Clinical trial NCT05912647: Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes
Official title: A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients With Uncontrolled Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Diabetes Type 2
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-06-22
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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

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.

Eligibility criteria: Inclusion Criteria:

* Men and women ages 18-90 with diagnosed type 2 diabetes who self-identify as Black or Hispanic and can 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.

Primary outcomes:
measure: Change in mean hemoglobin A1c score
timeFrame: Baseline to 6 months
measure: Change in mean hemoglobin A1c score
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in medication adherence - medication refill
timeFrame: 6 months and 12 months
measure: Mean scores on the Adherence to Refills and Medications Scale for Diabetes
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michelle Chui, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: