Clinical trial NCT01964469: Consumer Access to Personal Health Information for Asthma Self-Management
Official title: Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Lung Association
name: Ontario Ministry of Health and Long Term Care
name: TELUS
name: Canada Health Infoway
First posted: 2013-10-17
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Health Outcome - Quality of Life
timeFrame: 6 months
Secondary outcomes:
measure: Quality - Health Care Utilization
timeFrame: 1 year
Other outcomes:
measure: Health Outcome - Quality
timeFrame: 1 year
measure: Health Outcome - Quality of Life
timeFrame: 6 months
Locations:
city: Amherstburg
country: Canada
facility: Amherstburg FHT
state: Ontario
city: Chatham
country: Canada
facility: Chatham-Kent FHT
state: Ontario
city: Harrow
country: Canada
facility: Harrow FHT
state: Ontario
city: Kingston
country: Canada
facility: Kingston Hospital Asthma Clinic
state: Ontario
city: Leamington
country: Canada
facility: Leamington FHT
state: Ontario
city: London
country: Canada
facility: St. Joseph's Hospital Asthma Clinic
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Sault St. Marie Group Health Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor FHT
state: Ontario
Study officials:
affiliation: Lawson Health Research Institution
name: Christopher Licskai
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.