Family vs Standard Diabetes Education for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen byPearl McElfish, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with type 2 diabetes (HbA1c ≥ 7.0) who have not had formal diabetes education in the past three years and have a family member willing to participate. It's not suitable for those unable to follow the study protocol due to other conditions.

Inclusion Criteria

I am 18 years old or older.

Speak English

Have a family member willing to take part in the study

See 1 more

Exclusion Criteria

I have completed a diabetes self-management education program in the last 3 years.

Have a condition that makes it unlikely for them to be able to follow the protocol

Treatment Details

Interventions

Family Diabetes Self-Management Education and Support (Behavioral Intervention)
Standard Diabetes Self-Management Education and Support (Behavioral Intervention)

Trial OverviewThe trial compares two types of diabetes education: one where patients alone receive standard self-management support, and another where a patient's family member also gets involved in learning sessions. Each group will include 300 patients, randomly assigned.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Family-DSMEExperimental Treatment1 Intervention

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 II: Standard-DSMEActive Control1 Intervention

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)