Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001022459
Ethics application status
Approved
Date submitted
7/07/2025
Date registered
16/09/2025
Date last updated
16/09/2025
Date data sharing statement initially provided
16/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacist Role In the Management and Education of hypertension to manage blood pressure
Scientific title
Pharmacist Role In the Management and Education to manage blood pressure in adults with uncontrolled hypertension
Secondary ID [1] 314835 0
DG23/7050
Universal Trial Number (UTN)
Trial acronym
PRIME-BP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 338102 0
Condition category
Condition code
Cardiovascular 334401 334401 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The multi-modal intervention will be delivered once only- at the time the participant is screened, consented, and randomised in the pharmacy.

The intervention involves
1) delivery of a structured education session ('Hypertension MedsCheck') by pharmacists when the patient presents for anti-hypertensive medication with uncontrolled BP (greater than or equal to140/90 mmHg) measured at pharmacy and
2) independent use of a standardised co-designed education package to support self-management of blood pressure, called the ’BP Toolkit’.

Intervention participants will receive a brief medication review modelled off the MedsCheck program, a structured clinical pharmacy service funded by the Australian Government through the Pharmacy Programs Administrator, This session will involve a 20-minute face-to-face consultation where a registered pharmacist will review a participant’s blood pressure and cardiovascular medication regimen and develop a medication profile and action plan. The focus is on education and self-management, identifying medication-related problems, improving medication use, and providing education on best practices.

The education session delivered by pharmacists will include:
1) Brief medication review: review of the participants cardiovascular medications.

2) Action-planning: The pharmacist will work with the participant to develop a personalised plan and set realistic 6-month goals. This session will include identifying and setting goals in relation to one or more of the following management practices: medication adherence, lifestyle (e.g., diet and exercise), exploration of additional heart disease risk factors, or scheduling regular blood pressure checks and/or home blood pressure measurement. Pharmacists and participants will be encouraged to set 3-5 goals in the SMART format, as is recommended during a standard MedsCheck (Specific, Measurable, Achievable, Relevant, Time-bound). Based on the medication review, action-planning session and the participant’s blood pressure readings; the pharmacist will also provide recommendations for when the participant should be reviewed by their general practitioner. Participants will be provided with a copy of the action-plan and will be encouraged to take it with them to see their general practitioner.

3) Introduction and brief demonstration of the BP Toolkit to support ongoing engagement for blood pressure management and to ensure participants are comfortable navigating and utilising the website. The BP Toolkit is a standardised co-designed educational package of evidence-based recommendations for patients to self-monitor blood pressure and navigate blood pressure management activities, including guidance to obtain an accurate blood pressure device; instructions to measure blood pressure at home; resources to record and report blood pressure to healthcare providers, including prompts to visit a general practitioner, and lifestyle and medication advice.

The pharmacist will demonstrate and guide participants through the BP Toolkit website, providing a comprehensive overview that includes an introduction to the site, instructions on navigation, and a demonstration of its key features and functionalities. Personalised guidance will be offered based on each participant’s identified issues as outlined in their individual action plans. Participants will also be shown how to access and use the website independently and will be encouraged to explore and utilise the BP Toolkit at their own discretion following the session. After the face-to-face intervention, each participant will be emailed a copy of their personalised action plan and signed consent form, a link to the BP Toolkit website, and information on how to contact the research team.
Usability data will be collected from the BP Toolkit website, including the number of logins, time spent on the website and within each topic, and the use of interactive features such as storing blood pressure readings and downloading website resources.

4) Follow-up: As is recommended for a standard MedsCheck, pharmacists will be recommended to communicate the patient’s action-plan with the prescribing general practitioner and informing them about the trial. It is recommended that this communication provide a summary of the study, including tailored recommendations and goals established during the structured education session, as well as any necessary follow-up actions, reinforcing the key points covered during the session. Pharmacists may choose how they wish to communicate with general practitioners (such as via phone, email or fax).

Six months following randomisation and intervention delivery, participants will return to the pharmacy for a follow-up visit. During this visit, their blood pressure will be measured, and they will complete an online questionnaire to assess whether they have achieved the goals outlined in their personalised action plan.
Intervention code [1] 331438 0
Behaviour
Comparator / control treatment
Participants in the control arm will receive usual care. This will involve the pharmacist informing them that their average blood pressure reading is equal to or greater than140/90mmHg and advising them to visit their general practitioner. Control participants will return to the pharmacy at 6-months for follow-up assessment and then be given access to the BP Toolkit website.
Control group
Active

