Consumer Access to Personal Health Information for Asthma Self-Management

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.

Official Title
-----------------
Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: mobile & web-based action plan


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Written self-management action plan<br>Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review. | Behavioral: mobile & web-based action plan<br>* 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<br>|
| Experimental: mobile & web based action plan<br>Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application. | Behavioral: mobile & web-based action plan<br>* 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<br>|
| No Intervention: Administrative data set<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Outcome - Quality of Life | Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality - Health Care Utilization | Appropriateness of Care - Individuals with asthma who use the intervention will experience a decrease in the number of unplanned health system encounters | 1 year |