Viewing Study NCT04743778



Ignite Creation Date: 2024-05-06 @ 3:45 PM
Last Modification Date: 2024-10-26 @ 1:56 PM
Study NCT ID: NCT04743778
Status: COMPLETED
Last Update Posted: 2024-02-07
First Post: 2021-02-04

Brief Title: Online Diabetes Education Project ODEP
Sponsor: University of Michigan
Organization: University of Michigan

Study Overview

Official Title: Online Diabetes Education Project Virtual Diabetes Self-Management Education and Support Intervention
Status: COMPLETED
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ODEP
Brief Summary: This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support DSMES for African AmericanBlack adults with type 2 diabetes living in Detroit Participants will be randomized to either a control group or the virtual DSMES group
Detailed Description: This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support DSMES for African AmericanBlack 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 5050 randomization scheme participants will be randomized to either a control group or the virtual DSMES 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 DSMES group will receive 10-weekly 1-hour virtual DSMES 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 DSMES

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
P30DK092926 NIH None httpsreporternihgovquickSearchP30DK092926