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OpenTrials
Completed

NCT Number: NCT01964469

Consumer Access to Personal Health Information for Asthma Self-Management

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amherstburg FHT, Amherstburg, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. Health Outcome - Quality

    Time frame: 1 year

    Improvements in symptom profile greater than conventional best practice.

  2. 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.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Canada Health Infoway
  • Ontario Lung Association
  • Ontario Ministry of Health and Long Term Care
  • TELUS

Registry information

Official study title

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

Acronym: ASMA

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Oct 17, 2013
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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