AsthmaNCT02426814
Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
A study testing Inhaler sensor and Mobile application for asthma adherence in people with Asthma, run by CoheroHealth at 1 site in United States.
Trial summary
The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Asthma
- What is being tested?
- Inhaler sensor and Mobile application for asthma adherence
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 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 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 11-19
- Asthma diagnosis
- Currently prescribed a hydrofluoroalkane (HFA) asthma controller medication
- English-speaking
- Has a smartphone or access to a smartphone or tablet
Who cannot join
- Pregnant
- Foster Care
- Emancipated minor
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess medication use throughout a 12 week study in patients who receive a mobile app with reminders, asthma control as measured by the ACT [asthma control test], and lung function as measured by spirometry.
- Conditions
- Asthma
- Being tested
- Inhaler sensor, Mobile application for asthma adherence
- Keywords
- Patient Compliance, Mobile Applications
- Medical subject headings
- Asthma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaler sensorDevice
Inhaler sensor strap that tracks inhaler use.
Mobile application for asthma adherenceBehavioural
Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care with Medication Monitoring | Sham comparator | Patients will be given an inhaler sensor to monitor medication use and a sham version of the mobile app that will not include reminders or incentives.
Intervention: inhaler sensor Receives: Device: Inhaler sensor |
| Medication Monitoring and Mobile App | Experimental | Patients will be given an inhaler sensor to monitor medication use and a mobile phone application with reminders to allow self-management of medication use.
Interventions: inhaler sensor and mobile application for asthma adherence Receives: Device: Inhaler sensor; Behavioral: Mobile application for asthma adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time medication adherence in patients using mobile app compared to standard care.
Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm.
Measured: 12 weeks
Secondary outcomes (2)
Asthma control in patients using mobile app compared to standard care
Analysis of the ACT [asthma control test] at baseline and follow up for patients in each arm to assess changes in asthma control with use of the mobile app.
Measured: 12 weeks
Change in lung function with use of a mobile health tool for asthma adherence
Measure change in spirometry by comparing force expiratory volume at one second [FEV1] and forced vital capacity [FVC] at baseline and 12 week visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Lack of funding
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoheroHealth
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Andrew Ting, MD, Principal investigator, Icahn School of Medicine at Mount SinaiMichael Parides, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426814
- Sponsor's protocol ID
- 2015_Spring_Sinai
- Status last verified
- Jul 2023
- First submitted
- 7 Apr 2015
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
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
- Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
- ClinicalTrials.gov ID
- NCT02426814
- Acronym / sponsor ID
- 2015_Spring_Sinai
- Conditions
- Asthma
- Keywords
- Patient Compliance, Mobile Applications
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CoheroHealthIndustry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Aug 2015
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 27 Apr 2015 (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.
The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess medication use throughout a 12 week study in patients who receive a mobile app with reminders, asthma control as measured by the ACT [asthma control test], and lung function as measured by spirometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care with Medication Monitoring | Sham comparator | Device: Inhaler sensorPatients will be given an inhaler sensor to monitor medication use and a sham version of the mobile app that will not include reminders or incentives. Intervention: inhaler sensor |
| Medication Monitoring and Mobile App | Experimental | Device: Inhaler sensor, Behavioral: Mobile application for asthma adherencePatients will be given an inhaler sensor to monitor medication use and a mobile phone application with reminders to allow self-management of medication use. Interventions: inhaler sensor and mobile application for asthma adherence |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 11-19
- Asthma diagnosis
- Currently prescribed a hydrofluoroalkane (HFA) asthma controller medication
- English-speaking
- Has a smartphone or access to a smartphone or tablet
Key exclusion criteria (3 listed)
- Pregnant
- Foster Care
- Emancipated minor
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 |
|---|---|---|
| Inhaler sensorInhaler sensor strap that tracks inhaler use. | Device | Medication Monitoring and Mobile App, Standard Care with Medication Monitoring |
| Mobile application for asthma adherenceMobile phone application that sends reminders and allows patients to self-manage their medication adherence. | Behavioural | Medication Monitoring and Mobile App |
Primary outcome
Real-time medication adherence in patients using mobile app compared to standard care.
Time frame: 12 weeks
Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm.
2 secondary outcomes
Asthma control in patients using mobile app compared to standard care
Time frame: 12 weeks
Change in lung function with use of a mobile health tool for asthma adherence
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
Andrew Ting, MD principal investigator
Icahn School of Medicine at Mount Sinai
Michael Parides, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaler sensor and Mobile application for asthma adherence in people with Asthma, run by CoheroHealth 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 3 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: withdrawn, 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Real-time medication adherence in patients using mobile app compared to standard care. (time frame: 12 weeks). 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 27 Jul 2023.