HypertensionNCT07822022
Implementing Improved Blood Pressure Measurement in General Practice: A Multisite Implementation Trial Using Automated Office Blood Pressure (AOBP)
A study testing Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol in people with Hypertension and Cardiovascular Diseases (CVD), run by Menzies Institute for Medical Research at 1 site in Australia.
Trial summary
The goal of this clinical trial is to evaluate whether implementation of guideline-recommended Automated Office Blood Pressure (AOBP) measurement in Australian general practice clinics improves hypertension control among adults aged 18 years and older who are eligible for blood pressure assessment as part of routine… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cardiovascular Diseases (CVD), Vascular Diseases
- What is being tested?
- Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2026to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 will be eligible to participate if they meet Australian guideline-recommended criteria for BP measurement, either for absolute CVD risk assessment or for BP assessment as an individual risk factor, and are attending a participating general practice clinic during the study period.
- Eligible participants include:
- Adults attending participating general practice clinics who are eligible for BP measurement for absolute CVD risk assessment, including:
- Adults aged 45 to 79 years without known CVD
- Adults aged 35 to 79 years with diabetes and without known CVD
- First Nations peoples aged 30 to 79 years without known CVD
Show all 9Show fewer
- Adults eligible for BP assessment as an individual risk factor, including:
- First Nations peoples aged 18 to 29 years
- Adults aged 18 years and over where BP measurement is clinically indicated based on individual risk factors or clinical judgement (e.g. suspected hypertension from BP measurements outside the clinic, obesity, abnormal cholesterol levels, secondary causes of hypertension, or time elapsed since last BP measurement)
Who cannot join
- Patients who are unable to provide informed consent.
- Patients whose participation is deemed clinically inappropriate by the treating general practitioner.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Menzies Institute for Medical Research, University of Tasmania
Hobart, Tasmania, 7000
James E Sharman, PhD, +61 3 6226 4709, james.sharman@utas.edu.au
James E Sharman, PhD
About this study
The goal of this clinical trial is to evaluate whether implementation of guideline-recommended Automated Office Blood Pressure (AOBP) measurement in Australian general practice clinics improves hypertension control among adults aged 18 years and older who are eligible for blood pressure assessment as part of routine clinical care. The study will also evaluate the implementation, sustainability, and health economic impact of AOBP in real-world primary care settings.
The main questions it aims to answer are:
Read more
- Does implementation of AOBP increase the proportion of patients with treated and controlled hypertension compared with the pre-implementation period?
- Can AOBP be successfully adopted, implemented, integrated into routine general practice workflows, and maintained over time?
Researchers will compare outcomes following implementation of AOBP with routinely collected clinical data from the period before implementation.
Participants will:
- Provide informed consent and have their AOBP measurements performed during routine general practice visits.
- Consent to the collection of AOBP measurement and relevant clinical information from their medical records for study evaluation.
- Continue to receive usual clinical care from their general practitioner.
General practice staff will receive AOBP training, perform AOBP measurements, and participate in implementation evaluation activities.
Read the detailed description
Hypertension is the most common condition managed in general practice and remains one of the leading modifiable risk factors for cardiovascular disease (CVD). Accurate blood pressure (BP) measurement is fundamental to hypertension diagnosis and management; however, guideline-recommended clinic BP measurement procedures are often difficult to implement in routine practice because of time, staffing, and workflow constraints. General practitioners have reported that guideline-recommended BP measurement approaches are frequently impractical in routine clinical care, which may contribute to reduced confidence in clinic BP readings and therapeutic inertia.
Automated Office Blood Pressure (AOBP) measurement is a standardized approach to clinic BP assessment designed to reduce observer and procedural bias. The method incorporates an automated rest period followed by repeated automated measurements obtained while the patient remains seated, quiet, and undisturbed. AOBP values correlate closely with out-of-office BP measurement methods and, in 2025, AOBP was endorsed by Hypertension Australia and the National Hypertension Taskforce as the recommended standard for clinic BP measurement in Australia.
AOBP is typically performed by a trained staff member before the patient sees the general practitioner, in a quiet area outside the consultation room. This approach is intended to provide a more standardized BP assessment, reduce demands on consultation time, and support clinical decision-making through more reliable BP information while maintaining existing clinical care pathways and clinician responsibility for diagnosis, treatment, follow-up, and referral decisions.
