This trial is active, not recruiting.

Condition asthma
Treatment mobile & web-based action plan
Sponsor Lawson Health Research Institute
Collaborator Ontario Lung Association
Start date February 2013
End date June 2014
Trial size 400 participants
Trial identifier NCT01964469, 00000940


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review.
Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application.
mobile & 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
(No Intervention)
Health services use will be evaluated comparatively against our intervention population and our control and we will include health services utilization data from one year prior randomization.

Primary Outcomes

Health Outcome - Quality of Life
time frame: 6 months

Secondary Outcomes

Quality - Health Care Utilization
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)
Principal investigator Christopher Licskai
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.