Skip to main content
OpenTrials
Completed

NCT Number: NCT05935410

Diabetes Education/Skills Training and Social Needs Resolution Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aprill Dawson

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DM Social Needs

Behavioral

6-monthly sessions of telephone delivered, manualized education and skills training on diabetes management, and problem solving and resolution of social needs.

Usual Care

Behavioral

Diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) will be mailed monthly.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.