CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 221 enrolled
Drug / intervention
Adapted DSME +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02407132
NCT02407132N/ACompleted

Family Model of Diabetes Self-Management Education in the Marshallese Community

University of Arkansas·interventional·Posted Apr 2, 2015·Updated Jun 20, 2019

In Brief

A clinical study evaluating Adapted DSME and Standard DSME for Diabetes. Completed, enrolled 221 participants across 1 site.

Detailed Summary

The investigators will conduct a comparative effectiveness evaluation using a randomized control trial design of a culturally adapted family model of Diabetes Self-Management Education (Adapted DSME) compared with Standard DSME within the Marshallese population. The family model will cover the same concepts as the standard format. However, the family model will incorporate culturally-adapted education and recommendations aimed at engaging family members in the management of the primary participant's diabetes, and family members will be invited to fully participate in the study. By contrast, the standard model provides diabetes self- management education to the diabetic participant only, and the participant's family members do not participate in the classes or any other part of the study. Biometric and survey data will be collected pre-intervention, post-intervention, 6 months post-intervention, and 12 months post-intervention. A qualitative debriefing session will be held for each family between the final DSME session and the 6 month post-intervention to obtain qualitative data regarding the participant's perceptions of the intervention and implementation process.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2, 2015
Enrollment StartJun 1, 2015
Primary CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.3 years ago

Interventions

Adapted DSMEbehavioral

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

Standard DSMEbehavioral

Active Comparator: Standard DSME Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.