The Effect of Pharmacist-Initiated Home Blood Pressure Monitoring on Blood Pressure Control in Women (NCT05991414)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Hills Clinic Pharmacy โ Aylmer, Ontario
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- Hills Clinic Pharmacy โ Aylmer, Ontario
- Eagle Ridge Pharmacy โ Barrie, Ontario
- Mcintyre IDA โ Blenheim, Ontario
- Shopper's Drug Mart #646 โ Collingwood, Ontario
- Trailside Pharmacy Pharmasave โ Fergus, Ontario
- Health Care Pharmacy Pharmasave 683 โ Greater Sudbury, Ontario
- HealthMax Pharmacy โ Hamilton, Ontario
- Inverary Pharmasave โ Kingston, Ontario
- Kawartha Lakes Pharmacy โ Lindsay, Ontario
- Guardian MarkhaMack Pharmacy โ Markham, Ontario
- Zak's Pharmacy โ Milton, Ontario
- Custom Health Pharmacy โ Mississauga, Ontario
- Sav-ON IDA Pharmacy โ Oakville, Ontario
- Lifecare Rx Pharmacy โ Oakville, Ontario
- Countryside Pharmacy โ Omemee, Ontario
- The Medicine Shoppe Pharmacy #143 โ Ottawa, Ontario
- Brisson Pharmacy โ Ottawa, Ontario
- Pharmasave Sally's Pharmacy โ Owen Sound, Ontario
- Kashyaps Pharmacy Peterborough โ Peterborough, Ontario
- Port Weller Pharmacy โ Saint Catherines, Ontario
- Hogan at the Bluewater Medical Clinic โ Sarnia, Ontario
- Medicine Shopper #297 โ Scarborough Village, Ontario
- Springwater Pharmacy โ Springwater, Ontario
- Shopper's Drug Mart #500 โ Toronto, Ontario
- Shopper's Drug Mart #994 โ Toronto, Ontario
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.