Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

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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)

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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