HypertensionNCT00202137
Home Blood Pressure Monitoring and Blood Pressure Control
A study testing Home blood pressure monitoring and Physician monitoring of blood pressure in people with Hypertension, run by Queen's University at 1 site in Canada.
Trial summary
Hypertension is a common problem in Canada with a prevalence of about 15%. The goal of hypertension therapy should be to maximize blood pressure control. Home blood pressure monitoring (HBPM) devices are available and many patients are using them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Home blood pressure monitoring and Physician monitoring of blood pressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2002to Jun 2007
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults age 18 years and older with essential hypertension.
- who are treated with medication to lower their blood pressure.
- whose mean daytime blood pressure at enrolment is 135/85 mm Hg or greater.
- and who are not currently using HBPM.
Who cannot join
- a diagnosis of secondary hypertension.
- pregnancy.
- hypertension management primarily by a consultant.
- a disability that precludes use of a home blood pressure monitor.
- enrolled in another hypertension trial
- white coat hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of the Effects of Home Blood Pressure Monitoring on Blood Pressure Control
Hypertension is a common problem in Canada with a prevalence of about 15%. The goal of hypertension therapy should be to maximize blood pressure control. Home blood pressure monitoring (HBPM) devices are available and many patients are using them. The role that self-monitoring of blood pressure can play in optimizing blood pressure control is unclear. We hope to clarify the role of home blood pressure monitoring in the treatment of hypertension and explore how it may affect patient and physician behaviours related to blood pressure management. This study will compare a group of hypertensive patients who use HBPM with those who do not use these devices. The intervention (HBPM) group will measure their blood pressure at home a minimum of once weekly and will report these measurements to their family doctor at each visit. The control group will receive usual care as delivered by their family doctor. Outcomes of blood pressure control will be measured over a 12 month period. Outcomes will be determined primarily by 24 hour ambulatory blood pressure monitoring and by reviewing data in patient's charts located in family physicians office. Fifty family physicians from the Kingston area have agreed to participate.
Read the detailed description
The objective of this study is to measure the effect of home (self) blood pressure monitoring on control of hypertension in a primary care setting.
This research is important for several reasons:
- Lack of control of hypertension is common and is associated with morbidity and mortality. ii) The costs of managing hypertensions are high, not only because of the prevalence of hypertension, but also because maintenance of control must exist over many years for most patients. iii) Home blood pressure monitoring is increasingly being used by patients. iv) Guidelines for home blood pressure monitoring are already being developed and distributed.
- While it would seem helpful to increase self-care by patients, there is currently conflicting or inadequate evidence that home monitoring is useful.
The main hypothesis of the study is that, compared to patients who receive usual care, patients who use home monitoring will have lower blood pressure levels.
Our secondary hypothesis is that HBPM changes physician and patient behaviours in ways that would result in better control of hypertension.
The methodology uses cluster randomization. Physicians will be randomly allocated to either have their patients use the intervention or to continue with usual care. The intervention for the experimental group is the provision of a home blood pressure monitor to patients with a request that they record weekly blood pressure measurements and report them to their family physician at their regular hypertension follow-up visits. The physicians will be informed of current guidelines for target levels for home monitored blood pressure. The control group will receive usual care.
The main outcome measures will be blood pressure level (by 24 hour ambulatory monitoring) at baseline, 6 months and 12 months.
The secondary objective of this study is to measure the effect of home monitoring on physicians' and patients' behaviours related to hypertension control. Behaviours that will be measured include the intensity and type of pharmacological treatment, compliance with antihypertensive medication and changes in patient's lifestyle.
- Conditions
- Hypertension
- Being tested
- Home blood pressure monitoring, Physician monitoring of blood pressure
- Keywords
- Home Blood Pressure, Hypertension, Blood Pressure Control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home blood pressure monitoringBehavioural
Monitor blood pressure using home blood pressure monitor
Physician monitoring of blood pressureBehavioural
Blood pressure measured as standard care from physician (no home monitor given for blood pressure monitoring)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | home blood pressure monitoring with automatic blood pressure device Receives: Behavioral: Home blood pressure monitoring |
| 2 | Active comparator | physician monitoring of blood pressure by 3 monthly office visits Receives: Behavioral: Physician monitoring of blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean nighttime blood pressures on ABPM.
Measured: 6mth and 1yr
Achieving BP target at end of study
Measured: 6mt and 1yr
Secondary outcomes (7)
patient lifestyle changes.
Measured: 6mth and 1yr
the number of visits for hypertension.
Measured: 6mth & 1yr
compliance with hypertensive medication use
Measured: 6month & 1yr
compliance with the intervention
Measured: 6month & 1yr
intensity of treatment
Measured: 6month & 1yr
frequency of lifestyle counseling by physician
Measured: 6month & 1yr
Quality of Life as measured by SF-36.
Measured: 6month & 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionApr 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Principal investigator, Dr. Richard Birtwhistle, Queen's University
- Investigators
- Marshall Godwin, MD MSc, Principal investigator, Queen's University, Kingston, Ontario, CanadaRichard Birtwhistle, MD MSc, Principal investigator, Queen's University, Kingston, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202137
- Sponsor's protocol ID
- HBPM
- Other IDs
- HSFO Grant # T-5345
- Status last verified
- Jan 2016
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003 Dec 22;3:28. doi: 10.1186/1471-2288-3-28.
PubMed 14690550Beckett L, Godwin M. The BpTRU automatic blood pressure monitor compared to 24 hour ambulatory blood pressure monitoring in the assessment of blood pressure in patients with hypertension. BMC Cardiovasc Disord. 2005 Jun 28;5(1):18. doi: 10.1186/1471-2261-5-18.
