AsthmaADAMNCT01696357
Automated Device for Asthma Monitoring
An observational study of Asthma, run by University of Rochester at 1 site in United States.
Trial summary
This study will examine an innovative strategy to monitor asthma symptoms by using existing technology to develop a non-invasive device for monitoring asthma symptoms in adolescents. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Automated Device for Asthma Monitoring (ADAM)
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2013
- Phase
- Observational
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents between the ages of 13-17 who received care at Strong Memorial Hospital, Rochester NY.
Who may be able to join
- Age 13 through 17 years,
- Asthma diagnosis from a care provider,
- Prescribed asthma controller medication
- Age 13 through 17 years,
Who cannot join
- Other health conditions (e.g., heart disease, cystic fibrosis) producing asthma-like symptoms,
- Known cognitive, psychological and behavior problems (based on self-report and/or clinician report) that present challenges in following study procedures
- Ability to understand spoken and written English.
- Other health conditions (e.g., heart disease, cystic fibrosis) producing asthma-like symptoms,
- Known cognitive, psychological and behavior problems (based on self-report and/or clinician report) that present challenges in following study procedures
- Ability to understand spoken and written English.
- Asthma diagnosis from a care provider,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing an Automated Symptom Monitoring Device for Adolescents With Asthma
This study will examine an innovative strategy to monitor asthma symptoms by using existing technology to develop a non-invasive device for monitoring asthma symptoms in adolescents. Using an iPod as a platform, and current sound data analysis techniques, a prototype device will be developed that will directly monitor the chosen parameters of asthma symptoms, including wheezing, coughing and activity levels. This small non-invasive device will be continuously carried by or placed in close proximity to the adolescent on a daily basis. It is hypothesized that such a device would be acceptable to adolescents and would lend accuracy and objectivity to symptom assessment; something that existing monitoring strategies have yet to achieve. It will also stimulate the adolescents' partnership in asthma self-monitoring and ultimately lead to effective asthma management.
Read the detailed description
Prior research has generated compelling evidence that programs promoting self-management can reduce morbidity and improve asthma outcomes in children. Successful asthma management strategies require patients' active commitment to engage in care processes by establishing self-monitoring routines. Adequate self-monitoring of asthma symptoms is considered to be the cornerstone of appropriate asthma management leading to fewer cases of asthma exacerbation and acute care visits as well as better functional outcomes and higher quality of life in children and adolescents. Symptom monitoring informs patient decisions to initiate necessary self-management behaviors (e.g., adjust medication, alter activity level, alter the surrounding environment or seek medical assistance) as well as the providers' decisions related to an appropriate treatment course such as step up, no change or step down therapy. Thus, current guidelines by National Heart, Lung, and Blood Institute (NHLBI) Expert Panel Review 3 (EPR3) highlight the importance of ongoing symptom monitoring.
Studies of children have raised concerns about adequacy and effectiveness of current methods of asthma self-monitoring including symptom-based and peak expiratory flow (PEF) monitoring. Symptom-based monitoring relies on the individual's symptom perception which is subjective and influenced by a variety of factors such as the patient's emotional status, social influences (e.g, family, peers) and previous experiences with symptoms. Thus, the accuracy and objectivity of this monitoring method is uncertain. As an objective approach, PEF monitoring has been encouraged, yet the efficacy of this method has also been a subject of ongoing debate in the literature. Poor adherence and inadequate technique further diminish the clinical usefulness of PEF monitoring. Thus, the uncertainty of current monitoring strategies underscores the imperative of an alternative symptom monitoring strategy that addresses the issues of accuracy and objectivity of symptom assessment.
