RECRUITING

Family Model DSME in FBOs in the RMI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands

Quick Facts

Study Start:2023-06-30
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05502016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * self-reported Marshallese
  2. * 18 years of age or older
  3. * have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)
  4. * have at least one family member willing to take part in the study
  1. * has received diabetes self-management education in the past five years
  2. * 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
  3. * plans to move out of the geographic region

Contacts and Locations

Study Contact

Betsy O'Connor, MA
CONTACT
479-713-8000
geoconnor@uams.edu
Brett Rowland, MA
CONTACT
479-713-8000
mbrowland@uams.edu

Principal Investigator

Pearl McElfish, PhD
PRINCIPAL_INVESTIGATOR
University of Arkansas

Study Locations (Sites)

UAMS Community Health and Research
Springdale, Arkansas, 72764
United States

Collaborators and Investigators

Sponsor: University of Arkansas

  • Pearl McElfish, PhD, PRINCIPAL_INVESTIGATOR, University of Arkansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-30
Study Completion Date2027-01

Study Record Updates

Study Start Date2023-06-30
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2