AsthmaNCT02426801
Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma
A study testing Inhaler sensor and Mobile application for asthma adherence in people with Asthma, run by CoheroHealth.
Trial summary
The purpose of this study is to assess the feasibility of using a mobile health intervention to improve adherence to asthma medication among adolescents in an urban clinic setting. 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
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2014
- 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 on a daily controller medication for Asthma
- English-speaking
Who cannot join
- Pregnant
- Foster Care
- Emancipated minor
About this study
Official title: Feasibility of a Mobile Intervention to Increase Adherence to Asthma Medication Among Children Age 11 to 19 in an Urban Setting
The purpose of this study is to assess the feasibility of using a mobile health intervention to improve adherence to asthma medication among adolescents in an urban clinic setting. 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 the feasibility and acceptability of this intervention to patients.
- Conditions
- Asthma
- Being tested
- Inhaler sensor, Mobile application for asthma adherence
- Keywords
- Patient Compliance, Mobile Applications, Medication Adherence
- Medical subject headings
- Asthma, Patient Compliance, Medication Adherence
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 via a pressure sensitive switch.
Mobile application for asthma adherenceBehavioural
Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this arm were given no intervention. Their self-reported medication adherence was assessed at the baseline (week 0) and follow-up (week 12) visits but during the study period they did not receive any intervention. |
| Medication Sensor Only | Sham comparator | These patients received the medication use sensor (sham intervention) and downloaded a sham version of the mobile app. Thus, the medication use from these patients was able to be recorded but the patients did not receive reminders or incentives or the ability to see their medication use via the real mobile app.
Intervention: inhaler sensor Receives: Device: Inhaler sensor |
| Medication Sensor and Mobile App | Experimental | These patients received the medication use sensor and the mobile app with reminders (intervention arm).
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.
Evidence of ability to monitor medication use at home via a sensor strap
Ability to measure medication use via the sensor strap and upload that information to the HIPAA (Health Insurance Portability and Accountability Act) compliant server.
Measured: 12 weeks
Secondary outcomes (2)
Patient feedback for improved design of a mobile adherence tool
Feedback from patients on the design of the inhaler sensor and mobile app including aesthetics and ease of use.
Measured: 12 weeks
Acceptability of mobile adherence strategy for adolescents with asthma (Based on questions as part of baseline/followup visits and focus group.)
Based on questions as part of baseline/followup visits and focus group.
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 startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- Michael M Parides, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiAndrew M Ting, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426801
- Sponsor's protocol ID
- 2014_Spring_Feasibility
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2015
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stern L, Berman J, Lumry W, Katz L, Wang L, Rosenblatt L, Doyle JJ. Medication compliance and disease exacerbation in patients with asthma: a retrospective study of managed care data. Ann Allergy Asthma Immunol. 2006 Sep;97(3):402-8. doi: 10.1016/S1081-1206(10)60808-3.
PubMed 17042149Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001 Aug;23(8):1296-310. doi: 10.1016/s0149-2918(01)80109-0.
PubMed 11558866Chapman KR, Walker L, Cluley S, Fabbri L. Improving patient compliance with asthma therapy. Respir Med. 2000 Jan;94(1):2-9. doi: 10.1053/rmed.1999.0667.
PubMed 10714473Einarson TR. Drug-related hospital admissions. Ann Pharmacother. 1993 Jul-Aug;27(7-8):832-40. doi: 10.1177/106002809302700702.
PubMed 8364259Bender BG, Rand C. Medication non-adherence and asthma treatment cost. Curr Opin Allergy Clin Immunol. 2004 Jun;4(3):191-5. doi: 10.1097/00130832-200406000-00009.
PubMed 15126940Lasmar L, Camargos P, Champs NS, Fonseca MT, Fontes MJ, Ibiapina C, Alvim C, Moura JA. Adherence rate to inhaled corticosteroids and their impact on asthma control. Allergy. 2009 May;64(5):784-9. doi: 10.1111/j.1398-9995.2008.01877.x. Epub 2009 Jan 21.
PubMed 19183166Patrick H, Williams GC. Self-determination theory: its application to health behavior and complementarity with motivational interviewing. Int J Behav Nutr Phys Act. 2012 Mar 2;9:18. doi: 10.1186/1479-5868-9-18.
PubMed 22385676McCallum S. Gamification and serious games for personalized health. Stud Health Technol Inform. 2012;177:85-96.
PubMed 22942036Csikszentmihalyi M, Rathunde K. The measurement of flow in everyday life: toward a theory of emergent motivation. Nebr Symp Motiv. 1992;40:57-97. No abstract available.