Outcomes
Primary outcome [1] 342084 0
Difference between groups in change in systolic blood pressure
Timepoint [1] 342084 0
Baseline and 6 months post randomisation
Secondary outcome [1] 449514 0
Change in diastolic blood pressure
Timepoint [1] 449514 0
Baseline and 6 months post randomisation
Secondary outcome [2] 449515 0
Proportion (%) of participants with blood pressure controlled (<140/90 mmHg)
Timepoint [2] 449515 0
Baseline and 6 months post randomisation
Secondary outcome [3] 449516 0
Change in medication regimen
Timepoint [3] 449516 0
Baseline and 6 months post randomisation
Secondary outcome [4] 449517 0
Use of healthcare services and healthcare visits. This will be assessed together as a composite secondary outcome
Timepoint [4] 449517 0
Baseline and 6 months post randomisation
Secondary outcome [5] 449518 0
Change in medication adherence score
Timepoint [5] 449518 0
Baseline and 6 months post randomisation
Secondary outcome [6] 449519 0
Change in patient activation score
Timepoint [6] 449519 0
Baseline and 6 months post randomisation
Secondary outcome [7] 449520 0
Change in lifestyle cardiovascular risk factors
Timepoint [7] 449520 0
Baseline and 6 months post randomisation
Secondary outcome [8] 449521 0
Change in blood pressure self-monitoring factors (e.g., frequency)
Timepoint [8] 449521 0
Baseline and 6 months post randomisation
Secondary outcome [9] 449522 0
Reach of intervention- Number and characteristics of individuals who participate in the study. A process evaluation will be conducted to determine the feasibility, acceptability, and effectiveness of the intervention using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Planning and Evaluation framework. Each component of the RE-AIM framework will be listed as a separate secondary outcome.
Timepoint [9] 449522 0
For semi structured interviews: 1. People participating in the Randomised Controlled Trial: One month and 6 months post randomisation 2. Pharmacists: One month and 6 months post randomisation 3. General Practitioners: 3 months and 6 months post randomisation Other methods- Baseline and 6 months post randomisation
Secondary outcome [10] 450950 0
Effectiveness of intervention - Effectiveness of intervention in Blood pressure management including self-management A process evaluation will be conducted to determine the feasibility, acceptability, and effectiveness of the intervention using the RE-AIM planning and evaluation framework. Each component of the RE-AIM framework will be listed as a separate secondary outcome.
Timepoint [10] 450950 0
Baseline and 6 months post randomisation
Secondary outcome [11] 450951 0
Adoption of the intervention - The proportion and representativeness of pharmacy sites that implement the intervention. A process evaluation will be conducted to determine the feasibility, acceptability, and effectiveness of the intervention using the RE-AIM planning and evaluation framework. Each component of the RE-AIM framework will be listed as a separate secondary outcome.
Timepoint [11] 450951 0
For semi structured interviews: 1. People participating in the Randomised Controlled Trial: One month and 6 months post randomisation 2. Pharmacists: One month and 6 months post randomisation 3. General Practitioners: 3 months and 6 months post randomisation Other methods - Baseline and 6 months post randomisation
Secondary outcome [12] 450952 0
Implementation of the intervention - degree to which the intervention is delivered as intended. Data will be collected among trial participants, pharmacists and GPs A process evaluation will be conducted to determine the feasibility, acceptability, and effectiveness of the intervention using the RE-AIM planning and evaluation framework. Each component of the RE-AIM framework will be listed as a separate secondary outcome.
Timepoint [12] 450952 0
For semi structured interviews: 1. People participating in the Randomised Controlled Trial: One month and 6 months post randomisation 2. Pharmacists: One month and 6 months post randomisation 3. General Practitioners: 3 months and 6 months post randomisation Other methods- 6 months post randomisation
Secondary outcome [13] 450953 0
Maintenance of the intervention - Sustained use of the BP Toolkit after follow-up period A process evaluation will be conducted to determine the feasibility, acceptability, and effectiveness of the intervention using the RE-AIM planning and evaluation framework. Each component of the RE-AIM framework will be listed as a separate secondary outcome.
Timepoint [13] 450953 0
Interview for people participating in the Randomised Controlled Trial: One month and 6 months post randomisation. BP Toolkit user-data: After 6 months post randomisation
Secondary outcome [14] 450954 0
Capability - Capability to change will be assessed using the Capability, Opportunity, Motivation – Behaviour (COM-B) framework of behaviour change. Each component of the COM-B will be listed as a separate secondary outcome.
Timepoint [14] 450954 0
6 months post randomisation
Secondary outcome [15] 450957 0
Opportunity - Opportunity to change will be assessed using the Capability, Opportunity, Motivation – Behaviour (COM-B) framework of behaviour change. Each component of the COM-B will be listed as a separate secondary outcome.
Timepoint [15] 450957 0
6 months post randomisation
Secondary outcome [16] 452005 0
Motivation - Opportunity to change will be assessed using the Capability, Opportunity, Motivation – Behaviour (COM-B) framework of behaviour change. Each component of the COM-B will be listed as a separate secondary outcome.
Timepoint [16] 452005 0
6 months post randomisation

