Alberta Clinical Trial in Optimizing Hypertension (RxAction)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Alberta.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ross T. Tsuyuki, University of Alberta
ClinicalTrials.gov Identifier:
NCT00878566
First received: April 8, 2009
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Hypertension
Other: Enhanced pharmacist care
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Alberta Clinical Trial in Optimizing Hypertension: The RxAction Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Comparison of difference in change in systolic BP between enhanced care and usual care [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of patients at their BP target [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • number of new antihypertensive medication starts [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • number of antihypertensive dosage changes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: November 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care Other: Usual Care
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 Name: Control
Experimental: Enhanced pharmacist care Other: Enhanced pharmacist care
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 Name: Treatment group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Overall average (after 2 visits) systolic ≥180 OR diastolic ≥110 mmHg in undiagnosed patients without macrovascular target organ damage, diabetes or chronic kidney disease
  2. 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)
  3. In patients with diagnosed hypertension, systolic ≥140 (≥ 130 with DM or CKD) OR diastolic ≥90, (≥ 80 with DM or CKD)
  4. 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
  5. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878566

Contacts
Contact: Meagen Rosenthal, MA 780.492.8350 meagen@ualberta.ca
Contact: Ross T. Tsuyuki, PharmD, MSc 780.492.8526 ross.tsuyuki@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Ross T. Tsuyuki, PharmD, MSc University of Alberta
  More Information

No publications provided

Responsible Party: Ross T. Tsuyuki, Dr., University of Alberta
ClinicalTrials.gov Identifier: NCT00878566     History of Changes
Other Study ID Numbers: Pro00005300
Study First Received: April 8, 2009
Last Updated: April 18, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
hypertension
pharmacists
rural health
prescribing

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014