Home Blood Pressure Monitoring for High Blood Pressure
Recruiting in Palo Alto (17 mi)
+31 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Must not be taking: Oral contraceptives
Disqualifiers: Male, Hypertensive emergency, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment, as the study involves monitoring blood pressure and pharmacist care.
What data supports the effectiveness of the treatment Enhanced community pharmacist care for high blood pressure?
Research shows that involving community pharmacists in home blood pressure monitoring can improve blood pressure control and medication adherence. Studies indicate that this approach, especially when combined with telemonitoring, enhances the relationship between patients and healthcare providers, leading to better management of high blood pressure.
12345Is home blood pressure monitoring safe for humans?
Home blood pressure monitoring, often involving pharmacists, is generally considered safe for humans. Studies have shown that it can improve blood pressure control and enhance the relationship between patients and healthcare providers without indicating any specific safety concerns.
12356How is the treatment 'Enhanced community pharmacist care with home blood pressure monitoring' different from other treatments for high blood pressure?
This treatment is unique because it involves a team-based approach where community pharmacists play a key role in managing high blood pressure through home monitoring and telemonitoring systems. This collaborative model enhances patient care by providing personalized and preventive management, which can improve blood pressure control and patient adherence compared to standard care.
12367Eligibility Criteria
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.Inclusion Criteria
I have been diagnosed with or am being treated for high blood pressure.
I have never been diagnosed or treated for high blood pressure.
If you have diabetes, your Systolic Blood Pressure (SBP) must be at least 130 mmHg and/or Diastolic Blood Pressure (DBP) must be 80 mmHg or greater.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive pharmacist care with home blood pressure monitoring or usual care for 24 weeks
24 weeks
Baseline, every 4 weeks, and final follow-up at 24 weeks
Follow-up
Participants are monitored for ongoing use of home blood pressure monitor and BP management by the prescribing clinician
28 weeks
Final follow-up at 52 weeks
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Shopper's Drug Mart #646Collingwood, Canada
HealthMax PharmacyHamilton, Canada
Guardian MarkhaMack PharmacyMarkham, Canada
Sav-ON IDA PharmacyOakville, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). [2022]To evaluate the effectiveness of a community pharmacist-based home blood pressure (BP) monitoring program.
The pharmacist and the management of arterial hypertension: the role of blood pressure monitoring and telemonitoring. [2020]Randomized controlled trials have documented that a team of health care professionals which includes a physician, a nurse and a community pharmacist may improve the benefit and adherence of anti-hypertensive therapy. If such a health care model relies on blood pressure telemonitoring, it can promote a stronger relationship between health care professionals and patients, and further improve BP control of hypertension. The major benefit of this collaborative approach is to center the patient's management in a tailored way, providing comprehensive and preventive care based on health information technologies. In this review, the authors summarize recent clinical studies that evaluate the role of the community pharmacist in BP measurements, and in hypertension screening and control. The authors also describe the advantages of using blood pressure telemonitoring in home and ambulatory settings to evaluate potential alternatives to primary care in hypertension management.
Economic Evaluation of the Home Blood Pressure Telemonitoring and Pharmacist Case Management to Control Hypertension (Hyperlink) Trial. [2022]Pharmacist-managed (team-based) care for hypertension with home blood pressure monitoring support interventions have been widely studied and shown to be effective in improving rates of hypertension control and lowering blood pressure; however, few studies have evaluated the economic considerations related to bringing these programs into usual practice.
Home blood pressure monitoring and adherence in patients with hypertension on primary prevention treatment: a survey of 1026 patients in general medicine in the Auvergne region. [2022]Home blood pressure monitoring (HBPM) could improve blood pressure control through therapeutic adherence. The main objective of this study was to determine the link between HBPM used by hypertensive patients treated in primary care and their medication adherence.
Accuracy of community-based blood pressure devices versus validated self-use devices. [2015]To examine the accuracy of a community-based blood pressure monitor (CBPM) versus a validated automatic blood pressure monitor (ABPM); to assess providers' recommendations regarding use of CBPMs; and to assess if potentially inaccurate blood pressure readings may result in treatment changes.
Team-based home blood pressure monitoring for blood pressure equity a protocol for a stepped wedge cluster randomized trial. [2023]Home Blood Pressure Monitoring (HBPM) that includes a team with a clinical pharmacist is an evidence-based intervention that improves blood pressure (BP). Yet, strategies for promoting its adoption in primary care are lacking. We developed potentially feasible and sustainable implementation strategies to improve hypertension control and BP equity.
Use of pharmacist blood pressure telemonitoring systems in diagnosis of nocturnal hypertension in a young healthy male. [2021]Blood pressure (BP) telemonitoring systems and pharmacist management programs were introduced into Haruka Community Pharmacy. A 22-year-old healthy male came to the community pharmacy, although he was not in a diseased state, he had been informed previously that he had a moderately high BP during a routine examination. He continued home BP telemonitoring for 28 days. A pharmacist intervention was conducted at 2 week intervals. His average nighttime systolic BP was higher than the daytime systolic BP. The pharmacist consulted a doctor based on the BP telemonitoring results, and ambulatory blood pressure monitoring (ABPM) was initiated. The doctor detected nocturnal hypertension based on the results of ABPM monitoring. BP telemonitoring systems have been introduced into a small percentage of pharmacies in Japan, and this is the first case report for the usefulness of these systems in a community pharmacy.