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Trial record 39 of 661 for:    applied AND web-

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

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ClinicalTrials.gov Identifier: NCT01964469
Recruitment Status : Unknown
Verified January 2015 by Chris Licskai, Lawson Health Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : October 17, 2013
Last Update Posted : January 16, 2015
Sponsor:
Collaborators:
Ontario Lung Association
Ontario Ministry of Health and Long Term Care
TELUS
Canada Health Infoway
Information provided by (Responsible Party):
Chris Licskai, Lawson Health Research Institute

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

Condition or disease Intervention/treatment Phase
Asthma Behavioral: mobile & web-based action plan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)
Study Start Date : February 2013
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Written self-management action plan
Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review.
Experimental: mobile & web based action plan
Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application.
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

No Intervention: Administrative data set
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964469


Locations
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Canada, Ontario
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, N8H 1N8
St. Joseph's Hospital Asthma Clinic
London, Ontario, Canada
Sault St. Marie Group Health Centre
Sault St. Marie, Ontario, Canada
Windsor FHT
Windsor, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Ontario Lung Association
Ontario Ministry of Health and Long Term Care
TELUS
Canada Health Infoway
Investigators
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Principal Investigator: Christopher Licskai Lawson Health Research Institution

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chris Licskai, Associate Professor of Medicine, University of Western Ontario, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01964469     History of Changes
Other Study ID Numbers: 00000940
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases