AsthmaNCT03930381
Adapting and Expanding the Asthma-Educator App
A study testing ASTHMAXcel App in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app. Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- Asthma
- What is being tested?
- ASTHMAXcel App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Jul 2023
- 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 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English-speaking individuals between 15-21
- 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: Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.
Read the detailed description
The study will test the adapted app on participants ages 15-21 (recruited from outpatient primary and specialty care sites at Montefiore) with asthma, for a period of 4 and a half months, and will conduct formative and summative evaluation of the application's functionality and usability. The investigators will also be collecting process and clinical outcomes.
- Conditions
- Asthma
- Being tested
- ASTHMAXcel App
- 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.
ASTHMAXcel AppOther
ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | This group will download the ASTHMAXcel application and use it for the duration of the study Receives: Other: ASTHMAXcel App |
| Usual Care Arm | No intervention | This group will just receive normal provider care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Asthma Control to 3 Month Asthma Control
Asthma symptom burden as measured by the Asthma Control Test
Score Scale: 5 (min = worse); 25 (max = better outcome)
Measured: Post-Refinement Baseline, 3 Months
Change from Baseline Asthma Control to 3 Month Asthma Control
Asthma symptom burden as measured by the Asthma Control Test
Score Scale: 5 (min = worse); 25 (max = better outcome)
Measured: Post-Refinement Baseline, 4 Months
Secondary outcomes (9)
Asthma Symptom Perception
Ability of participants to perceive their asthma symptoms by using the ASTHMAXcel app and a peak flowmeter
Measured: Week 2, Week 4 , Week 6 (Pre and Post Refinement)
Asthma Knowledge
Will use the Child Asthma Illness Representation Survey (AIRS) to asses patients knowledge on asthma as well as their attitudes towards their condition.
Score Scale: 4 (min = worse outcome); 20 (max = better outcome)
Measured: Post-Refinement Baseline, 3 Month
Medication Adherence
Self-reported adherence by patient using Medication Adherence Report Scale
Score Scale: 10 (min = worse outcome); 50 (max = better outcome)
Measured: Post-Refinement Baseline, 3 Month
Asthma Quality of Life
Quality of life of participants, measured by mini-Asthma Quality of Life Questionnaire
Score Scale: 15 (min = worse outcome); 105 (max = better outcome)
Measured: Post-Refinement Baseline, 3 Month
Emergency Department Visits
Self-Reported Emergency Department (ED) visits
Measured: Post-Refinement Baseline, 3 Month
Patient Satisfaction
Patient satisfaction with study measured by the Client Satisfaction Questionnaire-8
Score Scale: 8 (min = worse outcome); 32 (max = better outcome)
Measured: Post-Refinement Baseline, 3 Month
Patient Interface Satisfaction
Patient satisfaction with ASTHMAXcel app interface measured by Questionnaire for User Interface Survey (QUIS)
Score Scale: 0 (min = worse outcome); 261 (max = better outcome)
Answers scale from 0 (terrible/hard to understand)) to 9 (wonderful/easy to understand)
Measured: Post-Refinement Baseline, 3 Month
Patient Usage
Time spent on app and different screens of app, measured using Google Analytics
Measured: Baseline, 3 Month
Health Literacy
Ability for patients to comprehend Newest Vital Sign screening tool
Measured: Post-Refinement Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 May 2018
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
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
- Randomised
- Intervention model
- Single group
- Model description
- Study will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual Care
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT03930381
- Sponsor's protocol ID
- 2018-9083
- Status last verified
- Jul 2023
- First submitted
- 5 Apr 2019
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
PubMed 35691614
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
- ClinicalTrials.gov ID
- NCT03930381
- Acronym / sponsor ID
- 2018-9083
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Apr 2019 (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 test and refine an adapted/expanded version of a previously created ASTHMAXcel app.
Detailed description
The study will test the adapted app on participants ages 15-21 (recruited from outpatient primary and specialty care sites at Montefiore) with asthma, for a period of 4 and a half months, and will conduct formative and summative evaluation of the application's functionality and usability. The investigators will also be collecting process and clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual Care
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: ASTHMAXcel AppThis group will download the ASTHMAXcel application and use it for the duration of the study |
| Usual Care Arm | No intervention | –This group will just receive normal provider care |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- English-speaking individuals between 15-21
- 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 |
|---|---|---|
| ASTHMAXcel AppASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management. | Other | Intervention Arm |
Primary outcome
Change from Baseline Asthma Control to 3 Month Asthma Control
Time frame: Post-Refinement Baseline, 3 Months
Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)
Change from Baseline Asthma Control to 3 Month Asthma Control
Time frame: Post-Refinement Baseline, 4 Months
Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)
9 secondary outcomes
Asthma Symptom Perception
Time frame: Week 2, Week 4 , Week 6 (Pre and Post Refinement)
Asthma Knowledge
Time frame: Post-Refinement Baseline, 3 Month
Medication Adherence
Time frame: Post-Refinement Baseline, 3 Month
Asthma Quality of Life
Time frame: Post-Refinement Baseline, 3 Month
Emergency Department Visits
Time frame: Post-Refinement Baseline, 3 Month
Patient Satisfaction
Time frame: Post-Refinement Baseline, 3 Month
Patient Interface Satisfaction
Time frame: Post-Refinement Baseline, 3 Month
Patient Usage
Time frame: Baseline, 3 Month
Health Literacy
Time frame: Post-Refinement Baseline
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 27 Jul 2023.
- Derived from this study: PubMed 35691614Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
- Individual participant dataSharing planned: No
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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 ASTHMAXcel App 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 5 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 27 Jul 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 3 Month Asthma Control (time frame: Post-Refinement Baseline, 3 Months). The study lists 2 primary outcomes in all. 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 NCT03930381, 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 27 Jul 2023.