The Effect of Pharmacist-Initiated Home Blood Pressure Monitoring on Blood Pressure Control in Women

Summary

To evaluate the impact of home blood pressure monitoring when used in addition to pharmacist care, compared to usual care, in women with elevated blood pressure (BP). Randomized 1:1 two-arm controlled trial. Patients to be identified and screened by pharmacists. Patients with a BP \>140/90mmHg or \>130/80mmHg in those with diabetes will be invited to enroll in the study.

Intervention: Patients will have BP assessed at baseline by the pharmacist, and they will receive a home blood pressure monitor in addition to counselling provided by the pharmacist. Patients will measure their BP at home for seven days every four weeks and input their results into a data management system. The pharmacist will follow up with the patient every 4 weeks to review their readings and at 24-weeks the patient will come into the pharmacy for a final follow-up and BP readings. The pharmacist will fax BP readings and suggestions for therapy modification to the patient's prescribing clinician. After 24-weeks patient care is returned to the prescribing clinician with no further pharmacist interventions except for a final post-trial follow-up at week-52 to review ongoing home BP monitor use and BP management by the prescribing clinician.

Control: Patients will have BP assessed at baseline, 12-, and 24-weeks in the pharmacy by the pharmacist. Patients will not receive a home blood pressure monitor. Pharmacist will provide usual care, education and counselling on BP management. Pharmacists will fax BP readings to the patient's prescribing clinician but will not provide any suggestions for therapy modification. After 24-weeks patients will be offered a home blood pressure monitor with education on its use. They will then be offered to crossover to the intervention group for the next 24-weeks or have their care returned to their prescribing clinician with no pharmacist specific interventions except for a final post-trial follow-up at week-52 to review ongoing home BP monitor use and BP management by the prescribing clinician.

Sample Size: Calculated sample size is 368 participants to achieve 80% power, with 184 patients in the intervention and control groups.

Primary Outcome: Difference in change in Systolic Blood Pressure between the home blood pressure monitoring in addition to pharmacist care versus usual care group.

Conditions

• Hypertension

Interventions

DEVICE

Home blood pressure monitor

Participants provided home blood pressure monitor and instructions on use from pharmacist. They will measure home BP every 4-weeks for 7 days as per Hypertension Canada 7-day home BP protocol.

PROCEDURE

Enhanced community pharmacist care

Pharmacist to follow up with participants every month to review home BP readings. Then the pharmacist will send home BP readings and recommendations for changes to antihypertensive medication regimen to participants prescribing clinician. Pharmacist will then advise participants to follow up with their prescribing clinician.

PROCEDURE

Usual pharmacist care

Participants will come into the pharmacist at baseline, 12- and 24-weeks to have their BP taken by the pharmacist. Pharmacist will provide education and counseling. Pharmacist will send BP readings to participants prescribing clinician with no recommendations for changes to antihypertensive therapy. After 6-months participants will be offered a home BP monitor and instructions on use.

Sponsors & Collaborators

• University of Alberta

  lead OTHER

Principal Investigators

• Ross Tsuyuki, PharmD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-09

Primary Completion

2026-01-31

Completion

2026-06-30

Countries

• Canada

Study Locations