Location and timing of inhaler use, exacerbations and physical activity in COPD

描述(由申请人提供)： 慢性阻塞性肺疾病(COPD)影响多达20%的VA患者，并与与健康相关的生活质量差、频繁加重和残疾相关。建议COPD患者进行体力活动(PA)，但体力活动可能会受到空气污染和温度变化等环境因素引发的加重和恶化的呼吸道症状的影响。短效β-激动剂支气管扩张剂使用量的增加可能反映了急性环境暴露、轻度恶化或中度或重度恶化开始时的短暂恶化症状。最近开发的一种启用全球定位系统(GPS)的吸入器可以监测支气管扩张剂的使用位置和时间。使用GPS功能的吸入器测量增加的β-激动剂使用量是测量轻度恶化的一种新方法，将允许更好地了解导致COPD恶化和干扰PA的环境因素。这项研究的具体目标是：目标1：利用全球定位系统(GPS)启用的短效β-激动剂(SABA)吸入器设备捕捉不断恶化的呼吸道症状和轻度恶化。目的2：使用计步器和体力活动检查表来描述COPD患者的PA。目的3：检查环境诱因(空气污染、温度、相对湿度)是否与启用GPS的SABA吸入器测量的轻度恶化有关。这项拟议的研究将对40名患有中到重度COPD的退伍军人进行纵向观察研究。来自VA Puget Sound Health Care System的被诊断为COPD的参与者将被要求参加，如果他们的肺活量FEV1/FVC在0.3到0.7之间，并且正在使用由计量吸入器(MDI)提供的短效支气管扩张剂(例如沙丁胺醇)。启用GPS的监测设备将被放置在患者的MDI罐的顶部，以记录使用MDI的时间和位置。参与者将被跟踪总共12周。这项研究确定的数据将包括吸入器使用的日常测量(时间、地点)、每日运动(GPS每30分钟监测一次)和每日计步器的步数测量。患者将每月进行研究访问，下载GPS和计步器数据，并填写关于恶化史、PA的最后7天和慢性呼吸道症状的问卷。此外，患者将被要求填写一份为期7天的活动日记，以收集有关他们日常生活的更详细信息。关于患者全天位置和MDI启动地点的GPS数据将与环境保护局(EPA)的西雅图空气污染数据和美国国家海洋和大气管理局(NOAA)的气象学数据相关联。数据分析将侧重于每项测量的描述性统计，表征短效β-受体激动剂使用量的增加，并衡量患者对GPS启用的MDI、计步器和活动日记的依从性。这项研究的结果将被用来为一项优点审查建议提供参考，该建议旨在评估对COPD患者进行PA干预时病情恶化的影响，以及环境因素对这些恶化的影响。这项未来研究的具体目标将是：1)确定与减少参与体力活动、锻炼计划和肺康复有关的因素(包括使用启用GPS的MDI测量的轻度恶化)，以及2)开发一种干预措施，以增加COPD患者的体力活动，其中包括预防恶化的策略，包括避免环境触发因素，以及在经历恶化后保持体力活动。通过更好地了解轻度恶化对PA的影响，以及轻微恶化的潜在环境触发因素，我们可以为患者和他们的提供者提供更适当的建议，指导他们如何减少恶化，并在家中发展和维持PA。

DESCRIPTION (provided by applicant): Chronic Obstructive Pulmonary Disease (COPD) affects up to 20% of VA patients and is associated with poor health-related quality of life, frequent exacerbations, and disability. Physical activity (PA) is recommended for COPD patients, however PA may be affected by exacerbations and worsening respiratory symptoms triggered by environmental factors such as air pollution and changes in temperature. Increased use of short acting beta- agonist bronchodilator use may reflect transient worsening symptoms in the setting of an acute environmental exposure, a mild exacerbation, or the beginning of a moderate or severe exacerbation. A recently developed global positioning system (GPS)-enabled inhaler permits monitoring of both location and timing of bronchodilator use. Measuring increased beta-agonist use with the GPS-enabled inhaler is a novel method to measure mild exacerbations and will allow a better understanding of environmental factors that worsen COPD and interfere with PA. The study specific aims are: Aim 1: To capture worsening respiratory symptoms and mild exacerbations with a global positioning system (GPS)-enabled short-acting beta-agonist (SABA) inhaler device. Aim 2: To characterize PA in patients with COPD using pedometers and a Physical Activity Checklist. Aim 3: To examine whether environmental triggers (air pollution, temperature, relative humidity) are linked to mild exacerbations as measured by GPS-enabled SABA inhaler device. The proposed study will be a longitudinal observational study of 40 Veterans with moderate to severe COPD. Participants diagnosed with COPD from the VA Puget Sound Health Care System will be asked to participate if they have an FEV1/FVC between 0.3 and 0.7 on spirometry and are using a short-acting bronchodilator (e.g., albuterol) delivered by metered-dose inhaler (MDI). The GPS-enabled monitoring device will be placed on top of the patient's MDI canister to record the time and location of MDI use. Participants will be followed for a total of 12 weeks. Data ascertained from the study will include daily measurements of inhaler use (time, location), daily movements (GPS monitoring every 30 minutes), and daily pedometer measurements of steps taken. Patients will have monthly study visits to download GPS and pedometer data and to fill out questionnaires about history of exacerbations, the last 7 days of PA, and chronic respiratory symptoms. Additionally, patients will be asked to fill out a 7-day activity diary to collect more detailed information about their daily routines. GPS data on patient location throughout the day and place where the MDI was actuated will be linked to data on Seattle air pollution from the Environmental Protection Agency (EPA) and meteorology data from the National Oceanic and Atmospheric Administration (NOAA). Data analysis will focus on descriptive statistics for each measure, characterizing increased short-acting beta agonist use, and measuring patient compliance with the GPS-enabled MDI, pedometer, and activity diary. The results of this study will be used to inform a Merit Review proposal to evaluate the impact of exacerbations on a PA intervention for COPD patients and the contribution of environmental triggers to these exacerbations. Specifically the goals of the future study would be to: 1) determine the factors (including mild exacerbations measured using GPS-enabled MDI use) associated with decreased participation in physical activity, exercise programs, and pulmonary rehabilitation, and 2) to develop an intervention to increase physical activity in COPD that incorporates strategies to prevent exacerbations including avoiding environmental triggers, and maintaining physical activity after experiencing exacerbations. By better understanding the effect of mild exacerbations on PA, as well as the potential environmental triggers of mild exacerbations, we can provide patients and their providers with more appropriate advice about how to reduce exacerbations and develop and sustain PA at home.