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Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
Sponsor: University of Arkansas
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2021-01-04
Completion Date
2024-09-17
Last Updated
2026-06-22
Healthy Volunteers
Yes
Conditions
Interventions
Family-DSMES
Family Diabetes Self-Management Education and Support demonstrates the effectiveness of family-centered models of DSMES that explicitly address diabetes self-management within a family context by educating both patients and family members and focusing on family motivational interviewing, family goal setting, understanding supportive and non-supportive behaviors, and family behavioral changes.
Standard-DSMES
Diabetes Self-Management Education and Support demonstrates the effectiveness of individual model DSMES that explicitly address diabetes self-management within an individual context by educating individual patients on individual motivational interviewing, individual goal setting, and individual behavioral changes.
Locations (1)
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, United States