Consumer Access to Personal Health Information for Asthma Self-Management

Asthma Clinical Trial

— ASMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964469
• Other study ID #: 00000940
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: March 2016

Study information

• Verified date: August 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: March 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Canada	Amherstburg FHT	Amherstburg	Ontario
Canada	Chatham-Kent FHT	Chatham	Ontario
Canada	Harrow FHT	Harrow	Ontario
Canada	Kingston Hospital Asthma Clinic	Kingston	Ontario
Canada	Leamington FHT	Leamington	Ontario
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

Sponsors (5)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canada Health Infoway, Ontario Lung Association, Ontario Ministry of Health and Long Term Care, TELUS

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Outcome - Quality	Improvements in symptom profile greater than conventional best practice.	1 year
Other	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.	6 months
Primary	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	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