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Trial registered on ANZCTR


Trial ID
ACTRN12613000800729
Ethics application status
Approved
Date submitted
15/07/2013
Date registered
17/07/2013
Date last updated
7/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of Asthma with Supportive Telehealth of Respiratory function in Pregnancy (MASTERY [copyright])
Scientific title
Management of Asthma with Supportive Telehealth of Respiratory function in Pregnancy (MASTERY [copyright]): the effectiveness of a telehealth support intervention compared to usual care on maternal and neonatal outcomes in pregnant women with asthma aged 18 years and above
Secondary ID [1] 282736 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MASTERY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 289469 0
Condition category
Condition code
Respiratory 289783 289783 0 0
Asthma
Reproductive Health and Childbirth 289947 289947 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 287399 0
Prevention
Intervention code [2] 287400 0
Behaviour
Intervention code [3] 287499 0
Treatment: Devices
Comparator / control treatment
The control group will receive usual medical care provided by the antenatal clinics and/or their health professionals. If during the follow up, their asthma control becomes a concern (two or more documented exacerbations without resolution i.e. increase in preventer dose) since prior assessment, we will notify the participant and her General Practitioner (with participant’s permission). The control group will be given a summary version of the “Asthma and Pregnancy” brochure from the National Asthma Council of Australia to provide information on the risks of poorly-controlled asthma.
Control group
Active

Outcomes
Primary outcome [1] 289871 0
Asthma control as measured by Juniper's Asthma Control Questionnaire (ACQ)
Timepoint [1] 289871 0
at baseline and at 3 months and 6 months from recruitment
Secondary outcome [1] 303437 0
Quality of life on Juniper's Mini Asthma quality of Life scale
Timepoint [1] 303437 0
at baseline and at 3 months and 6 months from recruitment
Secondary outcome [2] 303440 0
Asthma-related health visits - assessed via medical records and/or particpant self-report
Timepoint [2] 303440 0
at baseline and at 3 months and 6 months from recruitment
Secondary outcome [3] 303441 0
Preventer to reliever use ratio - assessed via pharmacy records and/or participant self-report
Timepoint [3] 303441 0
at baseline and at 3 months and 6 months from recruitment
Secondary outcome [4] 303442 0
Asthma-related days off work/study - assessed via medical records and/or participant self-report
Timepoint [4] 303442 0
at baseline and at 3 months and 6 months from recruitment
Secondary outcome [5] 303443 0
Gestational age of the baby at delivery - assessed via medical records
Timepoint [5] 303443 0
within 7 days of delivery
Secondary outcome [6] 303444 0
Development of antenatal complications, such as hypertensive disorders of preganancy, antepartum haemorrhage and gestational diabetes - assessed via medical records
Timepoint [6] 303444 0
within 7 days of delivery
Secondary outcome [7] 303445 0
Neonate's birth weight centile at delivery - assessed via medical records
Timepoint [7] 303445 0
within 7 days of delivery
Secondary outcome [8] 303446 0
Appearance Pulse Grimace Activity and Respiratory (APGAR) scores at delivery - assessed via medical records
Timepoint [8] 303446 0
within 7 days of delivery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women with asthma who are unable to communicate in English or cannot use a smart mobile phone (iPhone or Android)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure that sample size is reached efficiently, the following recruitment methods will be used: (1) A list of new pregnant women who have had their first outpatient antenatal visit will be generated weekly from the BOS/IPM (registered trademark) database (a medical records’ database which stores antenatal information for all hospital patients). One day before the clinic, the researchers will search the outpatient files and screen the medical records for pregnant women with asthma based on the GPs referrals(2) The researchers will also search for potential participants in the antenatal clinics by screening their medical records once the women have been seen by the midwives or physicians (3) Advertisement posters about the study will be placed in the outpatient department alongside a short explanation about the study and an expression of interest box where participants can leave their contact details. Simple computer generated randomisation will be carried out using the sealed opaque envelope method to conceal allocation of participants to the Telehealth program supported by a handheld respiratory device group (intervention) or the usual care group (control).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be randomly assigned to intervention or control groups with the help of an independent person who is not involved in the project. Participants will be randomised to the control and intervention group using a random allocation software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A sample size of 28 women per arm using an estimated standard deviation of 0.66 will have 80% power with a two sided 5% significance level to detect the Minimal Important Difference (MID) in ACQ score of 0.5 or more between groups. To allow for 25% attrition, 35 participants will be recruited in each arm.
