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

NCT05991414 | Active Not Recruiting

• 1 other identifier: Pro00128951
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 26

Brief 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

Outcome Measures

Primary Outcomes (1)

• Difference in change in Systolic Blood Pressure

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

  24-weeks

Secondary Outcomes (6)

• Proportion at BP target

  24-weeks

• Percentage of home blood pressure readings recorded

  24-weeks

• Adherence to Medications

  24-weeks

• Changes to antihypertensive medication regimen

  24-weeks

• Lifestyle changes

  24-weeks

Study Arms (2)

Pharmacist care in conjunction with home blood pressure monitoring

EXPERIMENTAL

Patients will have BP assessed at baseline in the pharmacy by the pharmacist, and they will receive a home blood pressure monitor in addition to education and 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 called REDCap that is accessible by the pharmacist. 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 as well as suggestions for therapy modification to the patient's prescribing clinician. Patients will then have their care returned to their prescribing clinician with no pharmacist specific interventions outside of usual pharmacy care activities and have a single follow-up at month-12 with the pharmacist reviewing home BP monitor use and reporting of data to prescribing clinician.

Device: Home blood pressure monitor; Procedure: Enhanced community pharmacist care

Usual pharmacist care

ACTIVE COMPARATOR

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 them 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 6-months or have their care returned to their prescribing clinician with no pharmacist specific interventions outside of usual pharmacy care activities and have a single follow-up at month-12 with the pharmacist reviewing home BP monitor use and reporting of data to prescribing clinician.

Procedure: Usual pharmacist care

Interventions

Enhanced community pharmacist care PROCEDURE

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.

Pharmacist care in conjunction with home blood pressure monitoring

Usual pharmacist care PROCEDURE

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.

Usual pharmacist care

Home blood pressure monitor DEVICE

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.

Pharmacist care in conjunction with home blood pressure monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included if they are female ≥18 years of age and meet one of the following criteria:
• No established diagnosis and/or treatment for hypertension.
• Average of three AOBP readings at two pharmacy visits within a 2-week period:
• SBP ≥140 mmHg or DBP ≥90 mmHg
• SBP ≥130 mmHg or DBP ≥80 mmHg if they have diabetes
• Established diagnosis or currently on treatment for hypertension.
• Average of three AOBP readings from one pharmacy visit:
• SBP ≥140mmHg or DBP ≥90mmHg
• SBP ≥130mmHg or DBP ≥80mmHg if they have diabetes

You may not qualify if:

• Male
• Having hypertensive urgency or emergency as determined on screening defined as (these patients will be referred to urgent care):
• Severe elevation of SBP \>180mmHg and/or DBP \>120mmHg
• Taking oral contraceptives
• Arm that \<24cm (9.4") or an arm that is \>43cm (17")
• Currently have, or are using a home blood pressure monitor
• No access to a smartphone or internet
• Unwilling or unable to participate or provide informed consent and sign the consent form
• If the patient is pregnant
• Participating or planning to participate in another research study or project

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (26)

Hills Clinic Pharmacy

Aylmer, Ontario, N5H1K9, Canada

Location

Eagle Ridge Pharmacy

Barrie, Ontario, L4N6M2, Canada

Location

Mcintyre IDA

Blenheim, Ontario, N0P1A0, Canada

Location

Shopper's Drug Mart #646

Collingwood, Ontario, L9Y1A5, Canada

Location

Trailside Pharmacy Pharmasave

Fergus, Ontario, N1M2W3, Canada

Location

Health Care Pharmacy Pharmasave 683

Greater Sudbury, Ontario, P3A1Y8, Canada

Location

HealthMax Pharmacy

Hamilton, Ontario, L8P1A1, Canada

Location

Inverary Pharmasave

Kingston, Ontario, K0H1X0, Canada

Location

Kawartha Lakes Pharmacy

Lindsay, Ontario, K9V5B7, Canada

Location

Guardian MarkhaMack Pharmacy

Markham, Ontario, L6E0B7, Canada

Location

Zak's Pharmacy

Milton, Ontario, L9T1N3, Canada

Location

Custom Health Pharmacy

Mississauga, Ontario, L5L6A8, Canada

Location

Sav-ON IDA Pharmacy

Oakville, Ontario, L6H0X9, Canada

Location

Lifecare Rx Pharmacy

Oakville, Ontario, L6H3S7, Canada

Location

Countryside Pharmacy

Omemee, Ontario, K0L2W0, Canada

Location

The Medicine Shoppe Pharmacy #143

Ottawa, Ontario, K1J9M1, Canada

Location

Brisson Pharmacy

Ottawa, Ontario, K1N9M1, Canada

Location

Pharmasave Sally's Pharmacy

Owen Sound, Ontario, N4K5N3, Canada

Location

Kashyaps Pharmacy Peterborough

Peterborough, Ontario, K9J1Z9, Canada

Location

Port Weller Pharmacy

Saint Catherines, Ontario, L2M7R4, Canada

Location

Hogan at the Bluewater Medical Clinic

Sarnia, Ontario, N7T4X3, Canada

Location

Medicine Shopper #297

Scarborough Village, Ontario, M1B4Y7, Canada

Location

Springwater Pharmacy

Springwater, Ontario, L9X0V7, Canada

Location

Shopper's Drug Mart #500

Toronto, Ontario, M4C1H6, Canada

Location

Shopper's Drug Mart #994

Toronto, Ontario, M4J1L2, Canada

Location

Ultima Apothecary

Windsor, Ontario, N8X3X5, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ross Tsuyuki, PharmD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in Control Group will be offered opportunity to crossover to the Intervention Protocol after their initial 6-month study period.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 14, 2023
• Study Start: January 9, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (26)