Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 344
- Locations
- 8
- Primary Endpoint
- Health Outcome - Quality of Life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Written self-management action plan
Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review.
Intervention: mobile & web-based action plan (Behavioral)
mobile & web based action plan
Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application.
Intervention: mobile & web-based action plan (Behavioral)
Administrative data set
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.
Outcomes
Primary Outcomes
Health Outcome - Quality of Life
Time Frame: 6 months
Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice.
Secondary Outcomes
- Quality - Health Care Utilization(1 year)
Investigators
Chris Licskai
Associate Professor of Medicine, University of Western Ontario
Lawson Health Research Institute