Adolescence is an important period for consolidating and establishing self-management of and adjustment to chronic health conditions. Yet an array of developmental challenges including the desire for normalcy and peer approval, feelings of invulnerability and emerging independence undermine adolescents' motivation and behaviors to engage in self-management and present particular difficulties in achieving optimal asthma control in adolescents with asthma. Parents become less able to manage asthma as children reach adolescence and many researchers and clinicians have reported similar difficulties in managing asthma in adolescents primarily due to inadequate adherence and counterproductive behaviors. Thus, clinicians face serious challenges in providing optimal management for adolescents with asthma primarily due to difficulties in soliciting patients' active partnership in asthma management with sustainable and reliable symptom monitoring routines. Accurate symptom monitoring by patients is the most fundamental antecedent to effective asthma management, yet existing monitoring strategies have not been conducive to adolescents' cooperation or yielded accurate or clinically useful information. Having recognized these limitations, this study will examine an innovative strategy to monitor asthma symptoms that stimulates adolescents' partnership and ultimately leads to effective asthma management.
The device will directly monitor the chosen parameters of asthma symptoms, including wheezing, coughing and activity levels. A mobile phone will be employed as a platform for processing, analyzing and storing data transmitted from a microphone and a wireless accelerometer. This new approach is developmentally appropriate, given adolescents' affinity for technology and its capacity to address adolescents' need for maintaining normalcy while allowing continuous asthma monitoring during real-life situations. The device involves biomedical engineering techniques enabling automatic sound and activity recording, analysis, feedback, and storage function. A mobile phone will be employed as a platform for processing, analyzing and storing data transmitted from a microphone and a wireless accelerometer. This technology will automate daily symptom monitoring with minimal intrusiveness and maximum accuracy, thereby reducing the risk of inappropriate treatment and ameliorating asthma-related disability. Due to its foreseen safety, noninvasiveness, objectivity, convenience, user-friendliness, and cost containment, the approach can greatly enhance asthma management by adolescents and health care providers. This device has the potential to bring about patient behavior changes such as avoiding triggers and adjusting medications as the device will provide the opportunity for in-time review of symptoms.
- Conditions
- Asthma
- Being tested
- Automated Device for Asthma Monitoring (ADAM)
- Keywords
- Asthma, Adolescents, Self-monitoring, Quality of life, Biomedical device, Symptom monitoring, Self-management
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Device for Asthma Monitoring (ADAM)Device
Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with asthma | Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication. Receives: Device: Automated Device for Asthma Monitoring (ADAM) | |
| Adolescents without asthma | Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms. Receives: Device: Automated Device for Asthma Monitoring (ADAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Coughs Per Hour
The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startSep 2009
- Primary completionAug 2013
- Study completionAug 2013
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 (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyekyun Rhee, University of Rochester
- Investigators
- Hyekyun Rhee, PhD, RN, PNP, Principal investigator, University of Rochester School of NursingMark Bocko, PhD, Principal investigator, University of Rochester Electrical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696357
- Sponsor's protocol ID
- 5R01NR011169
- Acronym
- ADAM
- Status last verified
- Dec 2014
- First submitted
- 18 Sep 2012
- Last updated
- 10 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rhee H, Miner S, Sterling M, Halterman JS, Fairbanks E. The development of an automated device for asthma monitoring for adolescents: methodologic approach and user acceptability. JMIR Mhealth Uhealth. 2014 Jun 19;2(2):e27. doi: 10.2196/mhealth.3118.
PubMed 25100184Rhee H, Fairbanks E, Butz A. Symptoms, feelings, activities and medication use in adolescents with uncontrolled asthma: lessons learned from asthma diaries. J Pediatr Nurs. 2014 Jan-Feb;29(1):39-46. doi: 10.1016/j.pedn.2013.04.009. Epub 2013 May 15.
PubMed 23685266Sterling M, Rhee H, Bocko M. Automated Cough Assessment on a Mobile Platform. J Med Eng. 2014;2014:951621. doi: 10.1155/2014/951621.
PubMed 25506590Rhee H, Belyea M, Mammen J. Visual analogue scale (VAS) as a monitoring tool for daily changes in asthma symptoms in adolescents: a prospective study. Allergy Asthma Clin Immunol. 2017 Apr 28;13:24. doi: 10.1186/s13223-017-0196-7. eCollection 2017.
