Diabetes Education/Skills Training and Social Needs Resolution Intervention

Type 2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935410
• Other study ID #: PRO00046456
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Medical College of Wisconsin
• Contact: Aprill Z Dawson, PhD, MPH
• Phone: 414-955-8828
• Email: adawson[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• DM Social Needs
6-monthly sessions of telephone delivered, manualized education and skills training on diabetes management, and problem solving and resolution of social needs.
• Usual Care
Diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) will be mailed monthly.

Locations

Country	Name	City	State
United States	Aprill Dawson	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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