Diabetes Education/Skills Training and Social Needs Resolution Intervention

Study 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.

Official Title
-----------------
Combined Diabetes Education/Skills Training and Social Needs Resolution Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (DM Social Needs)

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: DM Social Needs
* Behavioral: Usual Care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DM Social Needs Intervention<br>A trained health educator will deliver the manualized DM Social Needs intervention. Participants will receive 6-monthly sessions of diabetes education and skills training, and problem solving and resolution of social needs via telephone. | Behavioral: DM Social Needs<br>* 6-monthly sessions of telephone delivered, manualized education and skills training on diabetes management, and problem solving and resolution of social needs.<br>|
| Active Comparator: Usual Care<br>Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly | Behavioral: Usual Care<br>* Diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) will be mailed monthly.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control (Hemoglobin A1C [HbA1C]) | About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing. | Change in baseline HbA1C at 6 months post intervention follow-up |