PubMed 28465694
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Automated Symptom Monitoring Device for Adolescents With Asthma
- ClinicalTrials.gov ID
- NCT01696357
- Acronym / sponsor ID
- ADAM / 5R01NR011169
- Conditions
- Asthma
- Keywords
- Asthma, Adolescents, Self-monitoring, Quality of life, Biomedical device, Symptom monitoring, Self-management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Posted 10 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine an innovative strategy to monitor asthma symptoms by using existing technology to develop a non-invasive device for monitoring asthma symptoms in adolescents. Using an iPod as a platform, and current sound data analysis techniques, a prototype device will be developed that will directly monitor the chosen parameters of asthma symptoms, including wheezing, coughing and activity levels. This small non-invasive device will be continuously carried by or placed in close proximity to the adolescent on a daily basis. It is hypothesized that such a device would be acceptable to adolescents and would lend accuracy and objectivity to symptom assessment; something that existing monitoring strategies have yet to achieve. It will also stimulate the adolescents' partnership in asthma self-monitoring and ultimately lead to effective asthma management.
Detailed description
Prior research has generated compelling evidence that programs promoting self-management can reduce morbidity and improve asthma outcomes in children. Successful asthma management strategies require patients' active commitment to engage in care processes by establishing self-monitoring routines. Adequate self-monitoring of asthma symptoms is considered to be the cornerstone of appropriate asthma management leading to fewer cases of asthma exacerbation and acute care visits as well as better functional outcomes and higher quality of life in children and adolescents. Symptom monitoring informs patient decisions to initiate necessary self-management behaviors (e.g., adjust medication, alter activity level, alter the surrounding environment or seek medical assistance) as well as the providers' decisions related to an appropriate treatment course such as step up, no change or step down therapy. Thus, current guidelines by National Heart, Lung, and Blood Institute (NHLBI) Expert Panel Review 3 (EPR3) highlight the importance of ongoing symptom monitoring.
Studies of children have raised concerns about adequacy and effectiveness of current methods of asthma self-monitoring including symptom-based and peak expiratory flow (PEF) monitoring. Symptom-based monitoring relies on the individual's symptom perception which is subjective and influenced by a variety of factors such as the patient's emotional status, social influences (e.g, family, peers) and previous experiences with symptoms. Thus, the accuracy and objectivity of this monitoring method is uncertain. As an objective approach, PEF monitoring has been encouraged, yet the efficacy of this method has also been a subject of ongoing debate in the literature. Poor adherence and inadequate technique further diminish the clinical usefulness of PEF monitoring. Thus, the uncertainty of current monitoring strategies underscores the imperative of an alternative symptom monitoring strategy that addresses the issues of accuracy and objectivity of symptom assessment.
Adolescence is an important period for consolidating and establishing self-management of and adjustment to chronic health conditions. Yet an array of developmental challenges including the desire for normalcy and peer approval, feelings of invulnerability and emerging independence undermine adolescents' motivation and behaviors to engage in self-management and present particular difficulties in achieving optimal asthma control in adolescents with asthma. Parents become less able to manage asthma as children reach adolescence and many researchers and clinicians have reported similar difficulties in managing asthma in adolescents primarily due to inadequate adherence and counterproductive behaviors. Thus, clinicians face serious challenges in providing optimal management for adolescents with asthma primarily due to difficulties in soliciting patients' active partnership in asthma management with sustainable and reliable symptom monitoring routines. Accurate symptom monitoring by patients is the most fundamental antecedent to effective asthma management, yet existing monitoring strategies have not been conducive to adolescents' cooperation or yielded accurate or clinically useful information. Having recognized these limitations, this study will examine an innovative strategy to monitor asthma symptoms that stimulates adolescents' partnership and ultimately leads to effective asthma management.
The device will directly monitor the chosen parameters of asthma symptoms, including wheezing, coughing and activity levels. A mobile phone will be employed as a platform for processing, analyzing and storing data transmitted from a microphone and a wireless accelerometer. This new approach is developmentally appropriate, given adolescents' affinity for technology and its capacity to address adolescents' need for maintaining normalcy while allowing continuous asthma monitoring during real-life situations. The device involves biomedical engineering techniques enabling automatic sound and activity recording, analysis, feedback, and storage function. A mobile phone will be employed as a platform for processing, analyzing and storing data transmitted from a microphone and a wireless accelerometer. This technology will automate daily symptom monitoring with minimal intrusiveness and maximum accuracy, thereby reducing the risk of inappropriate treatment and ameliorating asthma-related disability. Due to its foreseen safety, noninvasiveness, objectivity, convenience, user-friendliness, and cost containment, the approach can greatly enhance asthma management by adolescents and health care providers. This device has the potential to bring about patient behavior changes such as avoiding triggers and adjusting medications as the device will provide the opportunity for in-time review of symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with asthma | – | Device: Automated Device for Asthma Monitoring (ADAM)Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication. |
| Adolescents without asthma | – | Device: Automated Device for Asthma Monitoring (ADAM)Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents between the ages of 13-17 who received care at Strong Memorial Hospital, Rochester NY.
Key inclusion criteria (4 listed)
- Age 13 through 17 years,
- Asthma diagnosis from a care provider,
- Prescribed asthma controller medication
- Age 13 through 17 years,
Key exclusion criteria (7 listed)
- Other health conditions (e.g., heart disease, cystic fibrosis) producing asthma-like symptoms,
- Known cognitive, psychological and behavior problems (based on self-report and/or clinician report) that present challenges in following study procedures
- Ability to understand spoken and written English.
- Other health conditions (e.g., heart disease, cystic fibrosis) producing asthma-like symptoms,
- Known cognitive, psychological and behavior problems (based on self-report and/or clinician report) that present challenges in following study procedures
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 |
|---|---|---|
| Automated Device for Asthma Monitoring (ADAM)Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device. | Device | Adolescents with asthma, Adolescents without asthma |
Primary outcome
Average Number of Coughs Per Hour
Time frame: 7 days
The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25100184Rhee H, Miner S, Sterling M, Halterman JS, Fairbanks E. The development of an automated device for asthma monitoring for adolescents: methodologic approach and user acceptability. JMIR Mhealth Uhealth. 2014 Jun 19;2(2):e27. doi: 10.2196/mhealth.3118.
- Results publication: PubMed 23685266Rhee H, Fairbanks E, Butz A. Symptoms, feelings, activities and medication use in adolescents with uncontrolled asthma: lessons learned from asthma diaries. J Pediatr Nurs. 2014 Jan-Feb;29(1):39-46. doi: 10.1016/j.pedn.2013.04.009. Epub 2013 May 15.
- Results publication: PubMed 25506590Sterling M, Rhee H, Bocko M. Automated Cough Assessment on a Mobile Platform. J Med Eng. 2014;2014:951621. doi: 10.1155/2014/951621.
- Derived from this study: PubMed 28465694Rhee H, Belyea M, Mammen J. Visual analogue scale (VAS) as a monitoring tool for daily changes in asthma symptoms in adolescents: a prospective study. Allergy Asthma Clin Immunol. 2017 Apr 28;13:24. doi: 10.1186/s13223-017-0196-7. eCollection 2017.
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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.
Hyekyun Rhee, PhD, RN, PNP principal investigator
University of Rochester School of Nursing
Mark Bocko, PhD principal investigator
University of Rochester Electrical Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of Rochester 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 7 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 10 Dec 2014. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2014). 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?
Average Number of Coughs Per Hour (time frame: 7 days). 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 NCT01696357, which also lists 4 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 10 Dec 2014.