title: 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©).
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 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ( ACTRN 12613000800729 ) 17 July 2013.
authors.affiliation: Centre for Medicine Use and Safety, Monash University, Parkville, VIC, Australia. Elida.Zairina@monash.edu.
authors.forename: Elida
authors.initials: E
authors.lastname: Zairina
authors.affiliation: Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Michael.Abramson@monash.edu.|Allergy, Immunology & Respiratory Medicine, The Alfred Hospital, Melbourne, VIC, Australia. Michael.Abramson@monash.edu.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Abramson
authors.affiliation: Department of Respiratory and Sleep Medicine, The Austin Hospital, Heidelberg, VIC, Australia. Christine.McDonald@austin.org.au.
authors.forename: Christine F
authors.initials: CF
authors.lastname: McDonald
authors.affiliation: Department of Electrical and Computer Systems Engineering, Faculty of Engineering, Monash University, Clayton, VIC, Australia. Jonathan.Li@monash.edu.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Electrical and Computer Systems Engineering, Faculty of Engineering, Monash University, Clayton, VIC, Australia. Thanuja.Dharmasiri@monash.edu.
authors.forename: Thanuja
authors.initials: T
authors.lastname: Dharmasiri
authors.affiliation: Centre for Medicine Use and Safety, Monash University, Parkville, VIC, Australia. Kay.Stewart@monash.edu.
authors.forename: Kay
authors.initials: K
authors.lastname: Stewart
authors.affiliation: Department of Maternal Fetal Medicine, Mercy Hospital for Women, Melbourne, Australia. spwalker@unimelb.edu.au.|Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia. spwalker@unimelb.edu.au.
authors.forename: Susan P
authors.initials: SP
authors.lastname: Walker
authors.affiliation: Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Eldho.Paul@monash.edu.|Department of Clinical Haematology, The Alfred Hospital, Melbourne, VIC, Australia. Eldho.Paul@monash.edu.
authors.forename: Eldho
authors.initials: E
authors.lastname: Paul
authors.affiliation: Centre for Medicine Use and Safety, Monash University, Parkville, VIC, Australia. Johnson.George@monash.edu.
authors.forename: Johnson
authors.initials: J
authors.lastname: George
mesh_terms: D000328:Adult; D001249:Asthma / Q000503:physiopathology / Q000628:therapy*; D019468:Disease Management; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D063731:Mobile Applications; D008991:Monitoring, Physiologic / Q000379:methods*; D011247:Pregnancy; D011248:Pregnancy Complications; D011446:Prospective Studies; D011788:Quality of Life; D015203:Reproducibility of Results; D012129:Respiratory Function Tests; D016037:Single-Blind Method; D017216:Telemedicine / Q000379:methods*