PubMed 15985180
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effects of Home Blood Pressure Monitoring on Blood Pressure Control
- ClinicalTrials.gov ID
- NCT00202137
- Acronym / sponsor ID
- HBPM
- Conditions
- Hypertension
- Keywords
- Home Blood Pressure, Hypertension, Blood Pressure Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jul 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- 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.
Hypertension is a common problem in Canada with a prevalence of about 15%. The goal of hypertension therapy should be to maximize blood pressure control. Home blood pressure monitoring (HBPM) devices are available and many patients are using them. The role that self-monitoring of blood pressure can play in optimizing blood pressure control is unclear. We hope to clarify the role of home blood pressure monitoring in the treatment of hypertension and explore how it may affect patient and physician behaviours related to blood pressure management. This study will compare a group of hypertensive patients who use HBPM with those who do not use these devices. The intervention (HBPM) group will measure their blood pressure at home a minimum of once weekly and will report these measurements to their family doctor at each visit. The control group will receive usual care as delivered by their family doctor. Outcomes of blood pressure control will be measured over a 12 month period. Outcomes will be determined primarily by 24 hour ambulatory blood pressure monitoring and by reviewing data in patient's charts located in family physicians office. Fifty family physicians from the Kingston area have agreed to participate.
Detailed description
The objective of this study is to measure the effect of home (self) blood pressure monitoring on control of hypertension in a primary care setting.
This research is important for several reasons:
- Lack of control of hypertension is common and is associated with morbidity and mortality. ii) The costs of managing hypertensions are high, not only because of the prevalence of hypertension, but also because maintenance of control must exist over many years for most patients. iii) Home blood pressure monitoring is increasingly being used by patients. iv) Guidelines for home blood pressure monitoring are already being developed and distributed.
- While it would seem helpful to increase self-care by patients, there is currently conflicting or inadequate evidence that home monitoring is useful.
The main hypothesis of the study is that, compared to patients who receive usual care, patients who use home monitoring will have lower blood pressure levels.
Our secondary hypothesis is that HBPM changes physician and patient behaviours in ways that would result in better control of hypertension.
The methodology uses cluster randomization. Physicians will be randomly allocated to either have their patients use the intervention or to continue with usual care. The intervention for the experimental group is the provision of a home blood pressure monitor to patients with a request that they record weekly blood pressure measurements and report them to their family physician at their regular hypertension follow-up visits. The physicians will be informed of current guidelines for target levels for home monitored blood pressure. The control group will receive usual care.
The main outcome measures will be blood pressure level (by 24 hour ambulatory monitoring) at baseline, 6 months and 12 months.
The secondary objective of this study is to measure the effect of home monitoring on physicians' and patients' behaviours related to hypertension control. Behaviours that will be measured include the intensity and type of pharmacological treatment, compliance with antihypertensive medication and changes in patient's lifestyle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Home blood pressure monitoringhome blood pressure monitoring with automatic blood pressure device |
| 2 | Active comparator | Behavioral: Physician monitoring of blood pressurephysician monitoring of blood pressure by 3 monthly office visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults age 18 years and older with essential hypertension.
- who are treated with medication to lower their blood pressure.
- whose mean daytime blood pressure at enrolment is 135/85 mm Hg or greater.
- and who are not currently using HBPM.
Key exclusion criteria (6 listed)
- a diagnosis of secondary hypertension.
- pregnancy.
- hypertension management primarily by a consultant.
- a disability that precludes use of a home blood pressure monitor.
- enrolled in another hypertension trial
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 |
|---|---|---|
| Home blood pressure monitoringMonitor blood pressure using home blood pressure monitor | Behavioural | 1 |
| Physician monitoring of blood pressureBlood pressure measured as standard care from physician (no home monitor given for blood pressure monitoring) | Behavioural | 2 |
Primary outcome
The mean nighttime blood pressures on ABPM.
Time frame: 6mth and 1yr
Achieving BP target at end of study
Time frame: 6mt and 1yr
7 secondary outcomes
patient lifestyle changes.
Time frame: 6mth and 1yr
the number of visits for hypertension.
Time frame: 6mth & 1yr
compliance with hypertensive medication use
Time frame: 6month & 1yr
compliance with the intervention
Time frame: 6month & 1yr
intensity of treatment
Time frame: 6month & 1yr
frequency of lifestyle counseling by physician
Time frame: 6month & 1yr
Quality of Life as measured by SF-36.
Time frame: 6month & 1yr
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 14 Jan 2016.
- Background: PubMed 14690550Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003 Dec 22;3:28. doi: 10.1186/1471-2288-3-28.
- Background: PubMed 15985180Beckett L, Godwin M. The BpTRU automatic blood pressure monitor compared to 24 hour ambulatory blood pressure monitoring in the assessment of blood pressure in patients with hypertension. BMC Cardiovasc Disord. 2005 Jun 28;5(1):18. doi: 10.1186/1471-2261-5-18.
- An article describing the methodologyLink provided by the sponsor.
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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.
Marshall Godwin, MD MSc principal investigator
Queen's University, Kingston, Ontario, Canada
Richard Birtwhistle, MD MSc principal investigator
Queen's University, Kingston, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home blood pressure monitoring and Physician monitoring of blood pressure in people with Hypertension, run by Queen's University 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 4 inclusion and 6 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 14 Jan 2016. 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 mean nighttime blood pressures on ABPM. (time frame: 6mth and 1yr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00202137, which also lists 2 linked publications.
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 14 Jan 2016.