Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

University of Arkansas

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Family Diabetes Self-Management Education and Support; Behavioral: Standard Diabetes Self-Management Education and Support

Study type: Interventional

Funder types: Other

Identifiers

NCT04334109

260059

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Family-DSME

Experimental group

Description:

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)

Treatment:

Behavioral: Family Diabetes Self-Management Education and Support

Standard-DSME

Active Comparator group

Description:

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)

Treatment:

Behavioral: Standard Diabetes Self-Management Education and Support