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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991414
• Other study ID #: Pro00128951
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: Daniel Burton, PharmD
• Phone: 403-510-7384
• Email: dburton[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Home blood pressure monitor
Participants provided home blood pressure monitor and instructions on use from pharmacist. They will measure home BP every 4-weeks for 7 days as per Hypertension Canada 7-day home BP protocol.

Procedure:
• Enhanced community pharmacist care
Pharmacist to follow up with participants every month to review home BP readings. Then the pharmacist will send home BP readings and recommendations for changes to antihypertensive medication regimen to participants prescribing clinician. Pharmacist will then advise participants to follow up with their prescribing clinician.
• Usual pharmacist care
Participants will come into the pharmacist at baseline, 12- and 24-weeks to have their BP taken by the pharmacist. Pharmacist will provide education and counseling. Pharmacist will send BP readings to participants prescribing clinician with no recommendations for changes to antihypertensive therapy. After 6-months participants will be offered a home BP monitor and instructions on use.

Locations

Country	Name	City	State
Canada	Hills Clinic Pharmacy	Aylmer	Ontario
Canada	Eagle Ridge Pharmacy	Barrie	Ontario
Canada	Mcintyre IDA	Blenheim	Ontario
Canada	Legend Pharmacy	Brantford	Ontario
Canada	Arrowhead Pharmacy	Cornwall	Ontario
Canada	Unicare Pharmacy	Etobicoke	Ontario
Canada	Trailside Pharmacy Pharmasave	Fergus	Ontario
Canada	Inverary Pharmasave	Kingston	Ontario
Canada	Kawartha Lakes Pharmacy	Lindsay	Ontario
Canada	Zak's Pharmacy	Milton	Ontario
Canada	Custom Health Pharmacy	Mississauga	Ontario
Canada	Unicare Pharmacy of Mississauga	Mississauga	Ontario
Canada	Lifecare Rx Pharmacy	Oakville	Ontario
Canada	Countryside Pharmacy	Omemee	Ontario
Canada	Brisson Pharmacy	Ottawa	Ontario
Canada	The Medicine Shoppe Pharmacy #143	Ottawa	Ontario
Canada	Pharmasave Sally's Pharmacy	Owen Sound	Ontario
Canada	Kashyaps Pharmacy Peterborough	Peterborough	Ontario
Canada	HealthSmart Pharmasave	Scarborough	Ontario
Canada	Springwater Pharmacy	Springwater	Ontario
Canada	Stouffville Pharmasave	Stouffville	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in change in Systolic Blood Pressure	Difference in change in Systolic Blood Pressure between the home blood pressure monitoring in addition to pharmacist care versus usual care group.	24-weeks
Secondary	Proportion at BP target	Proportion of patients at their BP target at 24-weeks, compared between intervention and control groups.	24-weeks
Secondary	Percentage of home blood pressure readings recorded	Percentage of HBPM readings input by patients in the intervention groups each month during the 7-Day BP Monitoring protocol. This will be reported as a percentage of the expected measurements which is 28 inputs each month.	24-weeks
Secondary	Adherence to Medications	Participants will be asked at each follow-up: Number of doses missed or forgotten between follow-up periods. The medication that the participant missed or forgot to take will be noted.	24-weeks
Secondary	Changes to antihypertensive medication regimen	Number of new antihypertensive medications that are initiated and compared between groups.; Number of antihypertensive medication changes and compared between groups. Number of antihypertensive dosage changes (increases or decreases) and compared between groups.	24-weeks
Secondary	Lifestyle changes	Number lifestyle changes made by a patient, such as increased activity, smoking cessation, self-reported weight-loss, reduced intake of salt and processed foods.	24-weeks
Secondary	Consultant Satisfaction	Patient's general satisfaction with pharmacist care measured by Consultant Satisfaction questionnaire and compared between groups.	24-weeks