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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My diabetes is not well-controlled (HbA1c ≥ 7.0).
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
549 Previous Clinical Trials
29,995,576 Total Patients Enrolled
University of ArkansasLead Sponsor
486 Previous Clinical Trials
149,153 Total Patients Enrolled
Pearl McElfish, PhDPrincipal InvestigatorUAMS
3 Previous Clinical Trials
2,168 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have completed a diabetes self-management education program in the last 3 years.My diabetes is not well-controlled (HbA1c ≥ 7.0).
Research Study Groups:
This trial has the following groups:- Group 1: Standard-DSME
- Group 2: Family-DSME
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants may partake in this experiment at any given time?
"Affirmative. Clinical trials data hosted on the website indicates that this clinical trial is presently looking for participants, and was first made public on April 1st 2021 with a recent update occurring October 19th 2022. 1200 individuals are required to be recruited from one medical site."
Answered by AI
Is this research recruiting participants at the present time?
"According to the data available on clinicaltrials.gov, enrollment for this medical trial is still in progress. It was made public on April 1st 2021 and most recently revised October 19th 2022."
Answered by AI
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