Implementation and Evaluation of a Pharmacist-led Diabetes Care Pathway in Alberta Community Pharmacies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
As of 2024, nine percent of Albertans are living with Type 2 diabetes, which increases their risk for cardiovascular disease, stroke, blindness, and kidney failure. Unfortunately, less than half of patients have controlled Type 2 diabetes. We are well aware of the factors which lead to worsening diabetes, but need to give people more support to help them manage their diabetes. Pharmacists are respected health care professionals who are often easier to see that doctors and can help people with diabetes to stay as healthy as possible.
This research project aims to see whether a pharmacist service can help improve diabetes management in people with type 2 diabetes compared to usual care from their family physician or nurse practitionner. The potential impact of this project is to empower people with type 2 diabetes to understand their condition, it's management, and to achieve target blood sugar levels, which will ultimately reduce the risk of diabetes-related complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18 years or older.
Individuals with type 2 diabetes.
Individuals with type 2 diabetes not reaching HbA1c target of under 7.0%
Disqualifiers
Individuals with type 1 diabetes, gestational diabetes, or other forms of diabetes that are not type 2 diabetes.
Pregnant individuals.
Individuals at their HbA1c target (HbA1c under 7.0%) or those with a limited life expectancy, frailty, or lack hypoglycemic awareness (i.e., those with an A1c target above 7.0%) .
Individuals unable to provide consent or who are unwilling to attend follow-up visits.
Trial design
Design model
Parallel
Treatments tested in this trial
Pharmacist-led diabetes care pathway
Other interventionarticipants in the intervention arm will receive the care using a shared decision-making pharmacist care pathway approach designed to guide type 2 diabetes management to achieve target A1C levels and reduce the risk of diabetes-related complications. The pharmacist care pathway is modelled after the Canadian Diabetes Association Guidelines22. This pathway (tool) will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to achieve target A1C levels and reduce the risk of diabetes-related complications. This will occur through follow-ups every 6 weeks for six months duration.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Pharmacist-led care pathwayExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
A1C change
The primary outcome is the difference in change in A1C calculated from baseline to the end of the study (up to six months) between the intervention and control groups.
Time frame
Up to 6 monthsSecondary outcomes
1
Estimated cardiovascular risk
The primary outcome is the difference in change in estimated CV risk from baseline to the end of the study (up to six months) between the intervention and control groups.
Time frame
Up to 6 months.2
Blood Pressure
The difference in change in blood pressure from baseline to the end of the study (up to six months) between the intervention and control groups.
Time frame
Up to 6 months.3
LDL cholesterol concentration
The difference in change in serum LDL-cholesterol concentration from baseline to the end of the study (up to six months) between the intervention and control groups
Time frame
Up to 6 months.4
Influenza vaccination
The difference in the proportion of participants who receive their influenza vaccination from baseline to the end of the study (up to six months) between the intervention and control groups.
Time frame
Up to 6 months.Sponsors and contacts
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Source ClinicalTrials.gov