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Family-Focused Diabetes Management for Type 2 Diabetes
N/A
Recruiting
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individual with type 2 diabetes aged 40 years or older
Individual with type 2 diabetes having A1c > 7.5% at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (t1) to six months after intervention (t3) at month 11
Awards & highlights
Study Summary
This trial tests a family-focused intervention to help African Americans with type 2 diabetes improve their quality of life and glycemic control.
Who is the study for?
African American adults over 40 with type 2 diabetes and a family member (spouse, adult child, or sibling) who live together can join. Both must speak English and be able to walk. The patient needs an A1c > 7.5% and diagnosed for at least six months. Those with cognitive impairments, advanced conditions, or unclear diabetes diagnosis are excluded.Check my eligibility
What is being tested?
The trial is testing how well a program designed for African American adults with type 2 diabetes and their family members works in improving blood sugar control and quality of life. It's a randomized controlled study comparing the new intervention against usual care.See study design
What are the potential side effects?
Since this is not a drug trial but an educational intervention focusing on self-management of diabetes within families, there may not be direct side effects like those seen with medication; however, participants might experience stress or time constraints.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 or older with type 2 diabetes.
Select...
My A1c level is above 7.5% and I have type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (t1) to six months after intervention (t3) at month 11
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (t1) to six months after intervention (t3) at month 11
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in diabetes control
Change in health-related quality of life
Secondary outcome measures
Change in blood pressure control
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Patient-family member dyads in the family dyad intervention arm will receive 1) 14 sessions (8 weekly and 6 biweekly) over 20 weeks of family-dyad-focused, in-person group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.
Group II: ControlActive Control1 Intervention
All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study.
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
838 Previous Clinical Trials
507,813 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are African American and have type 2 diabetes.I have type 2 diabetes but no definitive proof of it.I have type 2 diabetes and can walk.I am 40 or older with type 2 diabetes.You have type 2 diabetes and a family member who is willing to join the study with you.I have been diagnosed with type 2 diabetes for over six months.You have type 2 diabetes and your family members cannot make decisions for you.I am over 18 and live with someone who has type 2 diabetes.My family members can walk.You have type 2 diabetes and a family member who is pregnant or has a serious illness.My A1c level is above 7.5% and I have type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
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.
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