Home Blood Pressure Monitoring and blood pressure (BP) control

ISRCTN	ISRCTN25105161
DOI	https://doi.org/10.1186/ISRCTN25105161
ClinicalTrials.gov (NCT)	NCT00202137
Protocol serial number	NA 4882
Sponsor	Heart and Stroke Foundation of Ontario (Canada)
Funder	Heart and Stroke Foundation of Ontario (Canada)

Submission date: 14/08/2003
Registration date: 08/09/2003
Last edited: 18/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marshall Godwin
Scientific

Centre for Studies in Primary Care
Dept of Family Medicine
220 Bagot Street
Kingston, Ontario
K7L 5E9
Canada

Phone	+1 613-549-4480
Email	godwinm@post.queensu.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	HBPM
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Hypertension
Intervention	Patients in the intervention group are provided with a home blood pressure monitor that they are to use at least once a week and report the BP measurements to their physician at each follow up visit.
Intervention type	Other
Primary outcome measure(s)	1. The mean daytime blood pressures on Ambulatory Blood Pressure Monitoring (ABPM) 2. The mean night-time blood pressures on ABPM 3. Achieving Blood Pressure (BP) target at end of study 4. Achieving 10% drop in the mean nighttime blood pressures
Key secondary outcome measure(s)	1. Patient lifestyle changes 2. The number of visits for hypertension 3. Compliance with hypertensive medication use 4. Compliance with the intervention 5. Intensity of treatment 6. Frequency of lifestyle counselling by physician 7. Quality of Life as measured by 36-item Short Form health survey (SF-36)
Completion date	01/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	630
Key inclusion criteria	1. Adults (age 18 and older) who are patients of family physicians 2. Must be diagnosed with essential hypertension but not have yet achieved target levels
Key exclusion criteria	1. A diagnosis of secondary hypertension 2. Pregnancy 3. Hypertension management primarily by a consultant 4. A disability that precludes use of a home blood pressure monitor 5. Enrolled in another hypertension trial 6. White coat hypertension
Date of first enrolment	01/07/2002
Date of final enrolment	01/11/2006

Locations

Countries of recruitment

Canada

Study participating centre

Centre for Studies in Primary Care

Kingston, Ontario
K7L 5E9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/06/2005		Yes	No
Protocol article	protocol	22/12/2003		Yes	No