None listed
Conditions
Brief summary
Background: Poorly controlled asthma during pregnancy may harm both the baby and the mother, causing an increased risk of pre-eclampsia, prematurity, low birth weight and perinatal mortality . More than half of pregnant women do not take their preventer medications on a regular basis before and during pregnancy leading to asthma exacerbations. Evidence shows that better asthma control will be achieved if patients are involved in self-management, including regular self-monitoring of symptoms and/or lung function. This study will examine the potential for enhanced telehealth support for asthma in pregnancy. Telehealth may provide an attractive alternative to standard medical care for pregnant women with asthma. As well as providing accessibility and flexibility for patients, other potential benefits include reduced time to access healthcare services, reduced travel costs, earlier detection of worsening asthma such as exacerbations and reduced healthcare visits/hospitalisations. However, there are only a few well conducted studies in Australia providing evidence on the applications of telehealth for any condition. Aims: To develop a telehealth program for asthma management and to trial its effectiveness in pregnant women with asthma. We hypothesise that telehealth for supporting management of asthma during pregnancy will result in better asthma control, better quality of life, better maternal and better neonatal outcomes compared to the usual care Methods: A mobile phone application (Breathe-easy [copyright]) will be developed to facilitate communication between patients and their health professionals. Patient lung function data (measured using the COPD-6[copyright] device) will be transmitted daily via a mobile phone to a central server. Patients will receive automatic feedback on their mobile phones according to an individualised algorithm. The GP/Obstetrician will be notified when an unscheduled visit and/or change in medication is needed.
Interventions
Arm1: The trial tests an intervention involving a telehealth program supported by a handheld respiratory device (COPD-6)[copyright]. The intervention group will be provided with a COPD-6 and a specifically designed Breathe-easy [copyright] application installed on their mobile phone. They will be asked to measure their lung function (FEV1 and FEV6) using the COPD-6 device twice daily and to record their asthma symptoms and medication usage in Breathe-easy [copyright]. The lung function data (FE
Arm1: The trial tests an intervention involving a telehealth program supported by a handheld respiratory device (COPD-6)[copyright]. The intervention group will be provided with a COPD-6 and a specifically designed Breathe-easy [copyright] application installed on their mobile phone. They will be asked to measure their lung function (FEV1 and FEV6) using the COPD-6 device twice daily and to record their asthma symptoms and medication usage in Breathe-easy [copyright]. The lung function data (FEV1 and FEV6) will be transmitted to a central server and reviewed by the researcher daily. The data will also be sent to participants’ General Practitioners (GPs). Participants and the research team will have secure access to the online portal. Any clinically significant reduction in lung function will be brought to the attention of the participants' GPs in order for them to determine if any medication changes or unscheduled visit related to asthma are needed. The total duration of the intervention will be 7 - 9 months depending on when the participants had their first antenatal visit. Arm 2: Usual care
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
All pregnant women aged 18 years and older who can communicate in English. Participants will be included if they have asthma and used any asthma medications in 12 months before pregnancy and/or during their current pregnancy
Exclusion criteria
Pregnant women with asthma who are unable to communicate in English or cannot use a smart mobile phone (iPhone or Android)
Outcome results
None listed