Condition category
Circulatory System
Date applied
14/08/2003
Date assigned
08/09/2003
Last edited
18/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marshall Godwin

ORCID ID

Contact details

Centre for Studies in Primary Care
Dept of Family Medicine
220 Bagot Street
Kingston
Ontario
K7L 5E9
Canada
+1 613-549-4480
godwinm@post.queensu.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00202137

Protocol/serial number

NA 4882

Study information

Scientific title

Acronym

HBPM

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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)

Overall trial start date

01/07/2002

Overall trial end date

01/11/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

630

Participant 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

Recruitment start date

01/07/2002

Recruitment end date

01/11/2006

Locations

Countries of recruitment

Canada

Trial participating centre

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

Sponsor information

Organisation

Heart and Stroke Foundation of Ontario (Canada)

Sponsor details

1920 Yonge Street
4th Floor
Toronto
Ontario
M4S 3E2
Canada
+1 416 489 7100
mail@hsf.on.ca

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Heart and Stroke Foundation of Ontario (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14690550
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15985180

Publication citations

  1. Protocol

    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, 3, 28, doi: 10.1186/1471-2288-3-28.

  2. Results

    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, 5, 1, 18, doi: 10.1186/1471-2261-5-18.

Additional files

Editorial Notes