DiabetesENRxICHNCT05912647
Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes
A study testing MTM and CHW in people with Diabetes and Diabetes Type 2, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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 adults with type 2 diabetes and find out which of type of support may improve diabetes… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes, Diabetes Type 2
- What is being tested?
- MTM and CHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Martha Maurer, 608-265-2662, mamaurer@wisc.edu
About this study
Official title: A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients With Uncontrolled Diabetes
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
Read the 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.
- Conditions
- Diabetes, Diabetes Type 2
- Being tested
- MTM, CHW
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTMBehavioural
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.
CHWBehavioural
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 group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| Medication Therapy Management (MTM) | Experimental | Not described Receives: Behavioral: MTM |
| Community Health Worker (CHW) | Experimental | Not described Receives: Behavioral: CHW |
| MTM + CHW | Experimental | Not described Receives: Behavioral: MTM; Behavioral: CHW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean hemoglobin A1c score
HbA1c will be measured, and the mean change will be compared across arms
Measured: Baseline to 6 months
Change in mean hemoglobin A1c score
HbA1c will be measured, and the mean change will be compared across arms
Measured: Baseline to 12 months
Secondary outcomes (2)
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.
Measured: 6 months and 12 months
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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start3 Feb 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Chui, PharmD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912647
- Sponsor's protocol ID
- 2023-0780
- Other IDs
- 1R01DK136690-01, PHARM/PHARMACY, Protocol Version 5/6/26
- Acronym
- ENRxICH
- Status last verified
- May 2026
- First submitted
- 12 Jun 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Shiyanbola OO, Maurer MA, Piper ME, Bolt D, Sharp LK, Ouayogode MH, Fisher E. Optimizing diabetes management interventions for Black and Hispanic adults using the multiphase optimization strategy: Protocol for a randomized mixed methods factorial trial. Contemp Clin Trials. 2025 Feb;149:107804. doi: 10.1016/j.cct.2024.107804. Epub 2025 Jan 4.
PubMed 39761827
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients With Uncontrolled Diabetes
- ClinicalTrials.gov ID
- NCT05912647
- Acronym / sponsor ID
- ENRxICH / 2023-0780
- Conditions
- Diabetes, Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | – |
| Medication Therapy Management (MTM) | Experimental | Behavioral: MTM |
| Community Health Worker (CHW) | Experimental | Behavioral: CHW |
| MTM + CHW | Experimental | Behavioral: MTM, Behavioral: CHW |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTMParticipants 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. | Behavioural | MTM + CHW, Medication Therapy Management (MTM) |
| CHWParticipants 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. | Behavioural | Community Health Worker (CHW), MTM + CHW |
Primary outcome
Change in mean hemoglobin A1c score
Time frame: Baseline to 6 months
HbA1c will be measured, and the mean change will be compared across arms
Change in mean hemoglobin A1c score
Time frame: Baseline to 12 months
HbA1c will be measured, and the mean change will be compared across arms
2 secondary outcomes
Change in medication adherence - medication refill
Time frame: 6 months and 12 months
Mean scores on the Adherence to Refills and Medications Scale for Diabetes
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Derived from this study: PubMed 39761827Shiyanbola OO, Maurer MA, Piper ME, Bolt D, Sharp LK, Ouayogode MH, Fisher E. Optimizing diabetes management interventions for Black and Hispanic adults using the multiphase optimization strategy: Protocol for a randomized mixed methods factorial trial. Contemp Clin Trials. 2025 Feb;149:107804. doi: 10.1016/j.cct.2024.107804. Epub 2025 Jan 4.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Chui, PharmD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTM and CHW in people with Diabetes and Diabetes Type 2, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Maurer (608-265-2662, mamaurer@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean hemoglobin A1c score (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.