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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

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 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

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)

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
568 Previous Clinical Trials
27,248,209 Total Patients Enrolled
University of ArkansasLead Sponsor
493 Previous Clinical Trials
149,763 Total Patients Enrolled
Pearl McElfish, PhDPrincipal InvestigatorUAMS
3 Previous Clinical Trials
2,168 Total Patients Enrolled

Media Library

Family Diabetes Self-Management Education and Support Clinical Trial Eligibility Overview. Trial Name: NCT04334109 — N/A
Type 2 Diabetes Research Study Groups: Standard-DSME, Family-DSME
Type 2 Diabetes Clinical Trial 2023: Family Diabetes Self-Management Education and Support Highlights & Side Effects. Trial Name: NCT04334109 — N/A
Family Diabetes Self-Management Education and Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT04334109 — N/A
~257 spots leftby Sep 2025
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