An intention-to-treat analysis will be performed for the main analysis. A per protocol analysis will also be undertaken as a sensitivity analysis. Pre-specified changes in outcome measures between groups from baseline will be compared using appropriate univariate analysis (t-test, Mann-Whitney U test, etc. depending on the distribution of data). We will compare the change in ACQ scores between baseline, 3 months and 6 months, proportion of participants whose ACQ score improves more than 0.5 (the Minimum Clinically Importance Difference [MCID]) over the study period, the proportion in whom asthma remained “not well controlled” (ACQ score is 1.5 or greater) and those whose asthma was “well controlled” (ACQ score is less than 1.5) at each time point.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1162 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 1163 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 7009 0
3084 - Heidelberg
Recruitment postcode(s) [2] 7011 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 287513 0
University
Name [1] 287513 0
Monash Research Impact Fund (MRIF)
Address [1] 287513 0
Centre for Medicine Use and Safety, Faculty of Pharmacy & Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, 3052, Victoria, Australia.
Country [1] 287513 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Centre for Medicine Use and Safety, Faculty of Pharmacy & Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, 3052, Victoria, Australia.
Country
Australia
Secondary sponsor category [1] 286254 0
None
Name [1] 286254 0
Address [1] 286254 0
Country [1] 286254 0
Other collaborator category [1] 277480 0
Hospital
Name [1] 277480 0
Mercy Hospital for women
Address [1] 277480 0
163 Studley Road, Heidleberg, VIC 3084
Country [1] 277480 0
Australia
Other collaborator category [2] 277481 0
Hospital
Name [2] 277481 0
Austin Hospital
Address [2] 277481 0
145 Studlety Road, Heidelberg, VIC 3084
Country [2] 277481 0
Australia
Other collaborator category [3] 277482 0
Hospital
Name [3] 277482 0
The Royal Women's Hospital
Address [3] 277482 0
20 Flemington Rd, Parkville VIC 3052
Country [3] 277482 0
Australia
Other collaborator category [4] 277483 0
Commercial sector/Industry
Name [4] 277483 0
Vitalograph Inc.
Address [4] 277483 0
Maids Moreton, Buckingham, MK18 1 SW, ENGLAND
Country [4] 277483 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289491 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 289491 0
Mercy Hospital for Women
163 Studley Road, Heidleberg, VIC 3084
Ethics committee country [1] 289491 0
Australia
Date submitted for ethics approval [1] 289491 0
Approval date [1] 289491 0
07/03/2013
Ethics approval number [1] 289491 0
R13/01
Ethics committee name [2] 289492 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 289492 0
Monash University, Building 3E, Room 111, Clayton Campus, Wellington Road, Clayton, VIC 3800
Ethics committee country [2] 289492 0
Australia
Date submitted for ethics approval [2] 289492 0
Approval date [2] 289492 0
21/03/2013
Ethics approval number [2] 289492 0
CF13/778 - 2013000353
Ethics committee name [3] 289493 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [3] 289493 0
20 Flemington Rd, Parkville VIC 3052
Ethics committee country [3] 289493 0
Australia
Date submitted for ethics approval [3] 289493 0
03/07/2013
Approval date [3] 289493 0
Ethics approval number [3] 289493 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41034 0
Dr Johnson George
Address 41034 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade, Parkville, Victoria 3052, Australia
Country 41034 0
Australia
Phone 41034 0
+61 3 9903 9178
Fax 41034 0
+61 3 9903 9629
Email 41034 0
Johnson.George@monash.edu
Contact person for public queries
Name 41035 0
Dr Johnson George
Address 41035 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade, Parkville, Victoria 3052, Australia
Country 41035 0
Australia
Phone 41035 0
+61 3 9903 9178
Fax 41035 0
+61 3 9903 9629
Email 41035 0
Johnson.George@monash.edu
Contact person for scientific queries
Name 41036 0
Dr Johnson George
Address 41036 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade, Parkville, Victoria 3052, Australia
Country 41036 0
Australia
Phone 41036 0
+61 3 9903 9178
Fax 41036 0
+61 3 9903 9629
Email 41036 0
Johnson.George@monash.edu