Diabetes Education/Skills Training and Social Needs Resolution Intervention

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05935410

Enrollment

100

Registered

2023-07-07

Start date

2023-08-01

Completion date

2025-12-15

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

BEHAVIORALDM Social Needs

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

BEHAVIORALUsual Care

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAprill Z Dawson, PhD, MPH

Medical College of Wisconsin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026