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 ©)

BMC Pulmonary Medicine

Johnson George⁶  Eldho Paul⁵  Susan P. Walker³  Kay Stewart⁶  Thanuja Dharmasiri⁴  Jonathan Li⁴  Christine F. McDonald²  Michael J. Abramson¹  Elida Zairina⁶ 

[1] Allergy, Immunology & Respiratory Medicine, The Alfred Hospital, Melbourne, VIC, Australia;Department of Respiratory and Sleep Medicine, The Austin Hospital, Heidelberg, VIC, Australia;Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia;Department of Electrical and Computer Systems Engineering, Faculty of Engineering, Monash University, Clayton, VIC, Australia;Department of Clinical Haematology, The Alfred Hospital, Melbourne, VIC, Australia;Centre for Medicine Use and Safety, Monash University, Parkville, VIC, Australia

关键词: Telehealth;    Pregnancy;    Asthma;   

Others  :  1222563
DOI  :  10.1186/s12890-015-0082-3

 received in 2015-01-13, accepted in 2015-07-23,  发布年份 2015

【 摘 要 】

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 (FEV ₁ , FEV ₆ ) 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

【 授权许可】

   
2015 Zairina et al.

【 图 表 】

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【 参考文献 】

• [1]Kwon HL, Belanger K, Bracken MB. Asthma prevalence among pregnant and childbearing-aged women in the United States: estimates from national health surveys. Ann Epidemiol. 2003; 13:317-324.
• [2]Kwon HL, Triche EW, Belanger K, Bracken MB. The epidemiology of asthma during pregnancy: prevalence, diagnosis, and symptoms. Immunol Allergy Clin N Am. 2006; 26:29-62.
• [3]Clifton VL, Engel P, Smith R, Gibson P, Brinsmead M, Giles WB. Maternal and neonatal outcomes of pregnancies complicated by asthma in an Australian population. Aust N Z J Obstet Gynaecol. 2009; 49:619-626.
• [4]Sawicki E, Stewart K, Wong S, Paul E, Leung L, George J. Management of asthma by pregnant women attending an Australian maternity hospital. Aust N Z J Obstet Gynaecol. 2011;1–6.
• [5]Schatz M, Harden K, Forsythe A, Chilingar L, Hoffman C, Sperling W, Zeiger RS. The course of asthma during pregnancy, post partum, and with successive pregnancies: a prospective analysis. J Allergy Clin Immunol. 1988; 81:509-517.
• [6]Murphy VE, Wang G, Namazy JA, Powell H, Gibson PG, Chambers C, Schatz M. The risk of congenital malformations, perinatal mortality and neonatal hospitalisation among pregnant women with asthma: a systematic review and meta-analysis. BJOG. 2013; 120:812-822.
• [7]Murphy VE, Namazy JA, Powell H, Schatz M, Chambers C, Attia J, Gibson PG. A meta-analysis of adverse perinatal outcomes in women with asthma. BJOG. 2011; 118:1314-1323.
• [8]Rejno G, Lundholm C, Gong T, Larsson K, Saltvedt S, Almqvist C. Asthma during pregnancy in a population-based study - pregnancy complications and adverse perinatal outcomes. PLoS One. 2014; 9: Article ID e104755
• [9]Mendola P, Laughon SK, Mannisto TI, Leishear K, Reddy UM, Chen Z, Zhang J. Obstetric complications among US women with asthma. Am J Obstet Gynecol. 2013;208:127 e121–28.
• [10]Lim AS, Stewart K, Abramson MJ, Walker SP, Smith CL, George J. Multidisciplinary approach to management of maternal asthma (MAMMA): a randomized controlled trial. Chest. 2014; 145:1046-1054.
• [11]Zairina E, Stewart K, Abramson MJ, George J. The effectiveness of non-pharmacological healthcare interventions for asthma management during pregnancy: a systematic review. BMC Pulm Med. 2014; 14:46. BioMed Central Full Text
• [12]Bain E, Pierides KL, Clifton VL, Hodyl NA, Stark MJ, Crowther CA, Middleton P. Interventions for managing asthma in pregnancy. Cochrane Database Syst Rev. 2014; 10: Article ID CD010660
• [13]Gibson PG, Powell H, Coughlan J, Wilson AJ, Abramson M, Haywood P, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2003;(1):CD001117.
• [14]Gibson PG (ed.): Asthma and Telemedicine in: Monitoring Asthma; New South Wales,2005.p.107-131.
• [15]Rasmussen LM, Phanareth K, Nolte H, Backer V. Internet-based monitoring of asthma: a long-term, randomized clinical study of 300 asthmatic subjects. J Allergy Clin Immunol. 2005; 115:1137-1142.
• [16]Chan DS, Callahan CW, Sheets SJ, Moreno CN, Malone FJ. An Internet-based store-and-forward video home telehealth system for improving asthma outcomes in children. Am J Health Syst Pharm. 2003; 60:1976-1981.
• [17]Jan RL, Wang JY, Huang MC, Tseng SM, Su HJ, Liu LF. An internet-based interactive telemonitoring system for improving childhood asthma outcomes in Taiwan. Telemed J E Health. 2007; 13:257-268.
• [18]McLean S, Sheikh A. Does telehealthcare offer a patient-centred way forward for the community-based management of long-term respiratory disease? Prim Care Respir J. 2009; 18:125-126.
• [19]Finkelstein J, Cabrera MR, Hripcsak G. Internet-based home asthma telemonitoring: can patients handle the technology? Chest. 2000; 117:148-155.
• [20]Steel S, Lock S, Johnson N, Martinez Y, Marquilles E, Bayford R. A feasibility study of remote monitoring of asthmatic patients. J Telemed Telecare. 2002; 8:290-296.
• [21]Bratton RL. Patient and physician satisfaction with telemedicine for monitoring vital signs. J Telemed Telecare. 2001; 7 Suppl 1:72-73.
• [22]Zhao J, Zhai YK, Zhu WJ, Sun DX. Effectiveness of Telemedicine for Controlling Asthma Symptoms: A Systematic Review and Meta-analysis. Telemed J E Health. 2014;21(6):484–92.
• [23]National Asthma council. Australia Asthma Handbook, quick reference guideline, version 1.0.2014. http://asthmahandbook. org.au webcite
• [24]Saghaei M. Random allocation software for parallel group randomized trials. BMC med res methodol. 2004; 4:26. BioMed Central Full Text
• [25]GINA Report. Global strategy for asthma management and prevention. From the Global Strategy for Asthma (GINA).2015 [http://www.ginasthma.org/] 2015.
• [26]Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999; 14:902-907.
• [27]Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the mini asthma quality of life questionnaire. Eur Respir J. 1999; 14:32-38.
• [28]Goeman D, Jenkins C, Crane M, Paul E, Douglass J. Educational intervention for older people with asthma: a randomised controlled trial. Patient Educ Couns. 2013; 93:586-595.
• [29]Juniper EF, Bousquet J, Abetz L, Bateman ED. Identifying 'well-controlled' and 'not well-controlled' asthma using the asthma control questionnaire. Respir Med. 2006; 100:616-621.