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©).

Elida Zairina,Jonathan Li,Kay Stewart,Eldho Paul,Michael J Abramson,Susan P Walker,Thanuja Dharmasiri,Christine F Mcdonald,Johnson George

doi:10.1186/s12890-015-0082-3

Abstract

BackgroundTelehealth 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.MethodsA 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry (ACTRN 12613000800729) 17 July 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-015-0082-3) contains supplementary material, which is available to authorized users.

Highlights

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
Asthma management programs for pregnant women which involve regular monitoring of lung function and assessment of asthma symptoms appear to be effective in reducing asthma exacerbations [11, 12]
The study aims to evaluate the efficacy of a telehealth intervention supported by a handheld respiratory device and a written asthma action plan (WAAP) for management of asthma in improving asthma control during pregnancy

Summary

Discussion

Innovative solutions are needed to support selfmanagement and to improve asthma control during pregnancy. The Breathe-easy© application has been developed to record lung function data, asthma symptoms and medication usage and provides a user-friendly interface through a smart mobile phone. The WAAP alone may be effective in achieving asthma control, the telehealth (Breathe-easy©) app had additional features for monitoring and recording symptoms and lung function to give instant feedback to participants about their asthma status using an algorithm based on an individualized WAAP. The proposed intervention has the potential to identify worsening asthma control early and prevent asthma exacerbations during pregnancy by regularly monitoring lung function and asthma symptoms. This may translated to reduce health care costs through fewer asthmarelated unplanned medical and emergency department visits.

Background

Methods