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©)

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 asthma control 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. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ( ACTRN 12613000800729 ) 17 July 2013.