Clinical trial NCT05442840: Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes
Official title: Evaluation of Pharmacist Intervention and Education in a Patient-Centered, Multidisciplinary Approach for Individuals With Uncontrolled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to 1 of 2 arms, either control or pharmacist intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: Type 2 diabetes is a chronic disease that can lead to a number of complications if uncontrolled and there is a projected increase of 33% patients living with diabetes over the next 10 years. There can be improvements to modifiable risk factors such as diet and exercise, in addition to medications. Treatment often involves a multidisciplinary approach with a physician, endocrinologist, dietitian, pharmacist and other support health professionals as required. This study will evaluate the effects of the pharmacists (or pharmD interns) intervention, looking at changes to the patients HbA1C, which is a measure of the patients blood glucose control over the previous 3 months as well as the patients understanding and comfort with managing their own diabetes via participant survey.

Detailed description: Recruitment will begin in July 2022, potential participants can self-refer or another healthcare provider may discuss the study and provide contact information to the study team for all interested potential participants. These potential participants would then be screened for eligibility by the pharmacist or PharmD (Doctor of Pharmacy) Intern. The goal is to enroll 60 participants in the study. All participants must provide consent to participate and will be asked to complete a participant survey.

All participants who consented will then be randomized into a control group which will not receive pharmacist intervention during the study period, or the intervention group which will receive pharmacist/PharmD Intern led intervention which includes a medication review, optimizing medication treatment options and frequent follow up and diabetes education. The control group participants will be offered pharmacist intervention following the study period. All participants will be asked to complete a participant survey at the start and end of the study. All participants will also have standard care from their physicians and other healthcare team members as required which would be standard of practice. All participants would also be asked to repeat their blood work at the end of the study period.

Eligibility criteria: Inclusion Criteria:

* Patients whose primary care physician is within the Portage Clinic
* Adults (age 18 and older) with type 2 diabetes with HbA1C 10 % or above
* Patients whom have not had previous clinical pharmacist directed intervention
* Agree to participate in the study, including frequent follow up, blood glucose home monitoring as directed and repeat lab work
* Willing to consider medication adjustments as deemed appropriate
* Willing to review and sign the Research Participant Information and Informed Consent Form

Exclusion Criteria:

* Patients less than 18 years of age
* Patients with type 1 diabetes, pre-diabetes or gestational diabetes (or whom are pregnant)
* Patients whom have had recent or ongoing clinical pharmacist directed intervention or intensive health care professional monitoring and guidance
* Patients with HbA1C less than 10%
* Patients whom refuse medication adjustments
* Patients with severe renal impairment or receiving dialysis treatments

Primary outcomes:
measure: Change in Baseline Hemoglobin A1C (HbA1C) at 10 months
timeFrame: baseline and through study completion at 10 months approximately
Secondary outcomes:
measure: Participant Survey
timeFrame: baseline and through study completion at 10 months approximately
measure: Modifiable Risk Factors -Cholesterol Level
timeFrame: baseline and through study completion at 10 months approximately
measure: Modifiable Risk Factor - Body Mass Index
timeFrame: baseline and through study completion at 10 months approximately
measure: Modifiable Risk Factor - Blood Pressure
timeFrame: baseline and through study completion at 10 months approximately
Other outcomes:
Locations:
city: Portage La Prairie
country: Canada
facility: Portage Clinic
state: Manitoba
Study officials:
References:
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