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Behavioural Intervention

Pharmacist Intervention for Cardiovascular Disease Prevention (PRxOACT Trial)

N/A

Recruiting

Led By Yazid Al Hamarneh

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (18 years or older)

Be older than 18 years old

Must not have

Unwilling to participate/sign consent form

Unwilling or unable to participate in regular follow-up visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if pharmacists can help people reduce their risk of heart disease. Heart disease is a common and serious condition that causes a large number of deaths worldwide. The hope is that by

Who is the study for?

This trial is for adults over 18 with conditions like chronic kidney disease, diabetes, heart-related issues (atherosclerotic vascular disease), high blood pressure, obesity, tobacco or vape use, and chronic inflammatory diseases. It's not suitable for those who don't meet these criteria.

What is being tested?

The study tests a pharmacist-led care pathway to see if it can help reduce the risk of heart disease. Pharmacists will provide more frequent support to patients in managing their cardiovascular health.

What are the potential side effects?

Since this intervention involves guidance and lifestyle management rather than medication, direct side effects are minimal. However, changes in diet or exercise might cause discomfort initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not willing to sign the consent form.

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I cannot commit to regular follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Estimated cardiovascular risk

Secondary study objectives

A1c in those who have diabetes

Blood pressure

LDL Cholesterol Concentration

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pharmacist-led care pathwayExperimental Treatment1 Intervention

Participants in the intervention arm will receive the care using a shared decision-making pharmacist-led care pathway designed to guide the cardiovascular (CV) risk reduction process. The pharmacist-led care pathway is modelled after the largest CV risk reduction randomized controlled trial in a community pharmacy setting (RxEACH Study), and based upon the latest CV risk reduction guidelines, such as C-CHANGE. This pathway will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to calculate the participant's estimated CV risk. The participant and pharmacist will be guided by the care pathway to review the participant's estimated CV risk and contributing CV risk factors and engage in shared decision-making to manage the participant's CV risk factors using lifestyle changes and/or pharmacological treatment as clinically appropriate.

Group II: Usual CareActive Control1 Intervention

The control group will involve facilitated relay of information to participants' family physician. Participants in the control group will have their pharmacist collect information informing the patient's CV risk. Participants will then be given a letter that contains their values for CV risk factors (including blood pressure, HbA1c, and lipid panel), and they will be advised to present it to their family physician. No specific suggestions for CV risk reduction will be detailed in the letter. In the case where the patient does not have a family physician, they can be referred to a physician walk-in clinic. A follow-up appointment in 6-months' time will be booked for with all participants in the control group.

0 / 3Eligibility criteria met