Diabetes Education/Skills Training and Social Needs Resolution Intervention

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: DM Social Needs; Behavioral: Usual Care

• Registration Number: NCT05935410
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-07
• Study Start: 2023-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 50 and older;
2. self-identified as African American or Black;
3. self-reported diagnosis of T2DM;
4. HbA1C >=8% at the screening visit.

Exclusion Criteria

1. self-reported participation in other diabetes clinical trials;
2. alcohol or drug abuse or dependency as assessed by the CAGE-AID;
3. Mental confusion at screening assessment suggesting significant dementia;
4. life expectancy < 6 months at screening assessment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DM Social Needs Intervention	DM Social Needs	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.
Usual Care	Usual Care	Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly

Primary Outcome Measures

Name	Time	Method
Glycemic Control (Hemoglobin A1C [HbA1C])	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.

Trial Locations

Locations (1)

Aprill Dawson; 🇺🇸 Milwaukee, Wisconsin, United States