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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

No Placebo-Only Group

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.

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.

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 below

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I am 40 or older with type 2 diabetes.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t1) to six months after intervention (t3) at month 11 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 diabetes control

Change in health-related quality of life

Secondary study objectives

Change in blood pressure control

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: 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.

0 / 2Eligibility criteria met