Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

NCT ID: NCT05912647

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-03
• Study Completion Date: 2027-12-31

Brief 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 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

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.

Conditions

Diabetes; Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Medication Therapy Management (MTM)

Group Type: EXPERIMENTAL

MTM

Intervention Type: BEHAVIORAL

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.

Community Health Worker (CHW)

Group Type: EXPERIMENTAL

CHW

Intervention Type: BEHAVIORAL

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.

MTM + CHW

Group Type: EXPERIMENTAL

MTM

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 ≥ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Chui, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Martha Maurer

Role: CONTACT

mamaurer@wisc.edu

608-265-2662

Facility Contacts

Martha Maurer

Role: primary

mamaurer@wisc.edu

608-265-2662

Other Identifiers

1R01DK136690-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PHARM/PHARMACY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 5/23/25

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0780

Identifier Type: -

Identifier Source: org_study_id