Despite guideline endorsement and supporting evidence, AOBP has not been routinely implemented in Australian general practice. Barriers to implementation are predominantly structural rather than clinical and include limited access to validated equipment, staff training requirements, workflow integration challenges, and the absence of coordinated implementation support.
The study was informed by extensive co-design work involving general practitioners, practice staff, partner organisations, and community members. Previous pilot implementation work demonstrated that AOBP could be integrated into general practice workflows and was considered feasible, acceptable, and adaptable across diverse practice settings when supported by appropriate training, workflow integration, and governance arrangements. GPs participating in pilot implementation work reported increased trust in BP readings and greater confidence in hypertension management.
This study is a pragmatic, multisite, hybrid type 2 implementation-effectiveness trial using a non-randomised pre-post design. Approximately 40 Australian general practice clinics will participate in the study, with implementation occurring within each clinic over a 12-month period followed by a 6-month maintenance phase. The study has been designed to evaluate implementation of Automated Office Blood Pressure (AOBP) measurement within routine primary care settings and examine factors influencing implementation and sustainability in general practice.
The hybrid type 2 implementation-effectiveness design was selected to enable simultaneous evaluation of implementation and effectiveness under real-world conditions. Evaluation is guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and the Practical, Robust Implementation and Sustainability Model (PRISM). RE-AIM provides the overarching framework for evaluation of effectiveness and implementation outcomes, while PRISM is used to identify barriers, enablers, contextual factors, adaptations, and determinants of implementation and sustainability.
In addition to implementation and effectiveness evaluations, the study will examine health economic considerations associated with implementation of AOBP in general practice and will explore longer-term health outcomes through approved linkage to routinely collected administrative and health datasets where available. These evaluations are intended to complement trial findings and inform future implementation, scale-up, and sustainability of AOBP in Australian primary care settings.
- Being tested
- Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol
- Keywords
- Hypertension, Automated Office Blood Pressure, AOBP, General Practice, Implementation Science, Evaluation Research, Blood Pressure Monitoring
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Office Blood Pressure (AOBP) Standardized Measurement ProtocolDevice
Implementation of a standardized AOBP measurement protocol using a validated automated sphygmomanometer. AOBP measurements will be conducted by trained general practice staff. Patients will be seated in a quiet area with back supported, feet flat on the floor, arm supported at heart level, and an appropriately sized cuff applied. Following a 5-minute automated rest period, the device automatically records three seated blood pressure measurements at 30-second intervals and a fourth brief measurement to detect arrhythmia/atrial fibrillation. The device automatically calculates and records the average of the three seated measurements, heart rate, and arrhythmia status. Where clinically indicated, a standing protocol will be performed following the seated protocol and consists of two standing blood pressure measurements recorded at 30-second intervals after 1 minute of standing, followed by an arrhythmia assessment. Results are provided to the treating general practitioner.
| Study group | Role | What they receive |
|---|---|---|
| AOBP Implementation Intervention | Other | Not described Receives: Device: Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with treated and controlled hypertension, with the primary estimand being the absolute difference in this proportion between the pre-implementation period and 12-month AOBP implementation period.
Hypertension control will be defined according to Australian guideline recommendations using AOBP thresholds (average systolic BP <135 mmHg and diastolic BP <85 mmHg).
"Treated" refers to patients receiving antihypertensive therapy.
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Secondary outcomes (24)
Average systolic and diastolic BP measured using AOBP
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Heart rate recording during AOBP measurement
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Frequency of repeat AOBP measures during the study period
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in systolic and diastolic blood pressure values over time, measured using AOBP
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Clinician-measured BP values recorded in the electronic medical record, where available
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Initiation of antihypertensive therapy
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Intensification of antihypertensive therapy
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in antihypertensive medication prescribing patterns
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in cardiovascular medication prescribing patterns
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Proportion of participants receiving treatment for hypertension
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented referral for further assessment related to elevated BP (detected by AOBP device)
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented follow-up investigations related to elevated BP (detected by AOBP device [e.g. electrocardiogram monitoring, standard clinic blood pressure measurement, home BP monitoring, 24-hour ambulatory BP monitoring])
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Dates of clinic visits related to elevated BP (detected by AOBP device), where available
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Proportion of participants with possible arrhythmia (including AF) indicated by the AOBP device
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented referral for further assessment of possible arrhythmia (including AF) indicated by the AOBP device
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Dates of clinic visits related to possible arrhythmia (including AF) indicated by AOBP device, where available
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Completion of an absolute CVD risk calculation
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documentation of patient characteristics relevant to cardiovascular risk (e.g. age, sex, smoking status, relevant CVD risk factors and pathology [i.e. cholesterol, glucose] and clinical conditions such as diabetes)
Measured: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Implementation outcomes will be evaluated within the overarching RE-AIM framework and will include measures of Reach, Adoption, Implementation and Maintenance.
