Home Blood Pressure Monitoring and Blood Pressure Control - Full Text View

Sponsor:	Queen's University
Collaborator:	Heart and Stroke Foundation of Ontario
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00202137

Purpose

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.

Condition	Intervention
Hypertension	Behavioral: Home blood pressure monitoring Behavioral: Physician monitoring of blood pressure

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of the Effects of Home Blood Pressure Monitoring on Blood Pressure Control

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:

The mean nighttime blood pressures on ABPM. [ Time Frame: 6mth and 1yr ] [ Designated as safety issue: No ]
Achieving BP target at end of study [ Time Frame: 6mt and 1yr ] [ Designated as safety issue: No ]
Achieving 10% drop in the mean nighttime blood pressures [ Time Frame: 6mt & 1yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

patient lifestyle changes. [ Time Frame: 6mth and 1yr ] [ Designated as safety issue: No ]
the number of visits for hypertension. [ Time Frame: 6mth & 1yr ] [ Designated as safety issue: No ]
compliance with hypertensive medication use [ Time Frame: 6month & 1yr ] [ Designated as safety issue: No ]
compliance with the intervention [ Time Frame: 6month & 1yr ] [ Designated as safety issue: No ]
intensity of treatment [ Time Frame: 6month & 1yr ] [ Designated as safety issue: No ]
frequency of lifestyle counseling by physician [ Time Frame: 6month & 1yr ] [ Designated as safety issue: No ]
Quality of Life as measured by SF-36. [ Time Frame: 6month & 1yr ] [ Designated as safety issue: No ]

Enrollment:	597
Study Start Date:	July 2002
Study Completion Date:	June 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator home monitoring with blood pressure device	Behavioral: Home blood pressure monitoring Monitor blood pressure using home blood pressure monitor
2: No Intervention usual care only with physician for blood pressure monitoring.	Behavioral: Physician monitoring of blood pressure Blood pressure measured as standard care from physician (no home monitor given for blood pressure monitoring)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202137

Locations

Canada, Ontario
Centre for Studies in Primary Care
Kingston, Ontario, Canada, K7L 5E9

Sponsors and Collaborators

Queen's University

Heart and Stroke Foundation of Ontario

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

More Information

Additional Information:

An article describing the methodology This link exits the ClinicalTrials.gov site

Heart and Stroke Foundation of Canada This link exits the ClinicalTrials.gov site

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.

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.

Responsible Party:	Queen's University ( Dr M Godwin )
Study ID Numbers:	HBPM, HSFO Grant # T-5345
Study First Received:	September 13, 2005
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00202137 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

Home Blood Pressure, Hypertension, Blood Pressure Control

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010