Clinical trial NCT05991414: The Effect of Pharmacist-Initiated Home Blood Pressure Monitoring on Blood Pressure Control in Women
Official title: The Effect of Pharmacist-Initiated Home Blood Pressure Monitoring on Blood Pressure Control in Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 368
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants in Control Group will be offered opportunity to crossover to the Intervention Protocol after their initial 6-month study period.
Primary purpose: TREATMENT

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.

Detailed description: Purpose:

To determine the impact of home blood pressure monitoring when used in addition to pharmacist care, compared to usual care, in women with blood pressure elevated above their target level.

Hypothesis:

Women patients utilizing home blood pressure monitors and providing blood pressure readings to their community pharmacists who then provides tailored education to the patient and therapy recommendations to the patient's prescribing clinician will result in greater improvements in blood pressure control. In comparison to usual care.

Justification:

* Women are a target population for blood pressure control. A majority of women in Canada are not achieving their target blood pressure for optimal health outcomes.
* Home blood pressure monitors have demonstrated benefit in supporting patients in reaching their blood pressure targets, although they are under utilized.
* Community pharmacist care also has demonstrated benefit in supporting patients in reaching their blood pressure targets.
* Community pharmacies are where patients can acquire a home blood pressure monitor.

Research Method and Procedures:

Randomized Controlled Trial - Study length is 24-weeks with a final follow-up at 52-weeks.

Study Setting: Community Pharmacies throughout Ontario, Canada. Pharmacies will be selected identified and selected based on their location, using definitions of urban and rural communities from Statistics Canada's Statistical Area Classifications, and their willingness to partake in the study itself and follow-up with participants. The study is aiming to recruit a 50:50 ratio of pharmacies from urban and rural communities.

Screening/Case Finding:

Pharmacists may identify potential participants for screening via the following methods:

* During their usual workflow in providing patient care.
* During a hypertension screening day at the pharmacy.
* Searching patient pharmacy profiles with the following medication classes: Antidiabetes, antiobesity, antianginals, antihypertensive, cholesterol-lowering, smoking cessation therapies, prenatal vitamins or commonly used antihypertensives used during pregnancy such as methyldopa or labetalol.
* Referral from another healthcare provider.

Recruitment:

Once screening is complete if the participant is eligible for participation they will be asked by the pharmacist to provide consent. Consent will be obtained electronically via the REDCap database management system. Once consent is obtained the participant will be enrolled in the study and randomized to one of the two groups using the REDCap randomization module.

Both Groups:

* Pharmacist will measure participants blood pressure in the pharmacy using a standardized method based on the technique described by Hypertension Canada.
* Each participating pharmacy will be provided with a BIOS BD270 Automated Office Blood Pressure Monitor.
* Data to be collected by the pharmacist and input by the participant at baseline and week-24 includes demographics, medical history, medications, social history and cardiovascular risk factors.
* Participants prescribing clinician will be informed about the participants enrolment in the study.

Intervention Group:

* AOBP readings in the pharmacy will be taken at baseline and week-24.
* Participants will be provided with a BIOS BD240 home blood pressure monitor. Participants will measure their blood pressure at home every four weeks for five four week periods - they will take two consecutive BP readings in the morning and in the evening for a period of 7-days as per the Hypertension Canada 7-day BP Protocol. Participants will upload their data into the REDCap database via digital links sent via text message or email.
* Pharmacist will review BP readings with the participant at baseline and every 4 weeks. They will also send the BP readings along with suggestions for therapy modification to the participants prescribing clinician.
* After 24-weeks care is returned to the prescribing clinician and no further pharmacist specific interventions will be provided. The primary study will be complete at this point.
* After 52-weeks the pharmacist will complete a final follow-up to assess ongoing use of home blood pressure monitor and if there had been any further interactions with the prescribing clinician. No further follow-ups in regards to the study will occur beyond this point.

