Diabetes Education/Skills Training and Social Needs Resolution Intervention

NCT05935410 | Completed

• 1 other identifier: PRO00046456
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DM Social Needs Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

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.

DM Social Needs Intervention

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Aprill Dawson

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Aprill Z Dawson, PhD, MPH

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 7, 2023
• Study Start: August 1, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)