AsthmaNCT03520881
Pediatric ASTHMA-Educator
A study testing Pediatric ASTHMA-Educator mobile application in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Pediatric ASTHMA-Educator mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 1 Jul 2021
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- English-speaking individuals between 7-17 years with:
- Persistent asthma (diagnosis made by a healthcare provider) on a daily controller medication
- Able to give informed consent
- Smartphone (iOS or Android) access
Who cannot join
- Use of oral corticosteroids in the 2 weeks prior to the baseline visit
- Pregnancy
- Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
- Patients that previously received the ASTHMA-Educator application
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: The Development and Pilot Testing of a Pediatric Algorithmic Software Tool to Help Manage Asthma (ASTHMA)-Educator
This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.
Read the detailed description
This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application. The study is being conducted at Montefiore Medical Center among pediatric (7-17 years old) patients with persistent asthma. We are collecting process and clinical outcomes in a longitudinal study design.
- Conditions
- Asthma
- Being tested
- Pediatric ASTHMA-Educator mobile application
- 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.
Pediatric ASTHMA-Educator mobile applicationOther
This intervention represents a mobile application (accessible by iOS and Android devices) that provides asthma education through games and videos.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric ASTHMA-Educator arm | Experimental | This arm corresponds to the pediatric version of the ASTHMA-Educator mobile application. Receives: Other: Pediatric ASTHMA-Educator mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline asthma control to 2, 4, and 6 months
Asthma symptom burden as measured by the Asthma Control Test
Measured: Baseline, 2 months, 4 months, 6 months
Secondary outcomes (7)
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Measured: Baseline, 2 months, 4 months, 6 months
Change from baseline asthma knowledge to 2 months, 4 months, 6 months
Asthma knowledge as measured by the Asthma Knowledge Questionnaire
Measured: Baseline, 2 months, 4 months, 6 months
Asthma quality of life as measured by the Pediatric Asthma Impact Scale
Patient's asthma quality of life measured by the Pediatric Asthma Impact Scale
Measured: Baseline, 2 months, 4 months, 6 months
Self-reported medication adherence
Patients' self-reported medication adherence measured by the Medication Adherence Rating Scale
Measured: Baseline, 2 months, 4 months, 6 months
Asthma emergency department visits
Asthma emergency department visits
Measured: Baseline, 2 months, 4 months, 6 months
Asthma hospitalizations
Asthma hospitalizations
Measured: Baseline, 2 months, 4 months, 6 months
Asthma-related steroid courses
Asthma-related steroid courses
Measured: Baseline, 2 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jul 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- There is one group (intervention arm only) in this proof of concept study.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunit Jariwala, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520881
- Sponsor's protocol ID
- 2013-2693A
- Status last verified
- Jun 2023
- First submitted
- 13 Apr 2018
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share aggregated and deidentified data in the form of abstracts and publications.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Pilot Testing of a Pediatric Algorithmic Software Tool to Help Manage Asthma (ASTHMA)-Educator
- ClinicalTrials.gov ID
- NCT03520881
- Acronym / sponsor ID
- 2013-2693A
- Conditions
- Asthma
- Keywords
- asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 11 May 2018 (actual)
- 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 seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.
Detailed description
This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application. The study is being conducted at Montefiore Medical Center among pediatric (7-17 years old) patients with persistent asthma. We are collecting process and clinical outcomes in a longitudinal study design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is one group (intervention arm only) in this proof of concept study.
| Arm | Type | Receives |
|---|---|---|
| Pediatric ASTHMA-Educator arm | Experimental | Other: Pediatric ASTHMA-Educator mobile applicationThis arm corresponds to the pediatric version of the ASTHMA-Educator mobile application. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Persistent asthma (diagnosis made by a healthcare provider) on a daily controller medication
- Able to give informed consent
- Smartphone (iOS or Android) access
Key exclusion criteria (4 listed)
- Use of oral corticosteroids in the 2 weeks prior to the baseline visit
- Pregnancy
- Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
- Patients that previously received the ASTHMA-Educator application
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 |
|---|---|---|
| Pediatric ASTHMA-Educator mobile applicationThis intervention represents a mobile application (accessible by iOS and Android devices) that provides asthma education through games and videos. | Other | Pediatric ASTHMA-Educator arm |
Primary outcome
Change from baseline asthma control to 2, 4, and 6 months
Time frame: Baseline, 2 months, 4 months, 6 months
Asthma symptom burden as measured by the Asthma Control Test
7 secondary outcomes
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Time frame: Baseline, 2 months, 4 months, 6 months
Change from baseline asthma knowledge to 2 months, 4 months, 6 months
Time frame: Baseline, 2 months, 4 months, 6 months
Asthma quality of life as measured by the Pediatric Asthma Impact Scale
Time frame: Baseline, 2 months, 4 months, 6 months
Self-reported medication adherence
Time frame: Baseline, 2 months, 4 months, 6 months
Asthma emergency department visits
Time frame: Baseline, 2 months, 4 months, 6 months
Asthma hospitalizations
Time frame: Baseline, 2 months, 4 months, 6 months
Asthma-related steroid courses
Time frame: Baseline, 2 months, 4 months, 6 months
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 8 Jun 2023.
- Individual participant dataSharing planned: Yes. We will share aggregated and deidentified data in the form of abstracts and publications.
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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.
Sunit Jariwala, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric ASTHMA-Educator mobile application in people with Asthma, run by Montefiore Medical Center 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 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 8 Jun 2023. 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?
Change from baseline asthma control to 2, 4, and 6 months (time frame: Baseline, 2 months, 4 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2023.