Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

NCT ID: NCT04334109

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2024-09-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Family-DSME

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)

Group Type: EXPERIMENTAL

Family Diabetes Self-Management Education and Support

Intervention Type: 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.

Standard-DSME

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)

Group Type: ACTIVE_COMPARATOR

Standard Diabetes Self-Management Education and Support

Intervention Type: 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.

Interventions

Family Diabetes Self-Management Education and Support

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.

Intervention Type: BEHAVIORAL

Standard Diabetes Self-Management Education and Support

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pearl McElfish, PhD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Locations

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36096282 (View on PubMed)

Other Identifiers

260059

Identifier Type: -

Identifier Source: org_study_id