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Improving Hypertension Detection and Control Through a Hypertension Certification Program Based Upon the Hypertension Canada Guidelines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965104
Recruitment Status : Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : June 1, 2020
Sponsor:
Collaborator:
Hypertension Canada
Information provided by (Responsible Party):
Ross T. Tsuyuki, University of Alberta

Brief Summary:
This study will assess the impact of a hypertension management certification program for community pharmacists on the blood pressure control of patients managed by the pharmacists enrolled. The investigators will compare the systolic blood pressure of patients identified to have hypertension in the community that are followed by pharmacists who have undergone the certification course, and compare their blood pressure outcomes to subjects managed by pharmacists who have not yet received the training.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Hypertension Canada Professional Certification Program: HC-PCP Not Applicable

Detailed Description:

Hypertension Canada proposes the first "Hypertension Canada Professional Certification Program"(HC-PCP), specifically designed for Alberta pharmacists, to provide care and support to those at risk for or living with hypertension. Through this program, the investigators hope to help with prevention of the costly and chronic conditions to which hypertension often leads, like kidney failure, stroke, and heart disease.

The HC-PCP aims to provide training to pharmacists in the screening, prevention, and management of hypertension. It has been identified that the development and implementation of this certification program provides a unique opportunity to evaluate the impact of such a program on blood pressure reduction.

The investigators are aiming to assess the impact of pharmacist management on blood pressure control in patients with hypertension.

The development of the HC-PCP and the evaluation of its impact will occur in 2 phases. Phase 1 involves the development and implementation of the educational portion of the certification program. Phase 2 involves conducting a 1 year long study to assess the impact of the HC-PCP on blood pressure in patients with poorly controlled hypertension. This will be launched in pharmacies in Alberta.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Stepped wedge cluster randomized trial with the unit of randomization being the pharmacy
Masking: Single (Participant)
Masking Description: By necessity, pharmacists in the intervention groups cannot be blinded. However, pharmacists will not be told about the cluster randomization, just that they will be contacted about when they will receive the HC-PCP. During the control period, pharmacists will be told that their patients will be enrolled in an observational hypertension registry to prepare for the intervention phase.
Primary Purpose: Treatment
Official Title: Improving Hypertension Detection and Control Through a Hypertension Certification Program Based Upon the Hypertension Canada Guidelines (RxPATH)
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention pharmacists
Will receive the HC-PCP prior to starting enrollment, and then will provide care to their patients, which will include risk assessment, prescribing of antihypertensive medications, and follow-up monthly according to the Hypertension Canada Guidelines.
Behavioral: Hypertension Canada Professional Certification Program: HC-PCP
The HC-PCP is a certification program which aims to provide training to generalist primary care providers in the screening, prevention, and management of hypertension.The competencies assessed in the program have been validated for their importance through a national survey of hypertension experts and primary care providers.

No Intervention: Control pharmacists
Will provide usual pharmacist care. All patients with blood pressure above target will be entered into the study database and serve as the control group. No specific interventions or follow-up will be mandated other than usual pharmacist care, although all patients will be assessed at 3 months to determine change in BP since enrollment (the primary outcome).



Primary Outcome Measures :
  1. The difference in change in systolic blood pressure between Intervention and Control patients. [ Time Frame: From baseline to 3 month follow-up, and up to one year ]
    To detect a 7 millimeters of mercury (mmHg) or greater difference in systolic blood pressure.


Secondary Outcome Measures :
  1. Consultant Satisfaction Questionnaire [ Time Frame: 6 months following follow up ]
    patient satisfaction



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with poorly controlled blood pressure (>140/90mmHg or >130/80mmHg if they have diabetes).

Exclusion Criteria:

  • Unwilling to sign the consent form.
  • Unwilling to participate in follow up visits.
  • Current hypertension urgency or emergency (SBP > 180mmHg or DBP > 120mmHg).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965104


Contacts
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Contact: Ross Tsuyuki, PharmD 780 492 8526 Ross.Tsuyuki@ualberta.ca
Contact: Kaitlyn E Watson, PhD 780 492 3454 kewatson@ualberta.ca

Sponsors and Collaborators
University of Alberta
Hypertension Canada
Investigators
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Principal Investigator: Ross Tsuyuki, PharmD University of Alberta
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Responsible Party: Ross T. Tsuyuki, BSc (Pharm), PharmD, MSc, FCSHP, FACC, FCAHS, University of Alberta
ClinicalTrials.gov Identifier: NCT03965104    
Other Study ID Numbers: Pro00090012
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases