- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816216
Mobile Technology and Online Tools to Improve Asthma Control in Adolescents - Usability (CampAir FEA)
January 27, 2017 updated by: 3-C Institute for Social Development
Mobile Technology and Online Tools to Improve Asthma Control in Adolescents
This project will fully develop and preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control.
In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions.
Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents.
This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system.
This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.
Study Overview
Detailed Description
This project will fully develop and preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control.
In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions.
Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents.
This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system.
This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.
To ensure the software and website function as intended, investigators will systematically test each of the seven CampAir modules with target end users.
Participants will review one module per week for seven weeks.
As part of each module, participants will also complete a daily asthma checklist.
Following the review of each module, participants will be prompted to complete measures assessing technology acceptability and usability and product quality.
Results will be used to modify and finalize the user interface and navigation to maximize usability.
Results are expected to support that all participants find the CampAir product to be of high quality and technical acceptability.
Participants are expected to rate the usability and relevance of the CampAir product highly.
All participants are expected to advocate use of the product and recommend continued development and testing.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27713
- 3-C Institute for Social Development
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between ages 13 - 18 years
- Prior Asthma diagnosis
- Use of a prescribed Asthma medication in the past 12 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: End User Iterative Testing - CampAir
To ensure the software and website function as intended, investigators will systematically test each of the seven CampAir modules with target end users.
Participants will review one module per week for seven weeks.
As part of each module, participants will also complete a daily asthma checklist.
Following the review of each module, participants will be prompted to complete measures assessing technology acceptability and usability and product quality.
Results will be used to modify and finalize the user interface and navigation to maximize usability.
|
An empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Product Evaluation
Time Frame: Once per module (One Evaluation per week for seven weeks)
|
Participants will complete a brief online survey to rate the content modules and other components of the CampAir program in the areas of (a) engagement, (b) quality of content, (c) quality of flow, (d) value, (e) usefulness, (f) relevance to real-life, (g) usability.
Open-ended questions will also be included to gather qualitative comments and recommendations for each area assessed.
This measure will be repeated for each review with questions tailored to the particular components and modules reviewed.
|
Once per module (One Evaluation per week for seven weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Janey S McMillen, PhD, 3-C Institute for Social Development
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
October 5, 2016
Study Completion (Actual)
October 5, 2016
Study Registration Dates
First Submitted
June 22, 2016
First Submitted That Met QC Criteria
June 24, 2016
First Posted (Estimate)
June 28, 2016
Study Record Updates
Last Update Posted (Estimate)
January 30, 2017
Last Update Submitted That Met QC Criteria
January 27, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R44HL127826 Usability
- 5R44HL127826 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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