Online Diabetes Education Project (ODEP) (ODEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Virtual Diabetes Self-Management Education and Support

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Diabetes Self-Management Education and Support; 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.

Behavioral: Virtual Diabetes Self-Management Education and Support; Diabetes self-management education and support delivered through Zoom for health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic Control of A1c (Mean Change in A1C)	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%.	baseline and at 3 months
Depression	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.	baseline and at 3 months
Regimen Adherence	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.	baseline and at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	Calculated using height and weight. Height will be measured using a stadiometer. Weight will be measured on a high quality, calibrated digital scale. Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater For this study, we reported the mean change in BMI.	baseline 3 months
Blood Pressure	Measured using the auscultatory method. The American Diabetes Association recommends people living with type 2 diabetes to have a blood pressure target of 130/80 mmHg.	baseline and at 3 months
Diabetes Social Support	Measured using the Chronic Illness Resources Survey. This survey has a minimum score of 22 and a maximum score of 110. The higher the value, the more support and resources someone has for managing their illness. We measured the mean change in score.	baseline and at 3 months
Diabetes-Related Distress	Measured using the Diabetes Distress Scale. The score is calculated by averaging 17 items on the questionnaire. Scores range from 1 to 6, with 1 being the least distressed and 6 being the most distressed. We consider a mean item score of 3 or higher (moderate distress) as a level of distress worthy of clinical attention. We reported the mean change in diabetes distress below.	baseline and at 3 months
Diabetes Quality of Life	Measured using the Diabetes Quality of Life Questionnaire. The 46-item DQoL scale consists of four domains and is measured using a 5-point Likert scale, where scores are averaged across all domains and summed. Scores range from 0 to 100. The higher the score, the higher the quality of life. We reported the mean change below.	baseline and at 3 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jaclynn Hawkins, MSW, PhD, University of Michigan, School of Social Work

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ODEP HUM00190508; P30DK092926 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No