At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
In Brief
A clinical study evaluating Family-DSMES and Standard-DSMES for Diabetes Mellitus, Type 2. Completed, enrolled 1,100 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
The Family-DSMES intervention uses family motivational interviewing techniques and family goal setting, and focuses on understanding supportive and non-supportive family behaviors and creating family level behavioral change. Family-DSMES is delivered in group sessions via telehealth by a certified diabetes care and education specialist (CDCES) to patients and their family members. The intervention includes 10 hours of education delivered over 10 weeks in one-hour sessions. Family members in the Family-DSMES arm take part in educational sessions and data collection.
The Standard-DSMES intervention uses individual motivational interviewing techniques and individual goal setting, and focuses on creating individual level behavioral change. Standard-DSMES is delivered in group sessions via telehealth by a certified diabetes care and education specialist (CDCES) to patients only. The intervention includes 10 hours of education delivered over 10 weeks in one-hour sessions. Family members take part in data collection but do not take part in educational sessions.
Interventions
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.
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.