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

Diabetes Clinical Trial

— ENRxICH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912647
• Other study ID #: 2023-0780
• Secondary ID: PHARM/PHARMACYPr
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: Martha Maurer
• Phone: 608-265-2662
• Email: mamaurer[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 376
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Men and women ages 18-90 with diagnosed type 2 diabetes who self-identify as Black or Hispanic and can speak or read English or Spanish.

• Taking at least one oral or injectable diabetes medication and have their diabetes medicine prescriptions filled by study pharmacy.

• HbA1c = 8% based on point of care test.

• Will reside in the geographical area throughout the study period.

• Have access to a phone during the study period.

• Willing to attend all orientation/training sessions.

Exclusion Criteria:

• Having a caregiver who is the main decision maker in self-management.

• Participating in another lifestyle, or medication adherence program.

• Participated in standard MTM/MTM-related intervention in the last 6 months.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• MTM
Participants will receive added medicine management support from a pharmacist. This will involve one 60-minute session with the pharmacist either in-person or over the phone and at least four 30-minute follow-up sessions with the pharmacist over the phone.
• CHW
Participants will receive support from a Community Health Worker (CHW) to address life challenges that might be affecting their health and diabetes and to discuss diabetes beliefs and concerns. This will involve one ~30-minute phone call with the CHW to discuss needs and a 2-hour session with the CHW in-person for a comprehensive assessment. Participants will also receive ~10, 15 to 30-minute calls from the CHW to discuss diabetes beliefs and concerns.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean hemoglobin A1c score	HbA1c will be measured, and the mean change will be compared across arms	Baseline to 6 months
Primary	Change in mean hemoglobin A1c score	HbA1c will be measured, and the mean change will be compared across arms	Baseline to 12 months
Secondary	Change in medication adherence - medication refill	Pharmacy medication refill measured by Proportion of Days Covered and Medication Possession Ratio in subjects receiving MTM, CHW support, or both, compared to those receiving usual care.	6 months and 12 months
Secondary	Mean scores on the Adherence to Refills and Medications Scale for Diabetes	Mean scores on the Adherence to Refills and Medications Scale for Diabetes in subjects receiving MTM, CHW support, or both, compared to those receiving usual care. The scores range from 11-44, lower scores indicate better medication adherence.	6 months and 12 months