Diabetes Education/Skills Training and Social Needs Resolution Intervention

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes

• 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

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