Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05912647
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes
  • Diabetes Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Feb 3, 2024
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
376 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Care
  • Experimental: Medication Therapy Management (MTM)
  • Experimental: Community Health Worker (CHW)
  • Experimental: MTM + CHW

Primary Outcome Measure

Change in mean hemoglobin A1c score [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Martha Maurer
[email protected]
608-265-2662

Find similar trials in Madison, WI

By research site
University of Wisconsin· Madison, WI

Related Studies