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NCT Number: NCT05912647

Enhancing Diabetes Management Approaches 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

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Location contact

Martha Maurer

CONTACT

[email protected]

608-265-2662

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MTM

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

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.

Primary outcomes

  1. Change in mean hemoglobin A1c score

    Time frame: Baseline to 6 months

    HbA1c will be measured, and the mean change will be compared across arms

  2. Change in mean hemoglobin A1c score

    Time frame: Baseline to 12 months

    HbA1c will be measured, and the mean change will be compared across arms

Secondary outcomes

  1. Change in medication adherence - medication refill

    Time frame: 6 months and 12 months

    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.

  2. Mean scores on the Adherence to Refills and Medications Scale for Diabetes

    Time frame: 6 months and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martha Maurer

CONTACT

[email protected]

608-265-2662

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ENRxICH

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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