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| Name | Class |
|---|---|
| Ontario Lung Association | OTHER |
| Ontario Ministry of Health and Long Term Care | OTHER_GOV |
| TELUS | UNKNOWN |
| Canada Health Infoway |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Written self-management action plan | Placebo Comparator | Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review. |
|
| mobile & web based action plan | Experimental | Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application. |
|
| Administrative data set | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile & web-based action plan | Behavioral | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health Outcome - Quality | Improvements in symptom profile greater than conventional best practice. | 1 year |
| Health Outcome - Quality of Life | 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. |
Inclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Licskai | Lawson Health Research Institution | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amherstburg FHT | Amherstburg | Ontario | Canada | |||
| Chatham-Kent FHT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30688654 | Derived | Morita PP, Yeung MS, Ferrone M, Taite AK, Madeley C, Stevens Lavigne A, To T, Lougheed MD, Gupta S, Day AG, Cafazzo JA, Licskai C. A Patient-Centered Mobile Health System That Supports Asthma Self-Management (breathe): Design, Development, and Utilization. JMIR Mhealth Uhealth. 2019 Jan 28;7(1):e10956. doi: 10.2196/10956. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 27, 2020 | |
| Reset | Apr 13, 2020 | |
| Release | Apr 22, 2020 | |
| Reset | May 15, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2020 | Apr 13, 2020 | |||
| Apr 22, 2020 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| OTHER |
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| 6 months |
| Chatham |
| Ontario |
| Canada |
| Harrow FHT | Harrow | Ontario | Canada |
| Kingston Hospital Asthma Clinic | Kingston | Ontario | Canada |
| Leamington FHT | Leamington | Ontario | N8H 1N8 | Canada |
| St. Joseph's Hospital Asthma Clinic | London | Ontario | Canada |
| Sault St. Marie Group Health Centre | Sault Ste. Marie | Ontario | Canada |
| Windsor FHT | Windsor | Ontario | Canada |
| May 15, 2020 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |