Developing an Automated Symptom Monitoring Device for Adolescents with Asthma

描述（由申请人提供）：拟议研究的总体目标是开发和评估哮喘监测自动化装置（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。目前的指南强调持续症状监测在改善哮喘结局和减少哮喘相关残疾方面的重要性。由于缺乏客观性和准确性，现有的症状监测方法受到了质疑，包括使用自我报告的症状监测和峰值流量仪表读数。青少年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导致的症状感知不良和依从性不足。因此，本研究专门针对青少年。具体目标是：(1)开发基于气喘、咳嗽等哮喘症状参数的生物医学设备系统ADAM，实现对哮喘症状的非侵入性、有效、可靠的监测；(2)评价ADAM的测量精度和有效性；(3)评估研究人群对ADAM的接受程度。本研究分为两个阶段：开发阶段和验证阶段。在发育阶段，将从有活动性哮喘症状的青少年（N=24）收集的呼吸声样本中识别喘息和咳嗽参数。将设计一种专用设备，用于在现实生活环境中持续监测症状，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。该设备将使用手机作为平台，从麦克风和无线加速度计输入的原始数据将被自动处理、分析和存储。参与者将能够查看显示在手机屏幕上的数据摘要。测量理论和信号检测理论指导了验证阶段的研究设计和分析方法。在验证阶段，将从哮喘组（n=40）和非哮喘组（n=40）收集数据。将使用多种统计方法，包括受试者工作特征（ROC）曲线和相关分析、多水平建模和增长模型来评估ADAM的准确性和有效性。ADAM数据将与1秒用力呼气量、呼出一氧化氮分数、哮喘控制测试、哮喘日记、症状感知视觉模拟量表和生活质量等问卷数据进行比较。用户对设备的接受程度将通过研究设计的问卷和半结构化的定性访谈来评估。我们预期这种新设备将是可靠的和临床上有用的，并将提高青少年对症状监测的依从性。

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.