Family Model Diabetes Self-Management Education in Faith Based Organizations (FDSMEFBO)
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Model Diabetes Self-Management Education and Support
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes focused on measuring Family Model, Marshallese, Pacific Islander, Diabetes Education
Eligibility Criteria
Inclusion Criteria:
- self-reported Marshallese
- 18 years of age or older
- have T2D (defined as having an HbA1c equal to or greater than 6.5)
- have at least one family member willing to take part
Exclusion Criteria:
- has received DSME in the past five years
- has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
- plans to move out of the geographic region
Sites / Locations
- UAMS NorthwestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Family DSMES
Wait List
Arm Description
Outcomes
Primary Outcome Measures
Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points
Measured by Change in Adjusted Mean HbA1c(%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, and 24 Months Post-intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT04256486
First Posted
February 3, 2020
Last Updated
January 8, 2023
Sponsor
University of Arkansas
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT04256486
Brief Title
Family Model Diabetes Self-Management Education in Faith Based Organizations
Acronym
FDSMEFBO
Official Title
Family Model Diabetes Self-Management Education in Faith Based Organizations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Family Model, Marshallese, Pacific Islander, Diabetes Education
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
576 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Family DSMES
Arm Type
Experimental
Arm Title
Wait List
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Family Model Diabetes Self-Management Education and Support
Intervention Description
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.
Primary Outcome Measure Information:
Title
Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points
Description
Measured by Change in Adjusted Mean HbA1c(%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, and 24 Months Post-intervention.
Time Frame
Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
self-reported Marshallese
18 years of age or older
have T2D (defined as having an HbA1c equal to or greater than 6.5)
have at least one family member willing to take part
Exclusion Criteria:
has received DSME in the past five years
has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
plans to move out of the geographic region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Betsy O'Connor, MA, BS
Phone
479-713-8687
Email
geoconnor@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brett Rowland, MA, BS
Phone
479-713-8667
Email
mbrowland@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pearl McElfish, Phd, MDA
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAMS Northwest
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine Boyers Schuh, MA
Email
JMBoyersschuh@uams.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Family Model Diabetes Self-Management Education in Faith Based Organizations
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