Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

The investigators conducted a comparative effectiveness randomized controlled trial comparing a family model diabetes self-management education and support intervention (Family-DSMES) and a standard model DSMES intervention (Standard-DSMES). The trial included 550 persons with type 2 diabetes mellitus (PWD) and 550 of their family members/support persons. PWD were randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm. In the Family-DSMES arm, the family members/support persons of the PWD took part in the educational sessions. In the Standard-DSMES arm, the family members/support persons did not participate in educational sessions or goal setting. Both interventions were delivered in a group setting via telehealth. Baseline, immediate post-intervention (12 weeks) and 6 months post-intervention data were collected from PWD and family members/support persons in both study arms. In both study arms, we obtained a medical records release to abstract the primary outcome at 12 months post-intervention and 18 months post-intervention for PWD. The primary outcome was change in Hemoglobin A1c between baseline and immediate post-intervention among PWD.

Key facts

Study ID

NCT04334109

Run by

University of Arkansas

People needed

1100

Starts

2021-01-04

Expected to finish

2024-09-17

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• adults ≥18 years of age
• have HbA1c ≥ 7.0%
• speak English
• have a family member/support person willing to take part in the study

You may not qualify if…

• have received formal DSMES in the past three years
• have a condition that makes it unlikely for them to be able to follow the study protocol, such as a terminal illness
• have plans to move out of the area within 18 months

Where it is running

• University of Arkansas for Medical Sciences Northwest — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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