Control Group:

* AOBP readings in the pharmacy will be taken at baseline, week-12 and week-24.
* Participants will not be provided with a home blood pressure monitor.
* Pharmacists will review BP readings with the participant at each follow up and they will send BP readings to the participants prescribing clinician. The pharmacist will provide no recommendations for therapy modification.
* After the week-24 follow up participants will be offered a BIOS BD240 home blood pressure monitor. They will also be offered the opportunity to crossover to the intervention group for the next 24-weeks. If the participant agrees to crossover they will receive the full intervention protocol with the exception of the final follow-up at week-52. If they decline to crossover care is returned to the prescribing clinician and no further pharmacist specific interventions will be provided. The primary study will be complete at this point. After 52-weeks the pharmacist will complete a final follow-up to assess ongoing use of home blood pressure monitor and if there had been any further interactions with the prescribing clinician. No further follow-ups in regards to the study will occur beyond this point.

Sample Size:

Calculated to be 320 participants to achieve 80% power. This assumes an estimated SD of 13.5 to detect a difference in change of AOBP Systolic Blood Pressure of 4.5mmHg. We have assumed a drop-out or loss to follow up rate of 15% which increases our sample size to 368 participants with 184 participants in each group.

Plan for Data Analysis:

Data will be collected in the RedCap Database. Data will be analyzed in conjunction with the ABSPOR Unit who is providing the support for data analysis, interpretation and data visualization.

Eligibility 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

Primary outcomes:
measure: Difference in change in Systolic Blood Pressure
timeFrame: 24-weeks
Secondary outcomes:
measure: Proportion at BP target
timeFrame: 24-weeks
measure: Percentage of home blood pressure readings recorded
timeFrame: 24-weeks
measure: Adherence to Medications
timeFrame: 24-weeks
measure: Changes to antihypertensive medication regimen
timeFrame: 24-weeks
measure: Lifestyle changes
timeFrame: 24-weeks
measure: Consultant Satisfaction
timeFrame: 24-weeks
Other outcomes:
Locations:
city: Aylmer
country: Canada
facility: Hills Clinic Pharmacy
state: Ontario
city: Barrie
country: Canada
facility: Eagle Ridge Pharmacy
state: Ontario
city: Blenheim
country: Canada
facility: Mcintyre IDA
state: Ontario
city: Collingwood
country: Canada
facility: Shopper's Drug Mart #646
state: Ontario
city: Fergus
country: Canada
facility: Trailside Pharmacy Pharmasave
state: Ontario
city: Hamilton
country: Canada
facility: HealthMax Pharmacy
state: Ontario
city: Kingston
country: Canada
facility: Inverary Pharmasave
state: Ontario
city: Lindsay
country: Canada
facility: Kawartha Lakes Pharmacy
state: Ontario
city: Markham
country: Canada
facility: Guardian MarkhaMack Pharmacy
state: Ontario
city: Milton
country: Canada
facility: Zak's Pharmacy
state: Ontario
city: Mississauga
country: Canada
facility: Custom Health Pharmacy
state: Ontario
city: Oakville
country: Canada
facility: Sav-ON IDA Pharmacy
state: Ontario
city: Oakville
country: Canada
facility: Lifecare Rx Pharmacy
state: Ontario
city: Omemee
country: Canada
facility: Countryside Pharmacy
state: Ontario
city: Ottawa
country: Canada
facility: The Medicine Shoppe Pharmacy #143
state: Ontario
city: Ottawa
country: Canada
facility: Brisson Pharmacy
state: Ontario
city: Owen Sound
country: Canada
facility: Pharmasave Sally's Pharmacy
state: Ontario
city: Peterborough
country: Canada
facility: Kashyaps Pharmacy Peterborough
state: Ontario
city: Sarnia
country: Canada
facility: Hogan at the Bluewater Medical Clinic
state: Ontario
city: Scarborough
country: Canada
facility: Medicine Shopper #297
state: Ontario
city: Springwater
country: Canada
facility: Springwater Pharmacy
state: Ontario
city: St. Catherines
country: Canada
facility: Port Weller Pharmacy
state: Ontario
city: Sudbury
country: Canada
facility: Health Care Pharmacy Pharmasave 683
state: Ontario
city: Toronto
country: Canada
facility: Shopper's Drug Mart #500
state: Ontario
city: Toronto
country: Canada
facility: Shopper's Drug Mart #994
state: Ontario
city: Windsor
country: Canada
facility: Ultima Apothecary
state: Ontario
Study officials:
affiliation: University of Alberta
name: Ross Tsuyuki, PharmD
role: PRINCIPAL_INVESTIGATOR
References: