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Trial registered on ANZCTR


Registration number
ACTRN12613000244707
Ethics application status
Approved
Date submitted
27/02/2013
Date registered
28/02/2013
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Antenatal Asthma Management Service (AAMS)
Scientific title
A randomised controlled trial to assess the clinical and cost effectiveness of a nurse-led Antenatal Asthma Management Service (AAMS) for reducing asthma exacerbations during pregnancy
Secondary ID [1] 282031 0
None
Universal Trial Number (UTN)
Trial acronym
AAMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 288480 0
Pregnancy 288481 0
Condition category
Condition code
Respiratory 288826 288826 0 0
Asthma
Reproductive Health and Childbirth 288827 288827 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive care through the nurse-led Antenatal Asthma Management Service, based in the antenatal outpatient clinic. The Antenatal Asthma Management Service will be led by a respiratory nurse with qualifications in asthma management and education and spirometry. All asthmatic women will receive asthma education with a full assessment of their asthma at 18, 24, 30 and 36 weeks gestation conducted by a respiratory nurse. Each antenatal visit will include a 60-90 min session where asthma management skills are assessed including: medication adherence and knowledge, inhaler device technique, recognition of asthma deterioration and possession of a written asthma action plan. In addition, subjects will receive education about asthma control and management skills including trigger avoidance and smoking cessation counseling when appropriate. While it is standard antenatal care for all pregnant women to complete a smoking questionnaire at their first booking visit and be encouraged to quit smoking, an additional key component of the Antenatal Asthma Management Service will be in providing additional counseling on the importance of smoking cessation in relation to their asthma and the health of their baby. Women will be provided with information on the benefits of smoking cessation and direct referrals will be made to QuitSA for cessation support.
During the first visit at 18 weeks gestation, all subjects will be provided with an individualized written asthma action plan, which has been developed according to evidence based principles by the asthma educator using a standardized template following National Asthma Council recommendations. In addition, current asthma management therapies will be evaluated and recommendations regarding optimal therapy will be made. If women are identified at their first antenatal visit as having unstable asthma, as determined by the Juniper Asthma Control Questionnaire (ACQ) score of >1.5 a recommendation will be made for step-up therapy in accordance with well-established clinical guidelines and previous studies. If inhaled corticosteroids need to be prescribed an on-call respiratory physician will be contacted. A detailed asthma management report, including asthma action plan and recommended changes in therapy if required, will be forwarded to the participant’s preferred family physician (i.e. general practitioner) who will review each action plan and assess the appropriateness of recommended changes in therapy. This preferred provider will be the lead clinician responsible for her asthma management during pregnancy. All recommendations made through the Antenatal Asthma Management Service will be recorded and followed-up to determine their outcome (i.e. acceptance of recommendation).
During subsequent visits to the Antenatal Asthma Management Service, the respiratory nurse will continually review asthma control and management plans. Subjects assessed as having poor asthma control (ACQ>1.5) or experiencing a current exacerbation will be referred to their usual family physician in the community or respiratory physician in the hospital for appropriate review. During antenatal appointments urgent medical review will be available for patients with an acute exacerbation. The respiratory nurse and designated family physician and/or respiratory physician will collaborate closely on appropriate step-up therapy for the participant.
Between visits, participants will be encouraged to follow their asthma action plan closely and see their family doctor if their asthma worsens. Those subjects who also attend specialist respiratory clinics will also have information forwarded to their physician for reference. Subjects will be encouraged to maintain these specialist visits. During the study, care received for asthma management from a GP, obstetrician or respiratory specialist will be noted.
Intervention code [1] 286618 0
Treatment: Other
Intervention code [2] 286619 0
Behaviour
Intervention code [3] 286620 0
Prevention
Comparator / control treatment
Standard care will be as outlined in the SA Perinatal Practice Guideline for the treatment of asthma during pregnancy. This involves women with asthma self managing their disease during pregnancy and seeking guidance for asthma management when required from a midwife, obstetrician, respiratory physician or GP. Some women in this group will already be managed by a respiratory specialist and this will be continued. Women in the control group will be provided with an education pamphlet on asthma in pregnancy, but will not receive formalised asthma education.
Control group
Active

Outcomes
Primary outcome [1] 288961 0
Asthma Exacerbations (moderate and severe) defined as events for which the participant sought medical attention (i.e. an unscheduled visit to a doctor, presentation to the emergency department room or admission to hospital, or when oral corticosteroids were used for treatment of asthma)
Timepoint [1] 288961 0
From randomisation until delivery
Secondary outcome [1] 301448 0
Neonatal birth weight as determined by data abstracted from delivery case notes
Timepoint [1] 301448 0
Delivery
Secondary outcome [2] 301449 0
Asthma control score on Juniper's asthma control questionnaire (ACQ6)
Timepoint [2] 301449 0
Baseline, 24, 30 and 36 weeks gestation
Secondary outcome [3] 301450 0
Asthma related quality of life measured using the Mini Asthma Quality of Life Questionnaire
Timepoint [3] 301450 0
Baseline, 24, 30 and 36 weeks gestation
Secondary outcome [4] 301451 0
Pregnancy complications, such as antepartum haemorrhage, hypertensive disorders of pregnancy, gestational diabetes, preterm labour, antenatal hospitalisation, postpartum haemorrhage as determined by obstetric history collected at 24, 30 and 36 weeks gestation and data abstracted from delivery case notes
Timepoint [4] 301451 0
Baseline, 24, 30, 36 weeks gestation and Delivery
Secondary outcome [5] 301452 0
Adverse neonatal outcomes, such as preterm delivery, low birth weight, small for gestational age, intrauterine growth restriction, stillbirth, congenital malformation, admission to neonatal intensive care unit or special care nursery as determined by data abstracted from delivery case notes
Timepoint [5] 301452 0
Delivery

Eligibility
Key inclusion criteria
To be eligible, participants must be less than 18 weeks gestation at the time of recruitment, have asthma which has been previously diagnosed by a doctor and is not currently in remission (remission defined as no asthma symptoms and no use of asthma medications in previous year), aged 18-45 years, expected to give birth to a singleton and be able to speak English.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they have previously participated in an Asthma study run at the hospital or have a pre-existing chronic medical condition (i.e. diabetes, hypertension, cardiac disease, HIV/hepatitis, renal disease, haematology disorder (i.e. thalassaemia, thrombophilia), thyroid disorder, psychiatric disease requiring therapy with antidepressant or antipsychotic, epilepsy).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All pregnant women with asthma attending their first booking visit (approximately 12 weeks gestation) at the antenatal outpatient clinic will be identified by the attending midwife. The midwife will ask several questions to establish the presence of asthma including “have you been told by a doctor that you have asthma? As well as “Have you used any asthma medications in the last year such as ventolin or a preventer?” Women identified as having asthma will be referred by the attending midwife and will be subsequently interviewed by a research midwife associated with this study who will explain the project to them by providing both written and verbal information.

