Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes (ENRxICH)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
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 ≥ 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
376 participants in 4 patient groups
Trial contacts and locations
Loading...
Central trial contact
Martha Maurer
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal