Asthma
Conditions
Brief summary
This study is to compare Smart phone mobile device and/or web based application asthma action plan to the standard of care paper based asthma action plan within an asthma program. The Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice
Detailed description
This study is a multi-centre, randomized controlled trial comparing a web-based (Smart phone mobile device, tablet and/or personal computer PC) asthma action plan application to best practice/usual care within an asthma program. A third external comparator arm will compare participants to all patients with asthma in Ontario using data obtained from the Ontario Asthma Surveillance Information System (OASIS) cohort, created from administrative data sets within the Institute for Clinical Evaluative Sciences (ICES). Subjects will be randomly assigned in blocks of four, stratified by site to, in a ratio of 1:1 intervention or control arms. The study will enrol approximately 400 patients in total at all study sites.
Interventions
BEHAVIORALmobile & web-based action plan
Evidence-based best practice primary care asthma program including asthma self-management education replacing the written self-management action plan with the Breathe mobile health and web-based application
Sponsors
Ontario Lung Association
Ontario Ministry of Health and Long Term Care
TELUS
Canada Health Infoway
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of asthma * Age 18 of age or older * Familiar with web technology * Provide consent * Understand/read/write English
Exclusion criteria
\- Indication of other chronic lung diseases in the opinion of the physician that would impact their ability to participate in the trial or affect quality of life (Cystic Fibrosis, Chronic Obstructive Pulmonary Disease, Bronchiectasis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Outcome - Quality of Life | 6 months | Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality - Health Care Utilization | 1 year | Appropriateness of Care - Individuals with asthma who use the intervention will experience a decrease in the number of unplanned health system encounters |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Outcome - Quality | 1 year | Improvements in symptom profile greater than conventional best practice. |
| Health Outcome - Quality of Life | 6 months | Per protocol evaluation of the primary outcome, quality of life. It is anticipated that some subjects randomized to the intervention arm will not use the smartphone application. We seek to evaluate the primary outcome in those subjects who were adherent to the application compared to control subjects. |
Countries
Canada
Outcome results
None listed