AsthmaAsthmaCareNCT02333630
Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
A study testing AsthmaCare mobile health application and Asthma education in people with Asthma, run by David Stukus.
Trial summary
The investigators aim to study the clinical efficacy of a mobile health application, AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel application developed by members of the study team that was previously studied in a pilot study of 21 children/teenagers 9-16 years old. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Asthma
- What is being tested?
- AsthmaCare mobile health application and Asthma education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Physician diagnosis of persistent asthma defined by treatment with at least one daily controller medication
- Fluent English speaking
- Subject must have access to an iOS or Android device in order to download and use the mobile health application
- At least one Emergency Department or Urgent Care visit due to asthma exacerbation in the 12 months prior to enrollment
Who cannot join
- No prescription/recommendation to use a daily controller medication
- Non-English speaking
- Lack of access to an iOS or Android device
- Current or prior use of AsthmaCare mobile health application at any time. Research assistant will assess by reviewing beforehand a complete list of people who have already downloaded the app
About this study
The investigators aim to study the clinical efficacy of a mobile health application, AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel application developed by members of the study team that was previously studied in a pilot study of 21 children/teenagers 9-16 years old. During the 30 day pilot study, there was universal usage and acceptance by all participants of this novel form of technology and asthma management. This current study aims to measure clinical outcomes for users of the app.
Read the detailed description
AsthmaCare is a novel mobile health application that integrates personalized asthma reminders with self management feedback. Users input their prescribed daily controller medications and personal asthma triggers upon first loading the app. Reminder messages are pushed through the device at predetermined times to take controller medications. Once daily push notifications are sent to the user regarding tips to avoid preselected asthma triggers.
Users are asked to input their use of controller medications, which is entered into a medication log. Every interaction will unlock reward points as gaming theory is integrated into AsthmaCare to maintain user engagement.
If symptoms occur or if rescue medication use is logged into AsthmaCare, the user is automatically directed to an interactive asthma self-management plan, aka written asthma treatment plan. When users are in the yellow zone, they receive notifications every 4 hours regarding symptom update or rescue medication use. When users are in the red zone, these notifications occur every 1 hour. When users are in the green zone (baseline, no symptoms), they will receive motivational messages every 24 hours to maintain engagement with the app as well as remind them to continue to use controller medications.
In addition to medication reminders and an interactive self-management plan, AsthmaCare provides links to the nearest National Pollen Bureau counting station and allows for symptom/medication diaries to be emailed for sharing with providers or printing.
Mobile health applications, particularly for asthma, have not been studies in prospective clinical trials to demonstrate ongoing user engagement or efficacy. This study aims to determine whether users of an asthma mobile health application will have superior clinical outcomes compared with traditional asthma management.
- Conditions
- Asthma
- Being tested
- AsthmaCare mobile health application, Asthma education
- Keywords
- asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsthmaCare mobile health applicationOther
Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
Asthma educationOther
A website with links to written asthma education and videos
| Study group | Role | What they receive |
|---|---|---|
| AsthmaCare intervention | Experimental | Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment. Receives: Other: AsthmaCare mobile health application |
| Control group | Active comparator | Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion. Receives: Other: Asthma education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Room Visits Secondary to Asthma Exacerbation
Number of emergency room visits for asthma 6 months following study enrollment and randomization
Measured: 6 months
Secondary outcomes (3)
Number of Asthma Exacerbations
Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
Measured: 6 months
Hospitalizations
Number of hospitalizations for asthma exacerbation during 6 month study duration
Measured: 6 months
Frequency of Use of the Mobile Health Application
Analytics from within the mobile application will be measured to determine the frequency and usage patterns of the mobile health application by users during the study period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Stukus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Stukus, Nationwide Children's Hospital
- Investigators
- David Stukus, M.D., Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333630
- Sponsor's protocol ID
- IRB14-00678
- Acronym
- AsthmaCare
- Status last verified
- Mar 2020
- First submitted
- 17 Dec 2014
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Martinez-Perez B, de la Torre-Diez I, Lopez-Coronado M. Mobile health applications for the most prevalent conditions by the World Health Organization: review and analysis. J Med Internet Res. 2013 Jun 14;15(6):e120. doi: 10.2196/jmir.2600.
PubMed 23770578Huckvale K, Car M, Morrison C, Car J. Apps for asthma self-management: a systematic assessment of content and tools. BMC Med. 2012 Nov 22;10:144. doi: 10.1186/1741-7015-10-144.
PubMed 23171675Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. doi: 10.1371/journal.pmed.1001362. Epub 2013 Jan 15.
PubMed 23349621Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.
PubMed 24282112Chan AH, Reddel HK, Apter A, Eakin M, Riekert K, Foster JM. Adherence monitoring and e-health: how clinicians and researchers can use technology to promote inhaler adherence for asthma. J Allergy Clin Immunol Pract. 2013 Sep-Oct;1(5):446-54. doi: 10.1016/j.jaip.2013.06.015. Epub 2013 Aug 30.
PubMed 24565615Stukus DR, Farooqui N, Strothman K, Ryan K, Zhao S, Stevens JH, Cohen DM. Real-world evaluation of a mobile health application in children with asthma. Ann Allergy Asthma Immunol. 2018 Apr;120(4):395-400.e1. doi: 10.1016/j.anai.2018.02.006. Epub 2018 Feb 13.
