AsthmaCampAir FEANCT02816216
Mobile Technology and Online Tools to Improve Asthma Control in Adolescents - Usability
A study testing CampAir in people with Asthma, run by 3-C Institute for Social Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- CampAir
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 5 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between ages 13 - 18 years
- Prior Asthma diagnosis
- Use of a prescribed Asthma medication in the past 12 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
3-C Institute for Social Development
Durham, North Carolina, 27713
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- CampAir
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CampAirBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| End User Iterative Testing - CampAir | Other | 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. Receives: Behavioral: CampAir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once per module (One Evaluation per week for seven weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start1 May 2016
- Primary completion5 Oct 2016
- Study completion5 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, New York University
- Responsible party
- Sponsor
- Investigators
- Janey S McMillen, PhD, Principal investigator, 3-C Institute for Social Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816216
- Sponsor's protocol ID
- 5R44HL127826 Usability
- Other IDs
- 5R44HL127826
- Acronym
- CampAir FEA
- Status last verified
- Jan 2017
- First submitted
- 22 Jun 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bruzzese JM, George M, Liu J, Evans D, Naar S, DeRosier ME, Thomas JM. The Development and Preliminary Impact of CAMP Air: A Web-based Asthma Intervention to Improve Asthma Among Adolescents. Patient Educ Couns. 2021 Apr;104(4):865-870. doi: 10.1016/j.pec.2020.09.011. Epub 2020 Sep 15.
PubMed 33004234
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Technology and Online Tools to Improve Asthma Control in Adolescents
- ClinicalTrials.gov ID
- NCT02816216
- Acronym / sponsor ID
- CampAir FEA / 5R44HL127826 Usability
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Columbia University, New York University
- Study start
- 1 May 2016 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 5 Oct 2016 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End User Iterative Testing - CampAir | Other | Behavioral: CampAirTo 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Between ages 13 - 18 years
- Prior Asthma diagnosis
- Use of a prescribed Asthma medication in the past 12 months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CampAirAn 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. | Behavioural | End User Iterative Testing - CampAir |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 33004234Bruzzese JM, George M, Liu J, Evans D, Naar S, DeRosier ME, Thomas JM. The Development and Preliminary Impact of CAMP Air: A Web-based Asthma Intervention to Improve Asthma Among Adolescents. Patient Educ Couns. 2021 Apr;104(4):865-870. doi: 10.1016/j.pec.2020.09.011. Epub 2020 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janey S McMillen, PhD principal investigator
3-C Institute for Social Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CampAir in people with Asthma, run by 3-C Institute for Social Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product Evaluation (time frame: Once per module (One Evaluation per week for seven weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.