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NCT05935410 | RECRUITING | Type 2 Diabetes

Diabetes Education/Skills Training and Social Needs Resolution Intervention
Sponsor:

Medical College of Wisconsin

Information provided by (Responsible Party):

Aprill Z. Dawson, PhD, MPH

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.

Condition or disease

Type 2 Diabetes

Intervention/treatment

DM Social Needs

Usual Care

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : DOUBLE
Primary Purpose : HEALTH_SERVICES_RESEARCH
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)
Actual Study Start Date : 2023-08-01
Estimated Primary Completion Date : 2025-11
Estimated Study Completion Date : 2025-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Diabetes Education/Skills Training and Social Needs Resolution Intervention

Location Details

NCT05935410

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How to Participate

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Locations

RECRUITING

United States, Wisconsin

Aprill Dawson

Milwaukee, Wisconsin, United States, 53226