PubMed 29452259
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
- ClinicalTrials.gov ID
- NCT02333630
- Acronym / sponsor ID
- AsthmaCare / IRB14-00678
- Conditions
- Asthma
- Keywords
- asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- David StukusUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Posted 11 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to study the clinical efficacy of a mobile health application, AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel application developed by members of the study team that was previously studied in a pilot study of 21 children/teenagers 9-16 years old. During the 30 day pilot study, there was universal usage and acceptance by all participants of this novel form of technology and asthma management. This current study aims to measure clinical outcomes for users of the app.
Detailed description
AsthmaCare is a novel mobile health application that integrates personalized asthma reminders with self management feedback. Users input their prescribed daily controller medications and personal asthma triggers upon first loading the app. Reminder messages are pushed through the device at predetermined times to take controller medications. Once daily push notifications are sent to the user regarding tips to avoid preselected asthma triggers.
Users are asked to input their use of controller medications, which is entered into a medication log. Every interaction will unlock reward points as gaming theory is integrated into AsthmaCare to maintain user engagement.
If symptoms occur or if rescue medication use is logged into AsthmaCare, the user is automatically directed to an interactive asthma self-management plan, aka written asthma treatment plan. When users are in the yellow zone, they receive notifications every 4 hours regarding symptom update or rescue medication use. When users are in the red zone, these notifications occur every 1 hour. When users are in the green zone (baseline, no symptoms), they will receive motivational messages every 24 hours to maintain engagement with the app as well as remind them to continue to use controller medications.
In addition to medication reminders and an interactive self-management plan, AsthmaCare provides links to the nearest National Pollen Bureau counting station and allows for symptom/medication diaries to be emailed for sharing with providers or printing.
Mobile health applications, particularly for asthma, have not been studies in prospective clinical trials to demonstrate ongoing user engagement or efficacy. This study aims to determine whether users of an asthma mobile health application will have superior clinical outcomes compared with traditional asthma management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AsthmaCare intervention | Experimental | Other: AsthmaCare mobile health applicationParticipants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment. |
| Control group | Active comparator | Other: Asthma educationParticipants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Physician diagnosis of persistent asthma defined by treatment with at least one daily controller medication
- Fluent English speaking
- Subject must have access to an iOS or Android device in order to download and use the mobile health application
- At least one Emergency Department or Urgent Care visit due to asthma exacerbation in the 12 months prior to enrollment
Key exclusion criteria (4 listed)
- No prescription/recommendation to use a daily controller medication
- Non-English speaking
- Lack of access to an iOS or Android device
- Current or prior use of AsthmaCare mobile health application at any time. Research assistant will assess by reviewing beforehand a complete list of people who have already downloaded the app
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 |
|---|---|---|
| AsthmaCare mobile health applicationPersonalized, interactive mobile health application designed to send daily medication reminders and assist with self management | Other | AsthmaCare intervention |
| Asthma educationA website with links to written asthma education and videos | Other | Control group |
Primary outcome
Number of Emergency Room Visits Secondary to Asthma Exacerbation
Time frame: 6 months
Number of emergency room visits for asthma 6 months following study enrollment and randomization
3 secondary outcomes
Number of Asthma Exacerbations
Time frame: 6 months
Hospitalizations
Time frame: 6 months
Frequency of Use of the Mobile Health Application
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23770578Martinez-Perez B, de la Torre-Diez I, Lopez-Coronado M. Mobile health applications for the most prevalent conditions by the World Health Organization: review and analysis. J Med Internet Res. 2013 Jun 14;15(6):e120. doi: 10.2196/jmir.2600.
- Background: PubMed 23171675Huckvale K, Car M, Morrison C, Car J. Apps for asthma self-management: a systematic assessment of content and tools. BMC Med. 2012 Nov 22;10:144. doi: 10.1186/1741-7015-10-144.
- Background: PubMed 23349621Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. doi: 10.1371/journal.pmed.1001362. Epub 2013 Jan 15.
- Background: PubMed 24282112Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.
- Background: PubMed 24565615Chan AH, Reddel HK, Apter A, Eakin M, Riekert K, Foster JM. Adherence monitoring and e-health: how clinicians and researchers can use technology to promote inhaler adherence for asthma. J Allergy Clin Immunol Pract. 2013 Sep-Oct;1(5):446-54. doi: 10.1016/j.jaip.2013.06.015. Epub 2013 Aug 30.
- Derived from this study: PubMed 29452259Stukus DR, Farooqui N, Strothman K, Ryan K, Zhao S, Stevens JH, Cohen DM. Real-world evaluation of a mobile health application in children with asthma. Ann Allergy Asthma Immunol. 2018 Apr;120(4):395-400.e1. doi: 10.1016/j.anai.2018.02.006. Epub 2018 Feb 13.
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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.
David Stukus, M.D. principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing AsthmaCare mobile health application and Asthma education in people with Asthma, run by David Stukus.
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 4 inclusion and 4 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Emergency Room Visits Secondary to Asthma Exacerbation (time frame: 6 months). 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 NCT02333630, which also lists 6 linked publications.
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 11 Mar 2020.