HypertensionNCT03965104
Improving Hypertension Detection and Control Through a Hypertension Certification Program Based Upon the Hypertension Canada Guidelines
A study testing Hypertension Canada Professional Certification Program: HC-PCP in people with Hypertension, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Hypertension Canada Professional Certification Program: HC-PCP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 890 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2020to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with poorly controlled blood pressure (>140/90mmHg or >130/80mmHg if they have diabetes).
Who cannot join
- Unwilling to sign the consent form.
- Unwilling to participate in follow up visits.
- Current hypertension urgency or emergency (SBP > 180mmHg or DBP > 120mmHg).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Hypertension Detection and Control Through a Hypertension Certification Program Based Upon the Hypertension Canada Guidelines (RxPATH)
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Hypertension Canada Professional Certification Program: HC-PCP
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertension Canada Professional Certification Program: HC-PCPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention pharmacists | Experimental | 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. Receives: Behavioral: Hypertension Canada Professional Certification Program: HC-PCP |
| Control pharmacists | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in change in systolic blood pressure between Intervention and Control patients.
To detect a 7 millimeters of mercury (mmHg) or greater difference in systolic blood pressure.
Measured: From baseline to 3 month follow-up, and up to one year
Secondary outcomes (1)
Consultant Satisfaction Questionnaire
patient satisfaction
Measured: 6 months following follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start15 Sep 2020
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Stepped wedge cluster randomized trial with the unit of randomization being the pharmacy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Hypertension Canada
- Responsible party
- Sponsor
- Investigators
- Ross Tsuyuki, PharmD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965104
- Sponsor's protocol ID
- Pro00090012
- Status last verified
- Jan 2023
- First submitted
- 23 May 2019
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hypertension Detection and Control Through a Hypertension Certification Program Based Upon the Hypertension Canada Guidelines (RxPATH)
- ClinicalTrials.gov ID
- NCT03965104
- Acronym / sponsor ID
- Pro00090012
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Hypertension Canada
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial with the unit of randomization being the pharmacy
| Arm | Type | Receives |
|---|---|---|
| Intervention pharmacists | Experimental | Behavioral: Hypertension Canada Professional Certification Program: HC-PCPWill 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. |
| Control pharmacists | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with poorly controlled blood pressure (>140/90mmHg or >130/80mmHg if they have diabetes).
Key exclusion criteria (3 listed)
- Unwilling to sign the consent form.
- Unwilling to participate in follow up visits.
- Current hypertension urgency or emergency (SBP > 180mmHg or DBP > 120mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertension Canada Professional Certification Program: HC-PCPThe 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. | Behavioural | Intervention pharmacists |
Primary outcome
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.
1 secondary outcome
Consultant Satisfaction Questionnaire
Time frame: 6 months following follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Tsuyuki, PharmD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertension Canada Professional Certification Program: HC-PCP in people with Hypertension, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.