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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02816216
Other study ID # 5R44HL127826 Usability
Secondary ID 5R44HL127826
Status Completed
Phase N/A
First received June 22, 2016
Last updated January 27, 2017
Start date May 1, 2016
Est. completion date October 5, 2016

Study information

Verified date January 2017
Source 3-C Institute for Social Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 5, 2016
Est. primary completion date October 5, 2016
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- Between ages 13 - 18 years

- Prior Asthma diagnosis

- Use of a prescribed Asthma medication in the past 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States 3-C Institute for Social Development Durham North Carolina

Sponsors (3)

Lead Sponsor Collaborator
3-C Institute for Social Development Columbia University, New York University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Product Evaluation 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)
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