Eligibility
Key inclusion criteria
Adult participants (aged 18-70 years) who visit the pharmacy for dispensing of their anti-hypertensive medication for the purpose of BP management and uncontrolled BP, defined as unobserved pharmacy-measured BP of equal to or greater than 140/90 mmHg. Eligible participants must have been on BP medication for at least three months and be taking no more than three different classes of BP medications, including single-pill combinations.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who have had a change in antihypertensive medications within the past 6 months. People who are currently pregnant, planning a pregnancy and/or breastfeeding will be excluded from the study due to the distinct nature of BP management during pregnancy and the postpartum period. BP regulation in pregnant individuals requires specialised care and protocols that differ from the general population. People who live with someone who is already enrolled in the study. People who have a severe co-existing medical condition and/or a planned major cardiovascular procedure in the next 6-months that would impede or prevent engagement in the intervention e.g., dementia, terminal illness or Transcatheter Aortic Valve Implantation, or who are already participating in another health and/or medicine related clinical trial or who are unable to give consent will also be excluded.

For safety reasons, people will also be excluded if they are found at the time of assessment in pharmacy to have an average systolic BP equal to or greater than180 mmHg and/or diastolic BP equal to or greater than 110 mmHg.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment at the pharmacy will be maintained by using a computer-generated randomisation process on REDCap software and will not be revealed until after baseline data collection. All procedures undertaken by pharmacy staff interacting with participants before allocation will be identical. At the participant level, all participants will receive the same information and undergo the same initial protocol prior to allocation. This approach prevents selection bias and ensures that the allocation sequence is not known prior to the participant’s enrolment in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After providing consent pharmacy personnel will submit the REDCap form and participants will be randomly allocated (1:1) using computer generated randomisation to either the intervention group or the control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome, a total sample size of 360 participants (n=130/group) will provide 80% power at the 5% significance level, with a standard deviation of 14.3 to detect a clinically significant difference of 5 mmHg between the intervention and usual-care groups based on a two-sample, two-sided t-test. Assuming a drop-out or loss to follow-up rate of 20%, the sample size has been increased to 430 in total, with 215 participants in each group.

Quantitative analysis. All analyses will follow the intention-to-treat principle and be conducted by a study member blinded to allocation. A comparison of baseline characteristics will be conducted by t-test for continuous data and a chi-squared test for categorical data. If there are any differences in these starting characteristics, we will adjust for them using analysis of covariance (ANCOVA) when looking at changes in systolic blood pressure between the intervention and usual-care groups. Otherwise, the analysis will adjust for the baseline systolic blood pressure level only. Subgroup analyses will be undertaken for cultural and linqustic diversity, sex/gender, age, and sociodemographic characteristics. We will check for any patterns in missing data and use multiple imputation, if needed.
For a concurrent process evaluation and to achieve the secondary outcomes, participants will be purposively sampled using an information power approach for recruitment and data saturation. Participants will be selected based on demographic characteristics to achieve a diverse and representable sample from each participating site and location and will include a sufficient sample size based on the richness of the data collected.

Process evaluation. Quantitative data will be analysed by descriptive statistics. Qualitative data will be interpreted using inductive-deductive thematic and content analysis with two researchers independently identifying a preliminary list of themes. NVivo will be used to code and map data in preparation for analysis. Additionally, data triangulation will be undertaken using the Bazely’s framework of ‘describe-compare-relate’ to compare themes between patients and practitioners according to RE-AIM outcomes (Reach, Effectiveness, Adoption, Implementation, and Maintenance) for service implementation evaluation and COM-B outcomes (capability, opportunity and motivation – behaviour) for individual behaviour change. All analysis will be undertaken by two or more independent researchers.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/10/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2027
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
430
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319394 0
Government body
Name [1] 319394 0
New South Wales Health, Office of Health and Medical Research
Country [1] 319394 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321880 0
None
Name [1] 321880 0
Address [1] 321880 0
Country [1] 321880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317968 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317968 0
Ethics committee country [1] 317968 0
Australia
Date submitted for ethics approval [1] 317968 0
06/03/2025
Approval date [1] 317968 0
18/06/2025
Ethics approval number [1] 317968 0
2025/HE000207

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142722 0
Dr Niamh Chapman
Address 142722 0
University of Sydney. Camperdown, 2006 NSW
Country 142722 0
Australia
Phone 142722 0
+61 2 93519073
Fax 142722 0
Email 142722 0
[email protected]
Contact person for public queries
Name 142723 0
Niamh Chapman
Address 142723 0
University of Sydney. Camperdown, 2006 NSW
Country 142723 0
Australia
Phone 142723 0
+61 2 93519073
Fax 142723 0
Email 142723 0
[email protected]
Contact person for scientific queries
Name 142724 0
Niamh Chapman
Address 142724 0
University of Sydney. Camperdown, 2006 NSW
Country 142724 0
Australia
Phone 142724 0
+61 2 93519073
Fax 142724 0
Email 142724 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.