Diabetes Education/Skills Training and Social Needs Resolution Intervention

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05935410

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
Type 2 Diabetes	Behavioral: DM Social Needs Behavioral: Usual Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

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)

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DM Social Needs Intervention 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 6-monthly sessions of telephone delivered, manualized education and skills training on diabetes management, and problem solving and resolution of social needs.
Active Comparator: Usual Care 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 Diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) will be mailed monthly.

Arm

Intervention/Treatment

Experimental: DM Social Needs Intervention

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

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

Active Comparator: Usual Care

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Principal Investigator: Aprill Z Dawson, PhD, MPH, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aprill Z. Dawson, PhD, MPH, Assistant Professor, Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT05935410

Other Study ID Numbers:

PRO00046456

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 7, 2023