NCT00878566

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

April 8, 2009

Last Update Submit

April 25, 2015

Conditions

Hypertension

Keywords

hypertensionpharmacistsrural healthprescribing

Outcome Measures

Primary Outcomes (1)

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

    24 weeks

Secondary Outcomes (4)

  • number of patients at their BP target

    24 weeks

  • number of new antihypertensive medication starts

    24 weeks

  • number of antihypertensive dosage changes

    24 weeks

  • EQ-5D

    24 weeks

Study Arms (2)

Usual Care

ACTIVE COMPARATOR
Other: Usual Care

Enhanced pharmacist care

EXPERIMENTAL
Other: Enhanced pharmacist care

Interventions

Enhanced pharmacist careOTHER

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.

Also known as: Treatment group
Enhanced pharmacist care
Usual CareOTHER

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.

Also known as: Control
Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

Related Publications (2)

  • Tsuyuki RT, Houle SK, Charrois TL, Kolber MR, Rosenthal MM, Lewanczuk R, Campbell NR, Cooney D, McAlister FA; RxACTION Investigators*. Randomized Trial of the Effect of Pharmacist Prescribing on Improving Blood Pressure in the Community: The Alberta Clinical Trial in Optimizing Hypertension (RxACTION). Circulation. 2015 Jul 14;132(2):93-100. doi: 10.1161/CIRCULATIONAHA.115.015464. Epub 2015 Jun 10.

    PMID: 26063762DERIVED

  • Charrois TL, McAlister FA, Cooney D, Lewanczuk R, Kolber MR, Campbell NR, Rosenthal M, Houle SK, Tsuyuki RT. Improving hypertension management through pharmacist prescribing; the rural Alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods. Implement Sci. 2011 Aug 11;6:94. doi: 10.1186/1748-5908-6-94.

    PMID: 21834970DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ross T. Tsuyuki, PharmD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2013

Study Completion

March 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

CA(1)