Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One of the greatest healthcare challenges is the increasing costs and social burden of chronic disease - a challenge which the healthcare system is poorly equipped to address. Self-management refers to learning and practicing skills necessary to carry on an active and emotionally satisfying life in the face of a chronic condition. This requires providing patients with tools and strategies to manage their health and to develop the confidence needed to take up healthy behaviors and stop unhealthy ones. Unfortunately, the support provided by the healthcare system to help individuals manage their health has mainly involved a combination of infrequent brief discussions during physician visits and educational pamphlets, but has not provided the patient with ongoing information and monitoring in response to changes in their health. Self-management support for patients by the care team is recognized as an integral element needed for improving health outcomes by guiding individuals to care for their own health and to make positive health choices. To provide this type of support a direct line of communication is required between the patient and care team, extending the care experience outside of the physician’s office or clinic. Health information technology (HIT) offers a unique opportunity to provide regular monitoring by supplying a means for two-way communication and exchange of information between the patient and care team. Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in Canada and is one condition where self-management has been shown to be effective for improving health outcomes. This study will evaluate the acceptability and test the effects of using a COPD web-based self-management tool on selected health behaviors and outcomes.

Who can participate?
Patients aged 40 and over with stable COPD .

What does the study involve?
Participants will be randomly allocated to either the intervention group or the control group. Both groups will receive usual care, which includes being managed by their respective specialists or general practitioners and receiving the Living Well with COPD program. In addition to usual care, the intervention group will also get access to the COPD web-based self-management tool.

What are the possible benefits and risks of participating?
If the tool is found to be effective, it will be deployed and further tested on a larger scale and adapted for other chronic diseases. Other than the time required for this study, there is no direct disadvantage or risk to health by participating in this study.

Where is the study run from?
Montreal Chest Institute, Sacre Coeur Hospital, Montreal, Canada.

When is the study starting and how long is it expected to run for?
From January 2012 to December 2013.

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

Who is the main contact?
Dr Sara Ahmed

Trial website

Contact information



Primary contact

Dr Sara Ahmed


Contact details

McGill University
3655 Promenade Sir William Osler
H3G 1Y5

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Maximizing the effects of self-management interventions on chronic disease outcomes: the development of a Chronic Obstructive Pulmonary Disease (COPD) web-based patient portal


Study hypothesis

Higher rates of usage of the web-based tool will be associated with:
1. Greater improvements in COPD action plan adherence in the event of an exacerbation
2. Reduced nurse case manager work load

Ethics approval

McGill Faculty of Medicine Institutional Review Board (IRB), Canada 1 December 2010, ref: A08-M73-10B

Study design

Multicentre two-armed randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

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


Chronic Obstructive Pulmonary Disease (COPD)


Intervention group:
In addition to usual care, access to the COPD web-based self-management system including educational COPD content, personal medical information such demographic, drug and medical visit information.

Control group:
Usual care

Duration: 12 months

Intervention type



Not Applicable

Drug names

Primary outcome measures

1. Improvement in patients' adherence to action plan in the event of exacerbation
2. Action plan adherence defined as the patient taking antibiotic or prednisolone within three days of starting an acute exacerbation

Secondary outcome measures

1. Medication adherence
2. COPD self-efficacy
3. COPD specific health-related quality of life (chronic respiratory questionnaire, St George's respiratory questionnaire)
4. Adverse events (number of respiratory emergency deparment visits and hospitalisations)

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Males and females patients with stable COPD aged 40 years and older
2. Patients who started the "Living Well with COPD" program
3. Have access to a computer and internet
4. Current or previous smoker (at least 10 packs per year)
5. Forced expiratory volume in 1 second (FEV1) after the use of a bronchodilator between 25% and 70% of the predicted normal value and FEV1 - forced vital capacity ratio less than 70%
6. Two COPD exacerbations in the previous year

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Previous diagnosis of asthma
2. Left congestive heart failure
3. Terminal disease
4. Dementia
5. Uncontrolled psychiatric illness
6. Long term care-facility stays

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Montreal Chest Institute

Sponsor information


McGill University (Canada)

Sponsor details

Faculty of Medicine
McIntyre Medical Building
3655 Promenade Sir William Osler
H3G 1Y6

Sponsor type




Funder type


Funder name

Canadian Institutes of Health Research, ref: MOP - 115082 (Canada)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government



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

Publication citations

Additional files

Editorial Notes