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Online Diabetes Education Project (ODEP) (ODEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743778
Recruitment Status : Completed
First Posted : February 8, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Jaclynn Hawkins, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Virtual Diabetes Self-Management Education and Support Behavioral: Resources Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Online Diabetes Education Project: Virtual Diabetes Self-Management Education and Support Intervention
Actual Study Start Date : August 1, 2021
Actual Primary Completion Date : December 20, 2021
Actual Study Completion Date : January 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Virtual Diabetes Self-Management Education and Support
Participants randomized into the virtual empowerment-based DSME/S group 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.
Active Comparator: Control Group
Participants randomized to enhanced usual care will receive referrals to community mental health providers, pedometers, gym memberships to a community-based venue, and intervention patient manuals. Based on several years of experience in Detroit, providing all participants with referrals, pedometers, and educational materials minimizes ethical concerns regarding assignment of underserved populations to receive a no-treatment control.
 Behavioral: Resources
Newsletters, pedometers, and community resources.


Outcome Measures
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Primary Outcome Measures :
  1. Metabolic Control of A1c [ Time Frame: 6 months ]
    Measured using the DCA 2000 point-of-care testing instrument

  2. Depression [ Time Frame: 6 months ]
    Measured using the PHQ-9 (score >=10) and the BDI-II

  3. Regimen adherence [ Time Frame: 6 months ]
    Measured using the Perceived Diabetes Self-Management Scale, 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.


Secondary Outcome Measures :
  1. BMI [ Time Frame: 6 months ]
    Calculated using height and weight. Height will be measured using a stadiometer. Weight will be measured on a high quality, calibrated digital scale.

  2. Blood pressure [ Time Frame: 6 months ]
    Measured using the auscultatory method.

  3. Diabetes Social Support [ Time Frame: 6 months ]
    Measured using the Diabetes Social Support Questionnaire

  4. Diabetes-related Distress [ Time Frame: 6 months ]
    Measured using the Diabetes Distress Scale (SF-12)

  5. Diabetes Quality of Life [ Time Frame: 6 months ]
    Measured using the Diabetes Quality of Life Questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743778


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
More Information
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Responsible Party: Jaclynn Hawkins, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04743778    
Other Study ID Numbers: ODEP HUM00190508
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases