Developing an Automated Symptom Monitoring Device for Adolescents with Asthma

描述（由申请方提供）：拟定研究的总体目标是开发和评价哮喘监测自动化设备（ADAM）。准确的症状监测是适当的哮喘管理的基石。症状监测告知患者决定启动必要的自我管理行为（例如，调整药物、改变活动水平、改变周围环境或寻求医疗援助）以及提供者关于适当治疗过程的决定。目前的指南强调了持续的症状监测在改善哮喘预后和减少哮喘相关残疾方面的重要性。缺乏客观性和准确性差已经对现有的症状监测方法提出了质疑，包括使用自我报告的症状监测和峰值流量计读数。青春期被认为是症状监测中最具挑战性的时期，主要是由于发育特征混淆了症状感知差和依从性不足。因此，这项研究专门针对青少年。具体目标是：（1）开发一种生物医学设备系统ADAM，该系统可以基于哮喘症状的参数（包括喘息和咳嗽）促进非侵入性、有效和可靠的哮喘症状监测;（2）评价ADAM测量的准确性和有效性;（3）评价研究人群对ADAM的可接受性。本研究包括两个阶段，即开发阶段和验证阶段。在开发阶段，将从患有活动性哮喘症状的青少年（N=24）中采集的呼吸音样本中确定喘息和咳嗽参数。将设计一种专用设备，用于在现实生活环境中进行持续症状监测，应用技术，根据识别的参数和活动水平选择性地捕获喘息和咳嗽。该设备将采用移动的电话作为平台，从麦克风和无线加速度计输入的原始数据被自动处理、分析和存储。参与者将能够查看移动的手机屏幕上显示的数据摘要。测量理论和信号检测理论指导验证阶段的研究设计和分析方法。对于验证阶段，将从哮喘组（n=40）和非哮喘组（n=40）中收集数据。将使用多种统计方法评估ADAM的准确性和有效性，包括受试者工作特征（ROC）曲线和相关分析、多水平建模和生长模型。将来自ADAM的数据与1秒用力呼气容积、呼出的一氧化氮分数以及来自问卷调查的数据进行比较，问卷调查包括哮喘控制测试、哮喘每日日记、症状感知的视觉模拟量表和生活质量。将使用研究设计的问卷和半结构化定性访谈评估器械的用户可接受性。我们预计，这种新设备将是可靠的和临床上有用的，并将提高青少年的坚持症状监测。 公共卫生相关性：哮喘是青少年的主要慢性健康状况。虽然基于准确的症状监测的适当治疗可以预防或大大减少哮喘相关的负面健康后果，但症状监测通常是不充分的或误导性的。这项研究旨在开发和测试一种创新设备，通过应用先进技术，能够捕获呼吸声（如喘息和咳嗽）沿着日常活动水平，从而大大改善青少年的症状监测。

DESCRIPTION (provided by applicant): The overall objective of the proposed study is to develop and evaluate an Automated Device for Asthma Monitoring (ADAM). Accurate symptom monitoring is the cornerstone of appropriate asthma management. 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 regarding an appropriate treatment course. Current guidelines highlight the importance of ongoing symptom monitoring in improving asthma outcomes and reducing asthma-related disability. Lack of objectivity and poor accuracy have called into question existing symptom monitoring approaches including the use of self-reported symptom monitoring and peak flow meter readings. Adolescence has been recognized as the most challenging period in symptom monitoring primarily due to poor symptom perception and inadequate adherence confounded by developmental characteristics. Therefore, this study specifically targets adolescents. Specific aims are: (1) To develop a biomedical device system, ADAM, that can facilitate non-intrusive, valid and reliable monitoring of asthma symptoms based on the parameters of asthma symptoms including wheeze and cough; (2) To evaluate measurement accuracy and validity of ADAM; and (3) To evaluate the acceptability of ADAM by the study population. This study consists of two phases, a Development Phase and a Validation Phase. During the Development Phase, parameters of wheezes and cough will be identified from the breath sound samples collected from adolescents with active asthma symptoms (N=24). A purpose-built device will be designed for continuous symptom monitoring in real-life environments applying technology that enables selective capturing of wheeze and cough based on the identified parameters as well as activity levels. The device will employ a mobile phone as a platform where raw data inputted from a microphone and a wireless accelerometer are automatically processed, analyzed and stored. Participants will be able to review the summary of data displayed on the screen of the mobile phone. Measurement Theory and Signal Detection Theory guide the research design and analytic approaches of the Validation Phase. For the Validation Phase, data will be collected from an asthma group (n=40) and a non-asthma group (n=40). Accuracy and validity of ADAM will be evaluated using multiple statistical methods including Receiver Operating Characteristic (ROC) curve and correlational analyses, multilevel modeling, and the growth model. Data from ADAM will be compared with Forced Expiratory Volume at 1 second, exhaled fractional nitric oxide, and data from questionnaires including the Asthma Control Test, asthma daily diary, visual analogue scale of symptom perception, and quality of life. User acceptability of the device will be assessed using both research-devised questionnaire and semi-structured qualitative interview. We anticipate that this new device will be reliable and clinically useful, and will improve adolescents' adherence to symptom monitoring. PUBLIC HEALTH RELEVANCE: Asthma is the leading chronic health condition in adolescents. While adequate treatments based on accurate symptom monitoring can prevent or substantially reduce asthma-related negative health consequences, symptom monitoring typically is inadequate or misleading. This study aims to develop and test an innovative device to substantially improve symptom monitoring for adolescents through the application of advanced technology that enables capturing of breath sounds such as wheeze and cough along with activity levels on a daily basis.