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

University of Michigan1 site in 1 country12 target enrollmentAugust 1, 2021

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

Registry

clinicaltrials.gov

Start Date

August 1, 2021

End Date

January 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Jaclynn Hawkins

Assistant Professor

University of Michigan

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

Outcomes

Primary Outcomes

Depression

Time Frame: baseline and at 3 months

Measured using the Patient Health Questionnaire (PHQ-9). A PHQ-9 score of 0-4 means none-minimal depression severity, a score of 5-9 means mild depression severity, a score of 10-14 means moderate depression severity, a score of 15-19 means moderately severe depression, and 20-27 means severe depression.

Regimen Adherence

Time Frame: baseline and at 3 months

Measured using the Perceived Diabetes Self-Management Scale (PDSMS), 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. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. For this study, we reported mean change in PDSMS score.

Metabolic Control of A1c (Mean Change in A1C)

Time Frame: baseline and at 3 months

Measured using the DCA 2000 point-of-care testing instrument. The American Diabetes Association recommends people living with diabetes to have an A1C below 7.0%.