Clinical trial NCT04743778: Online Diabetes Education Project (ODEP)
Official title: Online Diabetes Education Project: Virtual Diabetes Self-Management Education and Support Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-02-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Initially, we intended to have a control group and an intervention group. However, due to low recruitment numbers and COVID-19 pandemic barriers, we decided to offer all participants virtual DSME/S.
Primary purpose: TREATMENT

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.

However, due to low recruitment we removed the control arm and offered all participants virtual DSME/S.

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

Primary outcomes:
measure: Metabolic Control of A1c (Mean Change in A1C)
timeFrame: baseline and at 3 months
measure: Depression
timeFrame: baseline and at 3 months
measure: Regimen Adherence
timeFrame: baseline and at 3 months
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: baseline 3 months
measure: Blood Pressure
timeFrame: baseline and at 3 months
measure: Diabetes Social Support
timeFrame: baseline and at 3 months
measure: Diabetes-Related Distress
timeFrame: baseline and at 3 months
measure: Diabetes Quality of Life
timeFrame: baseline and at 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan, School of Social Work
name: Jaclynn Hawkins, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
References: