- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202137
Home Blood Pressure Monitoring and Blood Pressure Control
A Randomized Controlled Trial of the Effects of Home Blood Pressure Monitoring on Blood Pressure Control
Study Overview
Status
Conditions
Intervention / Treatment
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:
i) 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.
v) 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 5E9
- Centre for Studies in Primary Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
home blood pressure monitoring with automatic blood pressure device
|
Monitor blood pressure using home blood pressure monitor
|
ACTIVE_COMPARATOR: 2
physician monitoring of blood pressure by 3 monthly office visits
|
Blood pressure measured as standard care from physician (no home monitor given for blood pressure monitoring)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The mean nighttime blood pressures on ABPM.
Time Frame: 6mth and 1yr
|
6mth and 1yr
|
Achieving BP target at end of study
Time Frame: 6mt and 1yr
|
6mt and 1yr
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
patient lifestyle changes.
Time Frame: 6mth and 1yr
|
6mth and 1yr
|
the number of visits for hypertension.
Time Frame: 6mth & 1yr
|
6mth & 1yr
|
compliance with hypertensive medication use
Time Frame: 6month & 1yr
|
6month & 1yr
|
compliance with the intervention
Time Frame: 6month & 1yr
|
6month & 1yr
|
intensity of treatment
Time Frame: 6month & 1yr
|
6month & 1yr
|
frequency of lifestyle counseling by physician
Time Frame: 6month & 1yr
|
6month & 1yr
|
Quality of Life as measured by SF-36.
Time Frame: 6month & 1yr
|
6month & 1yr
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marshall Godwin, MD MSc, Queen's University, Kingston, Ontario, Canada
- Principal Investigator: Richard Birtwhistle, MD MSc, Queen's University, Kingston, Ontario, Canada
Publications and helpful links
General 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.
- Beckett 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBPM
- HSFO Grant # T-5345 (OTHER_GRANT: Ontario Heart and Stroke Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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