Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2014-08-31
2017-12-31
Brief Summary
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The disease being studied is asthma. The main objective of this study is to assess the feasibility of the recruitment goals and also the logistical issues related to use of tele-health technology in developing electronic asthma action plan (eAAP) and communicate with asthma patients in a time period of 24 months. The goals are: 1) enable asthma patients to self-manage their asthma symptoms. The secondary, 2) help care providers to intervene appropriately based on the patient's health status. The secondary objective is to explore the cost-benefit and cost-effectiveness of the proposed technology. Our research group proposes to complete a feasibility study, with an interim analysis for a formal power calculation and then acquire ethics to report these results and study design with anticipated publication prior to proceeding with a full randomized controlled trial to assess the efficacy of this intervention. The outcome measure will be assessed and data will be presented in a 24-month time frame.
Aims and goals:
The main aim of our proposed study is to assist asthma patients to practice asthma self-management at home that will eventually enable them to control their asthma, and specifically, prevent asthma exacerbation. Therefore, the ultimate goal of our proposed study is to improve patient health outcome via enhancing patient-physician interaction and using a more practical asthma action plan model (eAAP) that could be followed easily by the patient and their doctor.
Our hypothesis is that asthma patients who have access to the electronic online action plan complimented by weekly text messages to reinforce adherence will have a reduced rate of asthma exacerbation. We further hypothesize that these subjects will have an improvement in secondary measures including quality of life, better asthma control and patient satisfaction. We also anticipate that such an approach in asthma management will be cost-effective as outlined below.
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Detailed Description
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This study will test the hypothesis that using mobile phone reminder messages and web-based monitoring, as part of a structured care plan, will improve clinical outcomes; namely reduction in the rate of exacerbation, in patients with asthma. We also aim to explore the cost-effectiveness of this technology. Our research group proposes to complete a feasibility study, with an interim analysis for a formal power calculation and then acquire ethics to report these results and study design with anticipated publication prior to proceeding with a full randomized controlled trial to assess the efficacy of this intervention. We predict that using a combination of Internet and SMS messaging technology will empower patients to manage their asthma and eventually prevent asthma exacerbation based on their personalized action plan as well as a SMS application. We plan to compare the web-based/SMS reminder method with written action plan approach in a 24-month time frame, as explained later in this proposal.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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SMS-Web eAAP group
electronic asthma action plan (eAAP) group
electronic asthma action plan (eAAP)
An electronic asthma action plan (eAAP) will be provided to intervention group
regular-care group
written asthma action plan (WAAP) group
written asthma action plan (WAAP)
A written asthma action plan will be given to control group arm
Interventions
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electronic asthma action plan (eAAP)
An electronic asthma action plan (eAAP) will be provided to intervention group
written asthma action plan (WAAP)
A written asthma action plan will be given to control group arm
Eligibility Criteria
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Inclusion Criteria
2. A history of an asthma exacerbation requiring oral corticosteroids or admission to Emergency Department/hospital in the previous year.
3. Ability to understand English and follow the material included in the two different interventions.
4. Ownership of a mobile phone with the capacity to support text messaging.
\-
Exclusion Criteria
2. A history of smoking cigarettes for greater than ten pack years.
3. Not owning a mobile cell phone.
4. Subjects only taking a reliever medication and on no controller medication.
5. A history of significant co morbid disease judged by the investigator to preclude enrolment.
6. A history of an asthma exacerbation requiring oral corticosteroids in the previous six weeks.
7. Plans to move out of the study area in the next year. -
19 Years
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Providence Health & Services
OTHER
University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Mark J FitzGerald, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada
Countries
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Related Links
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University of British Columbia Centre for Lung Health
Other Identifiers
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H13-02666
Identifier Type: -
Identifier Source: org_study_id
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