FDSMEFBO: Family Model Diabetes Self-Management Education in Faith Based Organizations

Sponsor

University of Arkansas (Other)

Overall Status

Recruiting

CT.gov ID

NCT04256486

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

576

Enrollment

Location

Arms

37.4

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Behavioral: Family Model Diabetes Self-Management Education and Support	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

576 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Family Model Diabetes Self-Management Education in Faith Based Organizations

Actual Study Start Date :

Apr 21, 2022

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Family DSMES	Behavioral: Family Model Diabetes Self-Management Education and Support Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.
Experimental: Wait List	Behavioral: Family Model Diabetes Self-Management Education and Support Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.

Arm

Intervention/Treatment

Experimental: Family DSMES

Behavioral: Family Model Diabetes Self-Management Education and Support

Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.

Experimental: Wait List

Behavioral: Family Model Diabetes Self-Management Education and Support

Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.

Outcome Measures

Primary Outcome Measures

Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points [Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAMS Northwest	Springdale	Arkansas	United States	72762

Sponsors and Collaborators

University of Arkansas
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Principal Investigator: Pearl McElfish, Phd, MDA, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT04256486

Other Study ID Numbers:

229034
1R01MD013852-01

First Posted:

Feb 5, 2020

Last Update Posted:

Apr 26, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Arkansas

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Apr 26, 2022