Skip to main content
OpenTrials
Completed

NCT Number: NCT04743778

Online Diabetes Education Project (ODEP)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Diabetes Self-Management Education and Support

Behavioral

Diabetes self-management education and support delivered through Zoom for health.

Primary outcomes

  1. 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%.

  2. 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.

  3. 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.

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: baseline 3 months

    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.

  2. Blood Pressure

    Time frame: baseline and at 3 months

    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.

  3. Diabetes Social Support

    Time frame: baseline and at 3 months

    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.

  4. Diabetes-Related Distress

    Time frame: baseline and at 3 months

    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.

  5. Diabetes Quality of Life

    Time frame: baseline and at 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: ODEP

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 8, 2021
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.