Condition category
Circulatory System
Date applied
15/03/2007
Date assigned
09/05/2007
Last edited
16/07/2010
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 Janusz Kaczorowski

ORCID ID

Contact details

Primary Care & Community Research at the Child & Family Research Institute
Suite 320
5950 University Boulevard
Department of Family Practice
University of British Columbia
Vancouver
V6T 1Z3
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06-482

Study information

Scientific title

Acronym

Study hypothesis

A patient information leaflet/booklet (based on the Canadian Hypertension Education Program [CHEP] Public Recommendations) and self-management tools (e.g. blood pressure 'tracker', medication diary, and lifestyle changes record) can impact on blood pressure related knowledge, attitudes, and behaviours among patients with elevated blood pressure in family practice.

Ethics approval

Final approval received from the Hamilton Health Sciences/McMaster University Faculty of Health Sciences Research Ethics Board on the 23rd January 2007 (ref: 04-682).

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Elevated blood pressure/hypertension

Intervention

This is a single-blind randomised controlled trial of a CHEP-based leaflet/booklet and interactive patient self-management tools, including a blood pressure tracker, for patients with hypertension compared with the usual family practice management and provision of the 2007 CHEP Public Recommendations.

Distribution of a patient information leaflet/booklet (based on the Canadian Hypertension Education Program (CHEP) Public Recommendations) and self-management tools (e.g. blood pressure 'tracker', medication diary, and lifestyle changes record).

Patients allocated to the control group will receive treatment as usual from their physician, with the addition of a copy of the Canadian Hypertension Education Program (CHEP) 2007 Public Recommendations.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in blood pressure related knowledge, attitudes, and behaviours among patients with elevated blood pressure in family practice.

Secondary outcome measures

Blood pressure will be measured in the family physicians office at baseline and exit visits.

Overall trial start date

01/04/2007

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients with elevated Blood Pressure (BP) (Systolic Blood Pressure [SBP] greater than 140 mmHg or greater than 130 mmHg if diabetic) who own or intend to purchase a home BP monitoring device
2. Patients will be either undergoing monitoring for a possible diagnosis of hypertension, or be uncontrolled hypertensives

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

Patients who do not own or intend to purchase a home BP monitoring device will be excluded

Recruitment start date

01/04/2007

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Primary Care & Community Research at the Child & Family Research Institute
Vancouver
V6T 1Z3
Canada

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

Department of Family Medicine
75 Frid Street
Hamilton
Ontario
L8P 4M3
Canada

Sponsor type

University/education

Website

http://www.mcmaster.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Hypertension Education Program (CHEP) (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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20631056

Publication citations

  1. Results

    Dawes MG, Kaczorowski J, Swanson G, Hickey J, Karwalajtys T, The effect of a patient education booklet and BP 'tracker' on knowledge about hypertension. A randomized controlled trial., Fam Pract, 2010, 27, 5, 472-478, doi: 10.1093/fampra/cmq048.

Additional files

Editorial Notes