These will examine participation and uptake of AOBP, fidelity, feasibility, acceptability, integration into routine practice, and sustained use during the maintenance period.
Measured: Assessed throughout the 12-month AOBP implementation period, with Maintenance assessed at 18 months following the 6-month maintenance phase.
PRISM (Practical, Robust Implementation and Sustainability Model) will guide the implementation component by identifying anticipated and experienced barriers and enablers, and contextual factors influencing implementation and sustainability.
Measured: Assessed throughout the 12-month AOBP implementation period, with Maintenance assessed at 18 months following the 6-month maintenance phase.
Costs associated with implementation of AOBP at the practice level, including equipment, staff training, workflow integration, and ongoing quality assurance
Measured: Outcome assessed 12-months following AOBP implementation period.
Costs per patient correctly diagnosed and managed for hypertension using AOBP compared with usual care BP measurement
Measured: Outcome assessed 12-months following AOBP implementation period.
Practice level and system level costs related to changes in clinical management, including antihypertensive prescribing and follow up
Measured: Outcome assessed 12-months following AOBP implementation period.
Downstream health service utilisation and cost implications associated with CVD events, hospitalisations, and mortality (where data permit)
Measured: Outcome assessed 12-months following AOBP implementation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
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.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participating general practice clinics will implement a standardized Automated Office Blood Pressure (AOBP) measurement protocol with patients as part of routine clinical practice following site onboarding and staff training. All consented patients will receive the intervention. This study is a pragmatic, multisite, hybrid type 2 implementation-effectiveness trial using a non-randomised pre-post design with participating practices serving as their own controls. Outcomes following implementation of AOBP will be compared with routinely collected baseline clinical data collected prior to implementation.
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Hypertension Australia, Australian Cardiovascular Alliance, Pharmaceutical Society of Australia, Ochre Health, Uscom Limited, JA Davey, A&D Australasia, Servier Laboratories (Australia) Pty Ltd, National Heart Foundation, Australia
- Responsible party
- Principal investigator, James E Sharman, Menzies Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822022
- Sponsor's protocol ID
- H40663
- Other IDs
- Grant ID 2053493
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Improved Blood Pressure Measurement in General Practice: A Multisite Implementation Trial Using Automated Office Blood Pressure (AOBP)
- ClinicalTrials.gov ID
- NCT07822022
- Acronym / sponsor ID
- H40663
- Keywords
- Hypertension, Automated Office Blood Pressure, AOBP, General Practice, Implementation Science, Evaluation Research, Blood Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Menzies Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Hypertension Australia, Australian Cardiovascular Alliance, Pharmaceutical Society of Australia, Ochre Health, Uscom Limited, JA Davey, A&D Australasia, Servier Laboratories (Australia) Pty Ltd, National Heart Foundation, Australia
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 16 Sep 2026 (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.
The goal of this clinical trial is to evaluate whether implementation of guideline-recommended Automated Office Blood Pressure (AOBP) measurement in Australian general practice clinics improves hypertension control among adults aged 18 years and older who are eligible for blood pressure assessment as part of routine clinical care. The study will also evaluate the implementation, sustainability, and health economic impact of AOBP in real-world primary care settings.
The main questions it aims to answer are:
- Does implementation of AOBP increase the proportion of patients with treated and controlled hypertension compared with the pre-implementation period?
- Can AOBP be successfully adopted, implemented, integrated into routine general practice workflows, and maintained over time?
Researchers will compare outcomes following implementation of AOBP with routinely collected clinical data from the period before implementation.
Participants will:
- Provide informed consent and have their AOBP measurements performed during routine general practice visits.
- Consent to the collection of AOBP measurement and relevant clinical information from their medical records for study evaluation.
- Continue to receive usual clinical care from their general practitioner.
General practice staff will receive AOBP training, perform AOBP measurements, and participate in implementation evaluation activities.
