Consumer Access to Personal Health Information for Asthma Self-Management (ASMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01964469|
Recruitment Status : Unknown
Verified January 2015 by Chris Licskai, Lawson Health Research Institute.
Recruitment status was: Active, not recruiting
First Posted : October 17, 2013
Last Update Posted : January 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: mobile & web-based action plan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||March 2016|
Placebo Comparator: 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.
Experimental: 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.
Behavioral: 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: 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.
- 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.
- Quality - Health Care Utilization [ Time Frame: 1 year ]Appropriateness of Care - Individuals with asthma who use the intervention will experience a decrease in the number of unplanned health system encounters
- Health Outcome - Quality [ Time Frame: 1 year ]Improvements in symptom profile greater than conventional best practice.
- Health Outcome - Quality of Life [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964469
|Amherstburg, Ontario, Canada|
|Chatham, Ontario, Canada|
|Harrow, Ontario, Canada|
|Kingston Hospital Asthma Clinic|
|Kingston, Ontario, Canada|
|Leamington, Ontario, Canada, N8H 1N8|
|St. Joseph's Hospital Asthma Clinic|
|London, Ontario, Canada|
|Sault St. Marie Group Health Centre|
|Sault St. Marie, Ontario, Canada|
|Windsor, Ontario, Canada|
|Principal Investigator:||Christopher Licskai||Lawson Health Research Institution|