Enhancing Diabetes Management Approaches for Black and Hispanic Patients With Uncontrolled Diabetes — ENRxICH  

Diabetes Clinical Trial

Official title: A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Black and Hispanic Patients With Uncontrolled Diabetes

Status Recruiting

Clinical Trial Summary

The purpose of the study is to learn about the best way to enhance pharmacy-related care for diabetes self-management.

This research is being done because we want to improve use of medicines and diabetes management among Black and Hispanic adults with type 2 diabetes and find out which of type of support may improve diabetes self-management for Black and Hispanic adults.

Participants will be assigned to one of 4 groups, and will either:

• receive care as usual; or,

• receive added medicine management support from a pharmacist; or,

• receive support from a Community Health Worker (CHW) to address life challenges; or,

• receive both the pharmacist medicine management and the CHW support

Clinical Trial Description

For the ENRxICH intervention, all participants will receive usual care for their diabetes management. Participants will be randomized to one of four treatment conditions: 1. Usual Care, 2. Medication Therapy Management (MTM) Optimizing Medication Therapy (ON), 3. Community Health Worker (CHW) addressing social determinants of health (SDOH) and diabetes and medicine misperceptions (ON), or 4. both MTM Optimizing Medication Therapy and CHW Addressing SDOH and diabetes and medicine misperceptions for 6 months.

Subjects randomized to the treatment conditions including MTM will receive a minimum of five pharmacist-delivered Medication Therapy Management (MTM) sessions with a pharmacist, two in the first month, one medication review each in the second and third month, and a final medication review at 6 months.

Subjects randomized to the treatment conditions including CHW support addressing social determinants of health (SDOH) which will involve meeting with the CHW for a formal, standardized 2-hour assessment of five common SDOH barriers related to diabetes management, (1) food insecurity, (2) transportation, (3) prescription medication assistance, (4) access to diabetes education, and (5) physical activity resources (See Table 6). After the initial session at the participant's home (or another community location), the participant will have the option of continuing to work with the CHW to address barriers for the intervention duration. CHW support will also address diabetes and medicine misperceptions by completing a series of phone calls with the subject to provide information about managing diabetes and medicines, discuss cultural health misperceptions, share medication adherence experiences, and provide social support over the phone. ;

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

• NCT number: NCT05912647
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Contact: Martha Maurer
• Phone: 608-265-2662
• Email: mamaurer@wisc.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2024
• Completion date: December 2027