Condition category
Circulatory System
Date applied
04/07/2014
Date assigned
24/07/2014
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Informing people of their risk of heart disease, along with counselling on what lifestyle choices should be adopted, is the first step towards preventing someone from developing the disease. Most Canadian physicians perform risk assessments on their patients as they are well aware of the importance of promoting regular physical activity. Despite this, 85% of adults in Canada do not meet Canada’s physical activity guidelines (which state that adults aged 18-64 should do at least 150 minutes of moderate to vigorous physical activity every week in bouts of 10 minutes or more). This highlights a need to prioritise counselling on physical activity, but time constraints may stop physicians from being able to do this for all their patients adequately. eHealth technology is an innovative way for helping patients to self-manage their heart disease health factors. It follows the same principles of face-to-face counselling by asking people about their health behaviour, their motivation and factors determining motivation and behaviour. The feedback given to a person is based on the answers given and highly tailored to meet each person’s individual needs. The aim of this study is to test the feasibility and efficacy of a web-based programme (the intervention) targeting physical activity in patients not reaching Canada’s physical activity guidelines.

Who can participate?
Participants aged between 35 and 70 years of age that took part in the Quebec City Prospective Urban Rural Epidemiology (PURE) study (a study looking at health among the local population)

What does the study involve?
Each participant is randomly allocated into one of two groups. The experimental group take part in a web-based physical activity program. Each session takes about 10-15 minutes each and participants are asked to do 8 sessions over the course of 16 minutes. The control group receive their usual standard of care. Both groups complete questionnaires before and after the experimental group have completed the physical activity programme. The programme will be offered to the control group once the study is complete.

What are the possible benefits and risks of participating?
The potential benefits for participants with this research project are:
1. Personalized advice regarding their own physical activity.
2. Knowledge that they have contributed to the advancement of knowledge in the field of promotion of physical activity on the Internet.
This research project has no known physical or psychological risks.

Where is the study run from?
1. Université du Québec à Trois-Rivières (Canada)
2. l’Institut universitaire de cardiologie et de pneumologie de Québec (Canada)

When is study starting and how long is it expected to run for?
April 2014 to September 2014

Who is funding the study?
The Canadian Institutes of Health Research (CIHR) (Canada)

Who is the main contact?
Professor François Boudreau
francois.boudreau@uqtr.ca

Trial website

http://www.purecybersante.ca/

Contact information

Type

Scientific

Primary contact

Prof Francois Boudreau

ORCID ID

Contact details

Université du Québec à Trois-Rivières
3351
boul. des Forges
C.P. 500
Trois-Rivières (Québec)
G9A 5H7
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

292463 (Canadian Institutes of Health Research)

Study information

Scientific title

Feasibility and efficacy of a computer-tailoring (CT) physical activity intervention to promote self management of cardiovascular disease (CVD) risk factors: a pilot randomized controlled trial

Acronym

PURE-Cybersanté-Activité Physique

Study hypothesis

To examine the feasibility of adapted Web-based CT intervention. The specific research question is:
Research Question 1. Do intervention initiation and intervention completion regarding PA differ in relation to socioeconomic status and gender?
To determine the efficacy of adapted Web-based CT intervention after three months. The specific research questions are:
RQ 2.1 - What is the efficacy of CT intervention on PA?
RQ-2.2 - Is the intervention equally effective for subgroups differing in socioeconomic status and gender?

Ethics approval

1. The ethics board of Université du Québec à Trois-Rivières; 16/07/2013; ref: CER-13-192-06.32
2. The ethics board of Institut universitaire de cardiologie et de pneumologie de Québec; 05/11/2013; ref: 21002

Study design

RCT. A design with baseline measurement (time 1) and follow-up measurement at three months.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular diseases

Intervention

Participants will be divided to 2 groups:
1. An experimental group (CT intervention): The intervention group will be invited to participate in eight 10-15 minute Web sessions distributed over a 16-week period
2. A control group (usual care): Will complete a pretest and a post-test. The intervention will be offered to the control group afterwards.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Leisure-time physical activity. The Godin Leisure-Time Physical Activity Questionnaire will be used : a validated French version will assess in both groups the average frequency of light, moderate, and vigorous exercise during free time in a typical week at baseline and 3-month follow-up. Also, forty participants in both groups will receive a blinded pedometer that has been validated. These participants will be instructed about how to wear pedometer correctly and physical activity behaviour will be measured during 7 consecutive days from morning to bedtime at 3-month follow-up.

Secondary outcome measures

N/A

Overall trial start date

28/05/2014

Overall trial end date

07/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Participants-inclusion criteria
1. Not meeting Canada’s physical activity guidelines of 150 minutes of moderate-vigorous physical activity a week
2. To be between 40 and 75 years of age
3. Have internet access.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

Participants-exclusion criteria:
1. A documented history of CVD at the time of the study
2. Poor mental function, drug or substance (e.g., alcohol) abuse, unstable psychiatric illness at the time of the study
3. Physical disability or other limitations reducing the ability to walk

Recruitment start date

28/05/2014

Recruitment end date

07/09/2014

Locations

Countries of recruitment

Canada

Trial participating centre

Université du Québec à Trois-Rivières
Trois-Rivières (Québec)
G9A 5H7
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (Canada)

Sponsor details

160 Elgin Street
9th Floor
Address Locator 4809A
Ottawa
K1A 0W9
Canada

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research (Canada) (e-Health Innovations Catalyst Grant-2012)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

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

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26453041

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.