Detailed description
Hypertension is the most common condition managed in general practice and remains one of the leading modifiable risk factors for cardiovascular disease (CVD). Accurate blood pressure (BP) measurement is fundamental to hypertension diagnosis and management; however, guideline-recommended clinic BP measurement procedures are often difficult to implement in routine practice because of time, staffing, and workflow constraints. General practitioners have reported that guideline-recommended BP measurement approaches are frequently impractical in routine clinical care, which may contribute to reduced confidence in clinic BP readings and therapeutic inertia.
Automated Office Blood Pressure (AOBP) measurement is a standardized approach to clinic BP assessment designed to reduce observer and procedural bias. The method incorporates an automated rest period followed by repeated automated measurements obtained while the patient remains seated, quiet, and undisturbed. AOBP values correlate closely with out-of-office BP measurement methods and, in 2025, AOBP was endorsed by Hypertension Australia and the National Hypertension Taskforce as the recommended standard for clinic BP measurement in Australia.
AOBP is typically performed by a trained staff member before the patient sees the general practitioner, in a quiet area outside the consultation room. This approach is intended to provide a more standardized BP assessment, reduce demands on consultation time, and support clinical decision-making through more reliable BP information while maintaining existing clinical care pathways and clinician responsibility for diagnosis, treatment, follow-up, and referral decisions.
Despite guideline endorsement and supporting evidence, AOBP has not been routinely implemented in Australian general practice. Barriers to implementation are predominantly structural rather than clinical and include limited access to validated equipment, staff training requirements, workflow integration challenges, and the absence of coordinated implementation support.
The study was informed by extensive co-design work involving general practitioners, practice staff, partner organisations, and community members. Previous pilot implementation work demonstrated that AOBP could be integrated into general practice workflows and was considered feasible, acceptable, and adaptable across diverse practice settings when supported by appropriate training, workflow integration, and governance arrangements. GPs participating in pilot implementation work reported increased trust in BP readings and greater confidence in hypertension management.
This study is a pragmatic, multisite, hybrid type 2 implementation-effectiveness trial using a non-randomised pre-post design. Approximately 40 Australian general practice clinics will participate in the study, with implementation occurring within each clinic over a 12-month period followed by a 6-month maintenance phase. The study has been designed to evaluate implementation of Automated Office Blood Pressure (AOBP) measurement within routine primary care settings and examine factors influencing implementation and sustainability in general practice.
The hybrid type 2 implementation-effectiveness design was selected to enable simultaneous evaluation of implementation and effectiveness under real-world conditions. Evaluation is guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and the Practical, Robust Implementation and Sustainability Model (PRISM). RE-AIM provides the overarching framework for evaluation of effectiveness and implementation outcomes, while PRISM is used to identify barriers, enablers, contextual factors, adaptations, and determinants of implementation and sustainability.
In addition to implementation and effectiveness evaluations, the study will examine health economic considerations associated with implementation of AOBP in general practice and will explore longer-term health outcomes through approved linkage to routinely collected administrative and health datasets where available. These evaluations are intended to complement trial findings and inform future implementation, scale-up, and sustainability of AOBP in Australian primary care settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participating general practice clinics will implement a standardized Automated Office Blood Pressure (AOBP) measurement protocol with patients as part of routine clinical practice following site onboarding and staff training. All consented patients will receive the intervention. This study is a pragmatic, multisite, hybrid type 2 implementation-effectiveness trial using a non-randomised pre-post design with participating practices serving as their own controls. Outcomes following implementation of AOBP will be compared with routinely collected baseline clinical data collected prior to implementation.
| Arm | Type | Receives |
|---|---|---|
| AOBP Implementation Intervention | Other | Device: Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients will be eligible to participate if they meet Australian guideline-recommended criteria for BP measurement, either for absolute CVD risk assessment or for BP assessment as an individual risk factor, and are attending a participating general practice clinic during the study period.
- Adults attending participating general practice clinics who are eligible for BP measurement for absolute CVD risk assessment, including:
- Adults aged 45 to 79 years without known CVD
- Adults aged 35 to 79 years with diabetes and without known CVD
- First Nations peoples aged 30 to 79 years without known CVD
Key exclusion criteria (2 listed)
- Patients who are unable to provide informed consent.
- Patients whose participation is deemed clinically inappropriate by the treating general practitioner.
