Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes (ENRxICH)

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

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 adults with type 2 diabetes and find out which of type of support may improve diabetes self-management for 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

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Diabetes Type 2
• Intervention / Treatment: Behavioral: MTM; Behavioral: CHW

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 376
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martha Maurer; Phone Number: 608-265-2662; Email: mamaurer@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Martha Maurer; Phone Number: 608-265-2662; Email: mamaurer@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women ages 18-90 with diagnosed type 2 diabetes who speak and understand English or Spanish.
• Taking at least one oral or injectable diabetes medication
• HbA1c ≥ 7.5% 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.
• Women who are pregnant or plan to get pregnant in the next 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Medication Therapy Management (MTM)	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.
Experimental: Community Health Worker (CHW)	Behavioral: 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.
Experimental: MTM + CHW	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean hemoglobin A1c score	HbA1c will be measured, and the mean change will be compared across arms	Baseline to 6 months
Change in mean hemoglobin A1c score	HbA1c will be measured, and the mean change will be compared across arms	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Michelle Chui, PharmD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2023-0780; PHARM/PHARMACY (Other Identifier: UW Madison); 1R01DK136690-01 (U.S. NIH Grant/Contract); Protocol Version 5/6/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No