Online Diabetes Education Project (ODEP)

University of Michigan

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Virtual Diabetes Self-Management Education and Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04743778

ODEP HUM00190508

P30DK092926 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Virtual Diabetes Self-Management Education and Support

Experimental group

Description:

Participants 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.

Treatment:

Behavioral: Virtual Diabetes Self-Management Education and Support