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Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes

Primary Purpose

Diabetes Type 2

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Behavioral and drugs already approved and available for diabetes management
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients whose primary care physician is within the Portage Clinic
  • Adults (age 18 and older) with type 2 diabetes with HgA1C above 10 %
  • 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 HgA1C 10 % or less
  • Patients whom refuse medication adjustments
  • Patients with severe renal impairment or receiving dialysis treatments

Sites / Locations

  • Portage Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Arm

Pharmacist Intervention Arm

Arm Description

The participants in this arm will receive standard of care from their physician as they would have been doing previously. This still may involve blood work, referrals to other health providers (except pharmacist) and medication adjustments driven by the pharmacist.

The participants in this arm will receive standard of care from their physician in addition to pharmacist intervention. The pharmacist or pharmD intern leads the diabetes care for the patient typically, conducting a medication review, recommending medication changes, frequent follow up and requesting blood work and providing referrals to other health care providers as needed,which is standard care

Outcomes

Primary Outcome Measures

Change in Baseline Hemoglobin A1C (HbA1C) at 10 months
Measure of blood glucose control at the lab

Secondary Outcome Measures

Participant Survey
Evaluating the patients knowledge of diabetes management, comfort with managing their own diabetes care, perception of the pharmacist's role
Modifiable Risk Factors -Cholesterol Level
evaluating changes in modifiable risk factors such as cholesterol levels reported in mmol/L
Modifiable Risk Factor - Body Mass Index
evaluating changes in modifiable risk factors such as weight and height which will be combined to report body mass index in kg/m^2
Modifiable Risk Factor - Blood Pressure
evaluating changes in modifiable risk factors such as blood pressure reported in mmHg

Full Information

First Posted
June 20, 2022
Last Updated
October 18, 2023
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT05442840
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to 1 of 2 arms, either control or pharmacist intervention
Masking
Care Provider
Masking Description
The care provider (physician) will be aware the patient is participating in the study but will not be informed directly as to which arm they will be enrolled in, however if they review the electronic chart record they will be able to identify which arm
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The participants in this arm will receive standard of care from their physician as they would have been doing previously. This still may involve blood work, referrals to other health providers (except pharmacist) and medication adjustments driven by the pharmacist.
Arm Title
Pharmacist Intervention Arm
Arm Type
Active Comparator
Arm Description
The participants in this arm will receive standard of care from their physician in addition to pharmacist intervention. The pharmacist or pharmD intern leads the diabetes care for the patient typically, conducting a medication review, recommending medication changes, frequent follow up and requesting blood work and providing referrals to other health care providers as needed,which is standard care
Intervention Type
Combination Product
Intervention Name(s)
Behavioral and drugs already approved and available for diabetes management
Intervention Description
Pharmacists will review the patients information and medical history as well as drug coverage to discuss preferred treatment options to manage diabetes based on recommendations from Diabetes Canada treatment guidelines; all drugs have been approved and are available on the market; pharmacists will offer frequent follow up and provide basic diabetes education to the patient at each follow up appointment
Primary Outcome Measure Information:
Title
Change in Baseline Hemoglobin A1C (HbA1C) at 10 months
Description
Measure of blood glucose control at the lab
Time Frame
baseline and through study completion at 10 months approximately
Secondary Outcome Measure Information:
Title
Participant Survey
Description
Evaluating the patients knowledge of diabetes management, comfort with managing their own diabetes care, perception of the pharmacist's role
Time Frame
baseline and through study completion at 10 months approximately
Title
Modifiable Risk Factors -Cholesterol Level
Description
evaluating changes in modifiable risk factors such as cholesterol levels reported in mmol/L
Time Frame
baseline and through study completion at 10 months approximately
Title
Modifiable Risk Factor - Body Mass Index
Description
evaluating changes in modifiable risk factors such as weight and height which will be combined to report body mass index in kg/m^2
Time Frame
baseline and through study completion at 10 months approximately
Title
Modifiable Risk Factor - Blood Pressure
Description
evaluating changes in modifiable risk factors such as blood pressure reported in mmHg
Time Frame
baseline and through study completion at 10 months approximately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Portage Clinic
City
Portage La Prairie
State/Province
Manitoba
ZIP/Postal Code
R1N 3V5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes

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