Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-30 @ 11:33 PM
Study NCT ID:
NCT01696357
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2012-09-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Automated Device for Asthma Monitoring
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Developing an Automated Symptom Monitoring Device for Adolescents With Asthma
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAM
Brief 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. 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: