Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Wisconsin, Madison
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MTM
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
376 Participants
are divided into 4 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Medication Therapy Management (MTM)Experimental treatment 1 intervention
Group C: Community Health Worker (CHW)Experimental treatment 1 intervention
Group D: MTM + CHWExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in mean hemoglobin A1c score
HbA1c will be measured, and the mean change will be compared across arms
Time frame
Baseline to 6 months2
Change in mean hemoglobin A1c score
HbA1c will be measured, and the mean change will be compared across arms
Time frame
Baseline to 12 monthsSecondary outcomes
1
Change in medication adherence - medication refill
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.
Time frame
6 months and 12 months2
Mean scores on the Adherence to Refills and Medications Scale for Diabetes
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.
Time frame
6 months and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov