NCT00202137

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

4.8 years

First QC Date

September 13, 2005

Last Update Submit

January 13, 2016

Conditions

Hypertension

Keywords

Home Blood Pressure, Hypertension, Blood Pressure Control

Outcome Measures

Primary Outcomes (2)

  • The mean nighttime blood pressures on ABPM.

    6mth and 1yr

  • Achieving BP target at end of study

    6mt and 1yr

Secondary Outcomes (7)

  • patient lifestyle changes.

    6mth and 1yr

  • the number of visits for hypertension.

    6mth & 1yr

  • compliance with hypertensive medication use

    6month & 1yr

  • compliance with the intervention

    6month & 1yr

  • intensity of treatment

    6month & 1yr

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

home blood pressure monitoring with automatic blood pressure device

Behavioral: Home blood pressure monitoring

2

ACTIVE COMPARATOR

physician monitoring of blood pressure by 3 monthly office visits

Behavioral: Physician monitoring of blood pressure

Interventions

Home blood pressure monitoringBEHAVIORAL

Monitor blood pressure using home blood pressure monitor

1
Physician monitoring of blood pressureBEHAVIORAL

Blood pressure measured as standard care from physician (no home monitor given for blood pressure monitoring)

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Studies in Primary Care

Kingston, Ontario, K7L 5E9, Canada

Location

Related Publications (2)

  • 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.

    PMID: 14690550BACKGROUND

  • 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.

    PMID: 15985180BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Marshall Godwin, MD MSc

    Queen's University, Kingston, Ontario, Canada

    PRINCIPAL INVESTIGATOR

  • Richard Birtwhistle, MD MSc

    Queen's University, Kingston, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2002

Primary Completion

April 1, 2007

Study Completion

June 1, 2007

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

CA(1)