The Effect of Pharmacist-Initiated Home Blood Pressure Monitoring on Blood Pressure Control in Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 368
- 试验地点
- 26
- 主要终点
- Difference in change in Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pharmacist care in conjunction with home blood pressure monitoring
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.
干预措施: Enhanced community pharmacist care (Procedure)
Usual pharmacist care
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.
干预措施: Usual pharmacist care (Procedure)
Pharmacist care in conjunction with home blood pressure monitoring
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.
干预措施: Home blood pressure monitor (Device)
结局指标
主要结局
Difference in change in Systolic Blood Pressure
时间窗: 24-weeks
Difference in change in Systolic Blood Pressure between the home blood pressure monitoring in addition to pharmacist care versus usual care group.
次要结局
- Adherence to Medications(24-weeks)
- Proportion at BP target(24-weeks)
- Percentage of home blood pressure readings recorded(24-weeks)
- Changes to antihypertensive medication regimen(24-weeks)
- Lifestyle changes(24-weeks)
- Consultant Satisfaction(24-weeks)