Alberta Clinical Trial in Optimizing Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Enhanced pharmacist care; Other: Usual Care

• Registration Number: NCT00878566
• Lead Sponsor: University of Alberta

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.

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.

Study Timeline

• Study First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-08
• Study First Posted: 2009-04-09
• Study Start: 2009-11
• Primary Completion: 2013-11
• Study Completion: 2014-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-25
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced pharmacist care	Enhanced pharmacist care	-
Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Comparison of difference in change in systolic BP between enhanced care and usual care	24 weeks

Secondary Outcome Measures

Name	Time	Method
EQ-5D	24 weeks
number of patients at their BP target	24 weeks
number of new antihypertensive medication starts	24 weeks
number of antihypertensive dosage changes	24 weeks

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada