Improving diabetes management for Black and Hispanic patients
A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients With Uncontrolled Diabetes
This study is testing different types of support for Black and Hispanic adults with uncontrolled type 2 diabetes to see which helps them manage their condition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 376 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05912647 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance pharmacy-related care for Black and Hispanic adults with uncontrolled type 2 diabetes by evaluating different support approaches. Participants will be randomly assigned to one of four groups: usual care, medication management support from a pharmacist, support from a Community Health Worker (CHW) addressing life challenges, or a combination of both. The intervention will last for six months, during which participants will receive tailored support to improve their diabetes self-management. The goal is to identify effective strategies that can lead to better health outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are Black or Hispanic adults aged 18-90 with type 2 diabetes who have an HbA1c level of 8% or higher.
Not a fit: Patients who have a caregiver making decisions for their diabetes management or who have participated in similar interventions recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diabetes management and health outcomes for Black and Hispanic patients.
How similar studies have performed: Other studies have shown success in enhancing diabetes management through similar community-based and pharmacist-led interventions.
Eligibility criteria
Show full inclusion / exclusion 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 ≥ 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.
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Chui, PharmD, PhD — University of Wisconsin, Madison
- Study coordinator: Martha Maurer
- Email: mamaurer@wisc.edu
- Phone: 608-265-2662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.