Using the internet to help individuals stay healthy and prevent further reductions in health from existing chronic diseases
| ISRCTN | ISRCTN77785397 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77785397 |
| Secondary identifying numbers | 246788 |
- Submission date
- 08/09/2011
- Registration date
- 08/11/2011
- Last edited
- 16/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
sara.ahmed@mcgill.ca
Contact information
Scientific
McGill University
3655 Promenade Sir William Osler
Montreal
H3G 1Y5
Canada
| sara.ahmed@mcgill.ca |
Study information
| Study design | Multicentre two-armed randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 objectives | 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(s) | McGill Faculty of Medicine Institutional Review Board (IRB), Canada 1 December 2010, ref: A08-M73-10B |
| Health condition(s) or problem(s) studied | Chronic Obstructive Pulmonary Disease (COPD) |
| Intervention | 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 | Other |
| Primary outcome measure | 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 study start date | 01/01/2012 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Canada
Study participating centre
Canada
Sponsor information
University/education
Faculty of Medicine
McIntyre Medical Building
3655 Promenade Sir William Osler
Montreal
H3G 1Y6
Canada
| researchsec.med@mcgill.ca | |
| Website | http://www.mcgill.ca/medicine/ |
"ROR" |
https://ror.org/01pxwe438 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
