Online Diabetes Education Project (ODEP)

NCT04743778 | Completed Results DMC

• 2 other identifiers: ODEP HUM00190508P30DK092926
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Body Mass Index (BMI)

  baseline 3 months

• Blood Pressure

  baseline and at 3 months

• Diabetes Social Support

  baseline and at 3 months

• Diabetes-Related Distress

  baseline and at 3 months

• Diabetes Quality of Life

  baseline and at 3 months

Study Arms (1)

Virtual Diabetes Self-Management Education and Support

EXPERIMENTAL

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

Interventions

Virtual Diabetes Self-Management Education and Support BEHAVIORAL

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

Virtual Diabetes Self-Management Education and Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agee 18 or older, Black, a diagnosis of T2D for one year duration or longer, ambulatory status.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Jaclynn Hawkins
• Organization: University of Michigan, School of Social Work

jachawk@umich.edu

(734) 615-2817

Study Officials

• Jaclynn Hawkins, MSW, PhD

  University of Michigan, School of Social Work

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 8, 2021
• Study Start: August 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: January 31, 2022
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-02

Locations

US (1)