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 |
|---|---|---|
| Automated Office Blood Pressure (AOBP) Standardized Measurement ProtocolImplementation of a standardized AOBP measurement protocol using a validated automated sphygmomanometer. AOBP measurements will be conducted by trained general practice staff. Patients will be seated in a quiet area with back supported, feet flat on the floor, arm supported at heart level, and an appropriately sized cuff applied. Following a 5-minute automated rest period, the device automatically records three seated blood pressure measurements at 30-second intervals and a fourth brief measurement to detect arrhythmia/atrial fibrillation. The device automatically calculates and records the average of the three seated measurements, heart rate, and arrhythmia status. Where clinically indicated, a standing protocol will be performed following the seated protocol and consists of two standing blood pressure measurements recorded at 30-second intervals after 1 minute of standing, followed by an arrhythmia assessment. Results are provided to the treating general practitioner. | Device | AOBP Implementation Intervention |
Primary outcome
The proportion of patients with treated and controlled hypertension, with the primary estimand being the absolute difference in this proportion between the pre-implementation period and 12-month AOBP implementation period.
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Hypertension control will be defined according to Australian guideline recommendations using AOBP thresholds (average systolic BP <135 mmHg and diastolic BP <85 mmHg). "Treated" refers to patients receiving antihypertensive therapy.
24 secondary outcomes
Average systolic and diastolic BP measured using AOBP
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Heart rate recording during AOBP measurement
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Frequency of repeat AOBP measures during the study period
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in systolic and diastolic blood pressure values over time, measured using AOBP
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Clinician-measured BP values recorded in the electronic medical record, where available
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Initiation of antihypertensive therapy
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Intensification of antihypertensive therapy
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in antihypertensive medication prescribing patterns
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in cardiovascular medication prescribing patterns
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Proportion of participants receiving treatment for hypertension
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented referral for further assessment related to elevated BP (detected by AOBP device)
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented follow-up investigations related to elevated BP (detected by AOBP device [e.g. electrocardiogram monitoring, standard clinic blood pressure measurement, home BP monitoring, 24-hour ambulatory BP monitoring])
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Dates of clinic visits related to elevated BP (detected by AOBP device), where available
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Proportion of participants with possible arrhythmia (including AF) indicated by the AOBP device
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented referral for further assessment of possible arrhythmia (including AF) indicated by the AOBP device
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Dates of clinic visits related to possible arrhythmia (including AF) indicated by AOBP device, where available
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Completion of an absolute CVD risk calculation
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documentation of patient characteristics relevant to cardiovascular risk (e.g. age, sex, smoking status, relevant CVD risk factors and pathology [i.e. cholesterol, glucose] and clinical conditions such as diabetes)
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Implementation outcomes will be evaluated within the overarching RE-AIM framework and will include measures of Reach, Adoption, Implementation and Maintenance.
Time frame: Assessed throughout the 12-month AOBP implementation period, with Maintenance assessed at 18 months following the 6-month maintenance phase.
PRISM (Practical, Robust Implementation and Sustainability Model) will guide the implementation component by identifying anticipated and experienced barriers and enablers, and contextual factors influencing implementation and sustainability.
Time frame: Assessed throughout the 12-month AOBP implementation period, with Maintenance assessed at 18 months following the 6-month maintenance phase.
Costs associated with implementation of AOBP at the practice level, including equipment, staff training, workflow integration, and ongoing quality assurance
Time frame: Outcome assessed 12-months following AOBP implementation period.
Costs per patient correctly diagnosed and managed for hypertension using AOBP compared with usual care BP measurement
Time frame: Outcome assessed 12-months following AOBP implementation period.
Practice level and system level costs related to changes in clinical management, including antihypertensive prescribing and follow up
Time frame: Outcome assessed 12-months following AOBP implementation period.
Downstream health service utilisation and cost implications associated with CVD events, hospitalisations, and mortality (where data permit)
Time frame: Outcome assessed 12-months following AOBP implementation period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol in people with Hypertension and Cardiovascular Diseases (CVD), run by Menzies Institute for Medical Research at 1 site in Australia.
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 9 inclusion and 2 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: opening soon, as of the sponsor's last update on 16 Sep 2026. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James E Sharman, PhD (+61 3 6226 4709, james.sharman@utas.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with treated and controlled hypertension, with the primary estimand being the absolute difference in this proportion between the pre-implementation period and 12-month AOBP implementation period. (time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.). 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 16 Sep 2026.