评估远程医疗项目效力的一项随机对照试验研究方案：运用对呼吸功能的远程支持性医疗管理孕期哮喘(MASTERY(©))
2015/10/23
摘要
背景：远程医疗通过卫生专业人员定期监测肺功能和/或哮喘症状并反馈患者，有希望改善哮喘管理。虽然远程医疗用以改善哮喘管理的益处已被广泛研究，然而其用以支持妊娠妇女哮喘管理的可行性尚不可知。本研究旨在评估远程医疗在孕期远距离监测肺功能和优化哮喘管理中的使用。
方法：随机对照试验比较常规医疗和远程医疗(MASTERY(©)) 。干预组：使用支持蓝牙功能的手持设备（copd-6®）中的“轻松呼吸 (©)”APP，进行每天两次肺功能 (FEV1, FEV6)自我监测，每周记录哮喘症状和药物使用情况及制定一份书面哮喘行动计划（WAAP）。运用哮喘控制问卷（ACQ）评定哮喘控制的变化，并以此作为主要评估结果。次要结果包括：微型哮喘生活质量问卷（mAQLQ）评分、肺功能、哮喘相关就诊、请假天数及口服糖皮质激素的使用。由不知分组分配的研究助手分别于试验起始、3月及6月收集结果数据。于产后收集母亲及新生儿数据。
讨论：这是第一项评估远程医疗应用于改善孕妇哮喘管理的研究。如果证实有效，该远程医疗项目可能通过改善孕妇的哮喘自我管理，降低妊娠期哮喘控制不佳对母体及胎儿的风险。
（苏欣 审校）
BMC Pulm Med. 2015 Jul 31;15:84. doi: 10.1186/s12890-015-0082-3.
Study protocol for a randomised controlled trial evaluating the efficacy of a telehealth program - management of asthma with supportive telehealth of respiratory function in pregnancy (MASTERY(©)).
Zairina E1, Abramson MJ2,3, McDonald CF4, Li J5, Dharmasiri T6, Stewart K7, Walker SP8,9, Paul E10,11, George J12.
Abstract
BACKGROUND:Telehealth has the potential to improve asthma management through regular monitoring of lung function and/or asthma symptoms by health professionals in conjunction with feedback to patients. Although the benefits of telehealth for improving asthma management have been extensively studied, the feasibility of telehealth for supporting asthma management in pregnant women has not been investigated. This study aims to evaluate the use of telehealth for remotely monitoring lung function and optimising asthmacontrol during pregnancy.
METHODS:A randomised controlled trial comparing usual care with a telehealth program (MASTERY(©)) has been conducted. The intervention comprised a mobile application - Breathe-easy (©) supported by a Bluetooth-enabled handheld device (COPD-6®), which was used for self-monitoring of lung function (FEV1, FEV6) twice daily, and recording asthma symptoms and medication usage weekly; and a written asthma action plan (WAAP). The primary outcome measure is change in asthma control measured using the Asthma Control Questionnaire (ACQ). Secondary outcomes include changes in mini-Asthma Quality of Life Questionnaire (mAQLQ) score, lung function, asthma-related health visits, days off work/study, and oral corticosteroid use. Outcome data were collected at baseline, 3 months and 6 months by a research assistant masked to group allocation. Maternal and neonatal outcomes were also collected post-partum.
DISCUSSION:This is the first study to evaluate the application of telehealth to optimize asthma management in pregnant women. If effective, this telehealth program could improve asthma self-management by pregnant women which may reduce the maternal and fetal risks of poorly controlled asthma during pregnancy.
BMC Pulm Med. 2015 Jul 31;15:84. doi: 10.1186/s12890-015-0082-3.
