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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Canada
Hills Clinic Pharmacy
RECRUITING
Aylmer
Eagle Ridge Pharmacy
RECRUITING
Barrie
Mcintyre IDA
RECRUITING
Blenheim
Shopper's Drug Mart #646
RECRUITING
Collingwood
Trailside Pharmacy Pharmasave
RECRUITING
Fergus
Health Care Pharmacy Pharmasave 683
RECRUITING
Greater Sudbury
HealthMax Pharmacy
RECRUITING
Hamilton
Inverary Pharmasave
RECRUITING
Kingston
Kawartha Lakes Pharmacy
RECRUITING
Lindsay
Guardian MarkhaMack Pharmacy
RECRUITING
Markham
Zak's Pharmacy
RECRUITING
Milton
Custom Health Pharmacy
RECRUITING
Mississauga
Lifecare Rx Pharmacy
RECRUITING
Oakville
Sav-ON IDA Pharmacy
RECRUITING
Oakville
Countryside Pharmacy
RECRUITING
Omemee
Brisson Pharmacy
RECRUITING
Ottawa
The Medicine Shoppe Pharmacy #143
RECRUITING
Ottawa
Pharmasave Sally's Pharmacy
RECRUITING
Owen Sound
Kashyaps Pharmacy Peterborough
RECRUITING
Peterborough
Port Weller Pharmacy
RECRUITING
Saint Catherines
Hogan at the Bluewater Medical Clinic
RECRUITING
Sarnia
Medicine Shopper #297
RECRUITING
Scarborough Village
Springwater Pharmacy
RECRUITING
Springwater
Shopper's Drug Mart #500
RECRUITING
Toronto
Shopper's Drug Mart #994
RECRUITING
Toronto
Ultima Apothecary
RECRUITING
Windsor
Contact Information
Primary
Daniel Burton, PharmD
dburton@ualberta.ca
403-510-7384
Backup
Ross Tsuyuki, PharmD
rtsuyuki@ualberta.ca
780-492-8526
Time Frame
Start Date: 2024-01-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 368
Treatments
Experimental: Pharmacist care in conjunction with home blood pressure monitoring
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.
Active_comparator: Usual pharmacist care
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.
Related Therapeutic Areas
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov