The Effect of Pharmacist-Initiated Home Blood Pressure Monitoring on Blood Pressure Control in Women
HypertensionTo 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.
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Participation Requirements
-
Sex:
FEMALE -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
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
Exclusion Criteria:
* 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
Study Location
Hills Clinic Pharmacy
Hills Clinic PharmacyAylmer, Ontario
Canada
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Chris Sawler
Trailside Pharmacy Pharmasave
Trailside Pharmacy PharmasaveFergus, Ontario
Canada
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Lauren Thompson
Guardian MarkhaMack Pharmacy
Guardian MarkhaMack PharmacyMarkham, Ontario
Canada
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Ammar Haji
Lifecare Rx Pharmacy
Lifecare Rx PharmacyOakville, Ontario
Canada
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Jenny Cherian
Pharmasave Sally's Pharmacy
Pharmasave Sally's PharmacyOwen Sound, Ontario
Canada
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Sally Mina
Springwater Pharmacy
Springwater PharmacySpringwater, Ontario
Canada
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Shopper's Drug Mart #994
Shopper's Drug Mart #994Toronto, Ontario
Canada
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Shopper's Drug Mart #646
Shopper's Drug Mart #646Collingwood, Ontario
Canada
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Kawartha Lakes Pharmacy
Kawartha Lakes PharmacyLindsay, Ontario
Canada
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Joanna
Sav-ON IDA Pharmacy
Sav-ON IDA PharmacyOakville, Ontario
Canada
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Brisson Pharmacy
Brisson PharmacyOttawa, Ontario
Canada
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Sara Azad
Medicine Shopper #297
Medicine Shopper #297Scarborough, Ontario
Canada
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Shopper's Drug Mart #500
Shopper's Drug Mart #500Toronto, Ontario
Canada
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Eagle Ridge Pharmacy
Eagle Ridge PharmacyBarrie, Ontario
Canada
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HealthMax Pharmacy
HealthMax PharmacyHamilton, Ontario
Canada
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Zak's Pharmacy
Zak's PharmacyMilton, Ontario
Canada
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Noura Nakhla
9058752424Countryside Pharmacy
Countryside PharmacyOmemee, Ontario
Canada
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Sarah Holt
Kashyaps Pharmacy Peterborough
Kashyaps Pharmacy PeterboroughPeterborough, Ontario
Canada
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Raj Kashyap
Port Weller Pharmacy
Port Weller PharmacySt. Catherines, Ontario
Canada
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Ultima Apothecary
Ultima ApothecaryWindsor, Ontario
Canada
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Mcintyre IDA
Mcintyre IDABlenheim, Ontario
Canada
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Mac Jonker
Inverary Pharmasave
Inverary PharmasaveKingston, Ontario
Canada
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Leonard Chan
Custom Health Pharmacy
Custom Health PharmacyMississauga, Ontario
Canada
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Teresa Pitre
The Medicine Shoppe Pharmacy #143
The Medicine Shoppe Pharmacy #143Ottawa, Ontario
Canada
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Chantal Samaha
Hogan at the Bluewater Medical Clinic
Hogan at the Bluewater Medical ClinicSarnia, Ontario
Canada
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Health Care Pharmacy Pharmasave 683
Health Care Pharmacy Pharmasave 683Sudbury, Ontario
Canada
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- Study Sponsored By
- University of Alberta
- Participants Required
- More Information
- Study ID:
NCT05991414