education and Support Intervention

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Virtual Diabetes Self-Management Education and Support
* Behavioral: Resources


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agee 18 or older, Black, a diagnosis of T2D for one year duration or longer, ambulatory status. Exclusion Criteria: Non-ambulatory, serious health conditions (morbid obesity and severe symptomatic heart disease, visual impairment, renal failure, and peripheral neuropathy), psychiatric illness (severity requiring hospitalization) or cognitive deficit (illness determined using the Montreal Cognitive Assessment tool) and serious diabetes complications (e.g. blindness) that would impede meaningful participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Diabetes Self-Management Education and Support<br>Participants randomized into the virtual empowerment-based DSME/S group will receive one hour of DSME/S delivered by a Certified Diabetes Care and Education Specialist (CDCES) per week for 10 weeks delivered via the Zoom for Health at U-M service may be used for Protected Health Information (PHI, regulated by HIPAA). To ensure treatment fidelity, three DSME/S sessions will be selected at random and recorded and rated for fidelity to the above content by our research team. | Behavioral: Virtual Diabetes Self-Management Education and Support<br>* Diabetes self-management education and support delivered through Zoom for health.<br>|
| Active Comparator: Control Group<br>Participants randomized to enhanced usual care will receive referrals to community mental health providers, pedometers, gym memberships to a community-based venue, and intervention patient manuals. Based on several years of experience in Detroit, providing all participants with referrals, pedometers, and educational materials minimizes ethical concerns regarding assignment of underserved populations to receive a no-treatment control. | Behavioral: Resources<br>* Newsletters, pedometers, and community resources.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control of A1c | Measured using the DCA 2000 point-of-care testing instrument | 6 months | 
| Depression | Measured using the PHQ-9 (score >=10) and the BDI-II | 6 months | 
| Regimen adherence | Measured using the Perceived Diabetes Self-Management Scale, a self-report questionnaire used to measure a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Calculated using height and weight. Height will be measured using a stadiometer. Weight will be measured on a high quality, calibrated digital scale. | 6 months | 
| Blood pressure | Measured using the auscultatory method. | 6 months | 
| Diabetes Social Support | Measured using the Diabetes Social Support Questionnaire | 6 months | 
| Diabetes-related Distress | Measured using the Diabetes Distress Scale (SF-12) | 6 months | 
| Diabetes Quality of Life | Measured using the Diabetes Quality of Life Questionnaire | 6 months |