PubMed 1340523
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Mobile Intervention to Increase Adherence to Asthma Medication Among Children Age 11 to 19 in an Urban Setting
- ClinicalTrials.gov ID
- NCT02426801
- Acronym / sponsor ID
- 2014_Spring_Feasibility
- Conditions
- Asthma
- Keywords
- Patient Compliance, Mobile Applications, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CoheroHealthIndustry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- 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 feasibility of using a mobile health intervention to improve adherence to asthma medication among adolescents in an urban clinic setting. 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 the feasibility and acceptability of this intervention to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this arm were given no intervention. Their self-reported medication adherence was assessed at the baseline (week 0) and follow-up (week 12) visits but during the study period they did not receive any intervention. |
| Medication Sensor Only | Sham comparator | Device: Inhaler sensorThese patients received the medication use sensor (sham intervention) and downloaded a sham version of the mobile app. Thus, the medication use from these patients was able to be recorded but the patients did not receive reminders or incentives or the ability to see their medication use via the real mobile app. Intervention: inhaler sensor |
| Medication Sensor and Mobile App | Experimental | Device: Inhaler sensor, Behavioral: Mobile application for asthma adherenceThese patients received the medication use sensor and the mobile app with reminders (intervention arm). 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 (4 listed)
- Age 11-19
- Asthma diagnosis
- Currently on a daily controller medication for Asthma
- English-speaking
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 via a pressure sensitive switch. | Device | Medication Sensor Only, Medication Sensor and Mobile App |
| Mobile application for asthma adherenceMobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use. | Behavioural | Medication Sensor and Mobile App |
Primary outcome
Evidence of ability to monitor medication use at home via a sensor strap
Time frame: 12 weeks
Ability to measure medication use via the sensor strap and upload that information to the HIPAA (Health Insurance Portability and Accountability Act) compliant server.
2 secondary outcomes
Patient feedback for improved design of a mobile adherence tool
Time frame: 12 weeks
Acceptability of mobile adherence strategy for adolescents with asthma (Based on questions as part of baseline/followup visits and focus group.)
Time frame: 12 weeks
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 Apr 2015.
- Background: PubMed 17042149Stern L, Berman J, Lumry W, Katz L, Wang L, Rosenblatt L, Doyle JJ. Medication compliance and disease exacerbation in patients with asthma: a retrospective study of managed care data. Ann Allergy Asthma Immunol. 2006 Sep;97(3):402-8. doi: 10.1016/S1081-1206(10)60808-3.
- Background: PubMed 11558866Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001 Aug;23(8):1296-310. doi: 10.1016/s0149-2918(01)80109-0.
- Background: PubMed 10714473Chapman KR, Walker L, Cluley S, Fabbri L. Improving patient compliance with asthma therapy. Respir Med. 2000 Jan;94(1):2-9. doi: 10.1053/rmed.1999.0667.
- Background: PubMed 8364259Einarson TR. Drug-related hospital admissions. Ann Pharmacother. 1993 Jul-Aug;27(7-8):832-40. doi: 10.1177/106002809302700702.
- Background: PubMed 15126940Bender BG, Rand C. Medication non-adherence and asthma treatment cost. Curr Opin Allergy Clin Immunol. 2004 Jun;4(3):191-5. doi: 10.1097/00130832-200406000-00009.
- Background: PubMed 19183166Lasmar L, Camargos P, Champs NS, Fonseca MT, Fontes MJ, Ibiapina C, Alvim C, Moura JA. Adherence rate to inhaled corticosteroids and their impact on asthma control. Allergy. 2009 May;64(5):784-9. doi: 10.1111/j.1398-9995.2008.01877.x. Epub 2009 Jan 21.
- Background: PubMed 22385676Patrick H, Williams GC. Self-determination theory: its application to health behavior and complementarity with motivational interviewing. Int J Behav Nutr Phys Act. 2012 Mar 2;9:18. doi: 10.1186/1479-5868-9-18.
- Background: PubMed 22942036McCallum S. Gamification and serious games for personalized health. Stud Health Technol Inform. 2012;177:85-96.
- Background: PubMed 1340523Csikszentmihalyi M, Rathunde K. The measurement of flow in everyday life: toward a theory of emergent motivation. Nebr Symp Motiv. 1992;40:57-97. No abstract available.
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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.
Michael M Parides, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Andrew M Ting, MD principal investigator
Icahn School of Medicine at Mount Sinai
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.
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 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: finished, as of the sponsor's last update on 27 Apr 2015. 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. 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 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?
Evidence of ability to monitor medication use at home via a sensor strap (time frame: 12 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 NCT02426801, which also lists 9 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 27 Apr 2015.