Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

NCT04334109 | Completed

• 1 other identifier: 260059
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a fully-powered, comparative effectiveness randomized controlled trial that includes up to 600 patients with type 2 diabetes (T2D) and 600 of their family members. Patients with T2D will be randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm, with 300 patients in each arm. In the Family-DSMES arm, one of each patient's family members will take part in the educational sessions (family members defined below). Baseline and follow-up data (immediate post-intervention, 6 months post-intervention, and 12 months post-intervention) will be collected from patients and family members in both study arms. In the Standard-DSMES arm, data will be collected from family members, but they will not participate in educational sessions. In both arms, the investigators will obtain a medical records release to abstract outcomes at 18 months post-intervention.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in mean HbA1c (NGSP%) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

  A Siemens analyzer will be utilized to calculate HbA1c (%) for each participant at every time point (except for 18 months post-intervention, which will be collected through medical record abstractions). Changes in the primary outcome measure will be assessed from baseline to each follow-up time point. The primary analytic approach will use general linear models, including mixed effects linear regression models for continuous repeated measures, to model the mean outcome difference and covariance structures between the treatment arms. Analyses will be adjusted for baseline differences in demographic, socioeconomic, and clinical variables, all within repeated mixed linear regression models. Clustering effects within the intervention delivery groups (i.e., within the DSMES classes) will be accounted for in the model as a random effect. We will adjust for potential clinic variations as a dummy coded variable in our model.

  Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Secondary Outcomes (13)

• Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

  Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

• Change in mean waist circumference from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical record abstraction

  Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

• Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

  Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

• Change in mean total cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

  Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical records abstraction

• Change in mean high-density lipoproteins (HDL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

  Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Study Arms (2)

Family-DSME

EXPERIMENTAL

Approach * Family motivational interviewing techniques * Family goal setting * Understanding supportive and nonsupportive family behaviors * Family behavioral changes Mode of Delivery * Group sessions delivered by a certified diabetes educator (CDE) to patients and their family members Dosage * 10 hours delivered in one-hour sessions over 10 weeks Participants * 300 patients with T2D and 300 family members (family members will take part in educational sessions and data collection)

Behavioral: Family Diabetes Self-Management Education and Support

Standard-DSME

ACTIVE COMPARATOR

Approach * Individual motivational interviewing techniques * Individual goal setting * Individual behavioral changes Mode of Delivery * Group sessions delivered by a CDE to patients Dosage * 10 hours delivered in one-hour sessions over 10 weeks Participants * 300 patients with T2D (family members will take part in data collection but not educational sessions)

Behavioral: Standard Diabetes Self-Management Education and Support

Interventions

Family Diabetes Self-Management Education and Support BEHAVIORAL

Family Diabetes Self-Management Education and Support demonstrates the effectiveness of family-centered models of DSME 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 nonsupportive behaviors, and family behavioral changes.

Family-DSME

Standard Diabetes Self-Management Education and Support BEHAVIORAL

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.

Standard-DSME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults ≥18 years of age
• have T2D (HbA1c ≥ 7.0)
• speak English
• a family member willing to take part in the study

You may not qualify if:

• have received formal DSME in the past three years
• have a condition that makes it unlikely for them to be able to follow the protocol

Sponsors & Collaborators

• University of Arkansas: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, 72703, United States

Location

Related Publications (1)

• Mayberry LS, Felix HC, Hudson J, Curran GM, Long CR, Selig JP, Carleton A, Baig A, Warshaw H, Peyrot M, McElfish PA. Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. Contemp Clin Trials. 2022 Oct;121:106921. doi: 10.1016/j.cct.2022.106921. Epub 2022 Sep 9.

  PMID: 36096282 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pearl McElfish, PhD

  UAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 6, 2020
• Study Start: January 4, 2021
• Primary Completion: May 17, 2023
• Study Completion: September 17, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)