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Family Model DSME in FBOs in the RMI

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Model Diabetes Self-Management Education and Support
Family Model Diabetes Self-Management Education and Support (Wait-list)
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • self-reported Marshallese
  • 18 years of age or older
  • have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)
  • have at least one family member willing to take part in the study

Exclusion Criteria:

  • has received diabetes self-management education 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 Community Health and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Wait-list Control

Arm Description

Family model diabetes self-management education and support

Family model diabetes self-management education and support

Outcomes

Primary Outcome Measures

Glycemic control, measured by change in mean HbA1c (%) from baseline
Point of care tests will be utilized to calculate HbA1c levels for each participant. The primary outcome measure is change in mean HbA1c (%) from baseline to immediate post-intervention, 4 months post-intervention, and 12 months post-intervention. Analyses will be adjusted for baseline HbA1c, sex, age, education, marital status, employment status, use of diabetes medications, and clustering of participants within churches.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2022
Last Updated
July 12, 2023
Sponsor
University of Arkansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05502016
Brief Title
Family Model DSME in FBOs in the RMI
Official Title
Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Health disparities in the Republic of the Marshall Islands are striking, with extremely high rates of type 2 diabetes. Documented prevalence of type 2 diabetes in the Marshall Islands ranges from 20%-50%.This is significantly higher than the global (8.5%) and United States (11%) prevalence. Diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. Diabetes self-management education and support is critical for persons with diabetes. This study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in Marshallese by trained community health workers. The study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. The primary study outcome will be glycemic control as measured by HbA1c. Secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. Survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. The control arm of the study will have two pre-intervention data collections before beginning the intervention. Data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Family model diabetes self-management education and support
Arm Title
Wait-list Control
Arm Type
Active Comparator
Arm Description
Family model diabetes self-management education and support
Intervention Type
Behavioral
Intervention Name(s)
Family Model Diabetes Self-Management Education and Support
Intervention Description
Participants assigned to this arm receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.
Intervention Type
Behavioral
Intervention Name(s)
Family Model Diabetes Self-Management Education and Support (Wait-list)
Intervention Description
Participants assigned to this arm will wait approximately 12 weeks to receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.
Primary Outcome Measure Information:
Title
Glycemic control, measured by change in mean HbA1c (%) from baseline
Description
Point of care tests will be utilized to calculate HbA1c levels for each participant. The primary outcome measure is change in mean HbA1c (%) from baseline to immediate post-intervention, 4 months post-intervention, and 12 months post-intervention. Analyses will be adjusted for baseline HbA1c, sex, age, education, marital status, employment status, use of diabetes medications, and clustering of participants within churches.
Time Frame
Baseline, Immediate post-intervention, 4 months post-intervention, 12 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 type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%) have at least one family member willing to take part in the study Exclusion Criteria: has received diabetes self-management education 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
Phone
479-713-8000
Email
geoconnor@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brett Rowland, MA
Phone
479-713-8000
Email
mbrowland@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pearl McElfish, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAMS Community Health and Research
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine Boyers Schuh, MA
Phone
479-713-8000
Email
jmboyersschuh@uams.edu

12. IPD Sharing Statement

Learn more about this trial

Family Model DSME in FBOs in the RMI

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