Combined Diabetes Education/Skills Training and Social Needs Resolution Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (DM Social Needs)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Glycemic Control (Hemoglobin A1C [HbA1C])
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
This study will test the preliminary efficacy of a nurse case-manager, telephone-delivered intervention that provides diabetes self-management education and skills training and resolves the unmet social needs of older African Americans with poorly controlled type 2 diabetes by randomizing 100 African Americans aged 50 years and older with poorly controlled type 2 diabetes to the Combined Diabetes Education/Skills Training and Social Needs Resolution (DM Social Needs) Intervention (n=50) and usual care (n=50) arms.
The aims of this study are:
Aim 1: Test the preliminary efficacy of the DM Social Needs intervention on clinical outcomes in older AAs with uncontrolled type 2 diabetes.
Aim 2: Test the preliminary efficacy of the DM Social Needs intervention on patient reported outcomes in older AAs with uncontrolled type 2 diabetes.
Investigators
Aprill Z. Dawson, PhD, MPH
Assistant Professor
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •Age 50 and older;
- •self-identified as African American or Black;
- •self-reported diagnosis of T2DM;
- •HbA1C \>=8% at the screening visit.
Exclusion Criteria
- •self-reported participation in other diabetes clinical trials;
- •alcohol or drug abuse or dependency as assessed by the CAGE-AID;
- •Mental confusion at screening assessment suggesting significant dementia;
- •life expectancy \< 6 months at screening assessment.
Outcomes
Primary Outcomes
Glycemic Control (Hemoglobin A1C [HbA1C])
Time Frame: Change in baseline HbA1C at 6 months post intervention follow-up
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.