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Home Blood Pressure Monitoring for High Blood Pressure

N/A

Recruiting

Led By Ross Tsuyuki, PharmD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Established diagnosis or currently on treatment for hypertension.

No established diagnosis and/or treatment for hypertension.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate the effects of using home blood pressure monitoring in addition to pharmacist care compared to usual care in women with high blood pressure. The study will randomly assign participants to either receive the intervention

Who is the study for?

This trial is for women with high blood pressure who haven't been diagnosed or treated for hypertension, except those with diabetes where a lower BP threshold applies. Participants should have a systolic BP of at least 140 mmHg or diastolic BP of at least 90 mmHg, or at least 130/80 mmHg if diabetic.

What is being tested?

The study tests whether home blood pressure monitoring plus pharmacist care improves blood pressure control compared to usual pharmacist care alone in women. It's a randomized controlled trial where half the participants will use home monitors and get enhanced pharmacy services, while the other half receives standard care.

What are the potential side effects?

There are no direct side effects from participating in this trial as it involves non-invasive blood pressure monitoring and counseling by pharmacists rather than medication. However, there may be indirect effects such as anxiety from self-monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with or am being treated for high blood pressure.

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I have never been diagnosed or treated for high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in change in Systolic Blood Pressure

Secondary study objectives

Adherence to Medications

Changes to antihypertensive medication regimen

Consultant Satisfaction

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pharmacist care in conjunction with home blood pressure monitoringExperimental Treatment2 Interventions

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.

Group II: Usual pharmacist careActive Control1 Intervention

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.

0 / 2Eligibility criteria met