Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

NCT04334109 | Completed Results

• 1 other identifier: 260059
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes self-management education and support; type 2 diabetes; comparative effectiveness; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c)

  A Siemens DCA Vantage analyzer was utilized to collect HbA1c from participants via finger stick blood collection (except for 12 months post-intervention and 18 months post-intervention, which was collected through medical record abstractions).

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

Secondary Outcomes (25)

• Body Mass Index (BMI)

  Baseline, immediate post-intervention, 6 months post-intervention

• Systolic Blood Pressure

  Baseline, immediate post-intervention, 6 months post-intervention

• Diastolic Blood Pressure

  Baseline, immediate post-intervention, 6 months post-intervention

• Glucose

  Baseline, immediate post-intervention

• Total Cholesterol

  Baseline, immediate post-intervention

Study Arms (2)

Family-DSMES

EXPERIMENTAL

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.

Behavioral: Family-DSMES

Standard-DSMES

ACTIVE COMPARATOR

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.

Behavioral: Standard-DSMES

Interventions

Family-DSMES BEHAVIORAL

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.

Family-DSMES

Standard-DSMES 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-DSMES

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 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

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 (2)

• 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 BACKGROUND

• Andersen JA, McElfish PA, Selig JP, Li J, Rowland B, Hudson J, Kraleti S, Henske J, Mayberry LS. Comparative effectiveness of telehealth-delivered family and standard models of diabetes self-management education and support for persons with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2026 Feb;232:113063. doi: 10.1016/j.diabres.2025.113063. Epub 2025 Dec 20.

  PMID: 41429275 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was implemented via telehealth, and results may have differed if offered via in-person group sessions. While participants were diverse (race/ethnicity, rural/urban), all participants were from Arkansas, which reduces generalizability. Participants had to have a family member/support person to participate with them, which precluded some potential participants. Survey metrics were assessed only at baseline and immediate post-intervention, so durability of findings cannot be assessed.

Results Point of Contact

• Title: Dr. Pearl McElfish
• Organization: University of Arkansas for Medical Sciences

pamcelfish@uams.edu

(479)713-8102

Study Officials

• Pearl McElfish, PhD

  UAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: June 22, 2026
• Results First Posted: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)