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AsthmaADAMNCT01696357

Automated Device for Asthma Monitoring

An observational study of Asthma, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

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 groups in NCT01696357
Study groupRoleWhat they receive
Adolescents with asthmaAges 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 asthmaAges 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.

  1. 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.

  1. First posted1 Oct 2012 (estimated)
  2. Study startSep 2009
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

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)
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
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 25100184
  • Rhee 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 23685266
  • Sterling M, Rhee H, Bocko M. Automated Cough Assessment on a Mobile Platform. J Med Eng. 2014;2014:951621. doi: 10.1155/2014/951621.

    PubMed 25506590
  • Rhee 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

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.

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