Diabetes Education/Skills Training and Social Needs Resolution Intervention

Medical College of Wisconsin

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Usual Care; Behavioral: DM Social Needs

Study type: Interventional

Funder types: Other

Identifiers

NCT05935410

PRO00046456

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

DM Social Needs Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: DM Social Needs

Usual Care

Active Comparator group

Description:

Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly

Treatment:

Behavioral: Usual Care