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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20631056
Publication citations
-
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.