← Back to Search

Family vs Standard Diabetes Education for Type 2 Diabetes

N/A

Waitlist Available

Led By Pearl McElfish, PhD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have T2D (HbA1c ≥ 7.0)

Be older than 18 years old

Must not have

Have received formal DSME in the past three years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of a diabetes education program that includes family members to a diabetes education program that does not include family members.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since this trial involves educational interventions rather than medications, there are no direct medical side effects expected from participating. However, participants may experience stress or time commitment related to attending educational sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My diabetes is not well-controlled (HbA1c ≥ 7.0).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean HbA1c (NGSP%) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Secondary study objectives

Change in diabetes self-efficacy from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention

Change in diabetes self-management behaviors from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention

Change in diabetes-related distress from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

0 / 2Eligibility criteria met