Consumer Access to Personal Health Information for Asthma Self-Management (ASMA)

Lawson Health Research Institute

Status: Completed

Conditions: Asthma

Treatments: Behavioral: mobile & web-based action plan

Study type: Interventional

Funder types: Other

Identifiers

NCT01964469

00000940

Details and patient eligibility

About

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

Full 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.

Enrollment: 344 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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344 participants in 3 patient groups, including a placebo group

Written self-management action plan

Placebo Comparator group

Description:

Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review.

Treatment:

Behavioral: mobile & web-based action plan

mobile & web based action plan

Experimental group

Description:

Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application.

Treatment:

Behavioral: mobile & web-based action plan

Administrative data set

No Intervention group

Description:

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.