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Completed

NCT Number: NCT00878566

Alberta Clinical Trial in Optimizing Hypertension

The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly controlled hypertension in the community setting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

About this study

The study is a randomized, controlled trial of enhanced pharmacist care, with the unit of randomization as the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up and prescribing/titration of antihypertensive medications or usual care. Participants will be patients in Alberta with undiagnosed or uncontrolled BP as defined by the Canadian Hypertension Education Program. The primary intervention will be enhanced pharmacist care. Pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing BP control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their BP. The primary outcome will be a comparison of difference in change in systolic BP between enhanced care and usual care at 24 weeks follow-up. Secondary outcomes include the number of patients at their BP target at 24 weeks, number of new antihypertensive medication starts, number of antihypertensive dosage changes, number of antihypertensive medication changes and number of new prescriptions for ASA and cholesterol medications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overall average (after 2 visits) systolic ≥180 OR diastolic ≥110 mmHg in undiagnosed patients without macrovascular target organ damage, diabetes or chronic kidney disease
  • Overall average (after 2 visits) systolic ≥140 OR diastolic ≥90 for patients with undiagnosed hypertension with macrovascular target organ damage (coronary artery disease, cerebrovascular disease, DM)
  • In patients with diagnosed hypertension, systolic ≥140 (≥ 130 with DM or CKD) OR diastolic ≥90, (≥ 80 with DM or CKD)
  • Overall average (after 5 visits, for those without macrovascular target organ damage, DM, or CKD and without an existing hypertension diagnosis) systolic ≥140 OR diastolic ≥90 mmHg
  • Overall average (after 7 days of twice-daily home blood pressure monitoring , for those without macrovascular target organ damage, DM, or CKD and without an existing hypertension diagnosis) systolic ≥135 OR diastolic ≥85

Exclusion criteria

  • Patients with hypertensive urgency or emergency:
  • Urgency: SBP ≥ 180 mm Hg or DBP ≥ 120 mm Hg with no acute signs of end-organ damage
  • Unwilling to participate/sign consent form
  • Pregnancy

Treatment and study plan

Enhanced pharmacist care

Other

The primary intervention will be enhanced pharmacist care. Pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing BP control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their BP. The pharmacist will also review the patient's current hypertensive therapy regimen and decide on the options for improvement of BP control (lifestyle modification, increase dose, additional BP medications), and implementation of these strategies.

Other names: Treatment group

Usual Care

Other

Patients randomized to usual care will receive a wallet card for BP readings, pamphlet on BP and usual pharmacist and physician care. Patients will be seen at 12 weeks for interim BP measurement only. Both groups of patients will be seen at 24 weeks for BP measurement.

Other names: Control

Primary outcomes

  1. Comparison of difference in change in systolic BP between enhanced care and usual care

    Time frame: 24 weeks

Secondary outcomes

  1. number of patients at their BP target

    Time frame: 24 weeks

  2. number of new antihypertensive medication starts

    Time frame: 24 weeks

  3. number of antihypertensive dosage changes

    Time frame: 24 weeks

  4. EQ-5D

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Alberta Clinical Trial in Optimizing Hypertension: The RxAction Study

Acronym: RxAction

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Apr 9, 2009
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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