Following baseline data collection eligible women with asthma will be randomized into one of two study groups: either the ‘Standard Care Group’ or the ‘Intervention Group’. A telephone randomization service will use a randomization schedule with balanced variable blocks, prepared by an investigator not involved with recruitment or clinical care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A telephone randomization service will use a randomization schedule with balanced variable blocks, prepared by an investigator not involved with recruitment or clinical care. Stratification will be by parity and asthma severity. During the randomization call, eligibility will be checked and information collected to enable stratification and to assist in follow-up.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Baseline characteristics of all randomized women will be compared descriptively between the study groups. Outcome comparisons will be made according to the treatment allocation at randomization on an ‘intention to treat’ basis. Both adjusted and unadjusted analyses will be carried out. The difference in exacerbation rates between groups will be compared using a Poisson regression model. This will enable calculation of the incident rate ratio and associated 95% confidence interval.
For secondary outcomes, discrete outcomes (i.e. low birth weight) will be analysed using log binomial regression and continuous outcomes (i.e. birth weight, gestational age) analysed using linear regression. Continuous variables with repeated measurements (i.e. questionnaire results, ACQ score) will be analysed using a generalized linear mixed model (GLMM) with a random intercept for individuals to account for repeated measurements. Planned sub-analyses will be undertaken to assess the effects of asthma control, FEV1, asthma medication use, cumulative ICS exposure, asthma knowledge and medication adherence, on the primary and secondary outcomes. SPSS Version 20 will be used for analysis. Statistical significance will be assessed at the 0.05 level using a two-sided comparative test.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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)
SA
Recruitment hospital [1] 685 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 686 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 6433 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 6434 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 286807 0
Self funded/Unfunded
Name [1] 286807 0
Address [1] 286807 0
Country [1] 286807 0
Primary sponsor type
University
Name
The University of Adelaide
Address
The Robinson Institute
Level 2, Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, South Australia 5112
Country
Australia
Secondary sponsor category [1] 285597 0
Hospital
Name [1] 285597 0
Lyell McEwin Hospital
Address [1] 285597 0
Haydown Road
Elizabeth Vale, South Australia 5112
Country [1] 285597 0
Australia
Secondary sponsor category [2] 285599 0
Hospital
Name [2] 285599 0
Flinders Medical Centre
Address [2] 285599 0
Flinders Drive
Bedford Park, South Australia 5042
Country [2] 285599 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288874 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 288874 0
Basil Hetzel Institute
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 288874 0
Australia
Date submitted for ethics approval [1] 288874 0
Approval date [1] 288874 0
11/12/2012
Ethics approval number [1] 288874 0
HREC/12/TQEHLMH/73

Summary
Brief summary
Background: Pregnancy presents a unique situation for the management of asthma as it can alter the course of asthma severity and its treatment, which in turn can affect pregnancy outcomes. Despite awareness of the substantial adverse effects associated with asthma during pregnancy, little has been done to improve its management and reduce associated perinatal morbidity and mortality. The aim of this randomized controlled trial is to evaluate the clinical and cost effectiveness of an Antenatal Asthma Management Service (AAMS).
Methods/design: Design: Multicentre, randomized controlled trial
Inclusion criteria: Women with physician diagnosed asthma, which is not currently in remission, who are less than 18 weeks gestation with a singleton pregnancy and do not have a chronic medical condition.
Trial entry and randomization: Eligible women with asthma, stratified by disease severity, will be randomized into one of two study groups: either the ‘Standard Care Group’ or the ‘Intervention Group’
Study groups: Both groups will be followed prospectively throughout pregnancy. Women in the ‘Standard Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive additional care through the nurse-led Antenatal Asthma Management Service, based in the antenatal outpatient clinic. Women will receive asthma education with a full assessment of their asthma at 18, 24, 30 and 36 weeks gestation. Each antenatal visit will include a 60-90 min session where asthma management skills are assessed including: medication adherence and knowledge, inhaler device technique, recognition of asthma deterioration and possession of a written asthma action plan. In addition, subjects will receive education about asthma control and management skills including trigger avoidance and smoking cessation counseling when appropriate.
Primary study outcome: Asthma exacerbations during pregnancy.
Sample size: A sample size of 378 women will be sufficient to show an absolute reduction in asthma exacerbations during pregnancy of 20% (alpha 0.05 two-tailed, 90% power, 5% loss to follow-up).
Discussion: The integration of an adapted model of an asthma education program within the antenatal clinic setting has the significant potential to improve the participation rate of pregnant women in the self-management of their asthma, reduce asthma exacerbations and improve perinatal health outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38158 0
A/Prof Vicki Clifton
Address 38158 0
The Robinson Institute, The University of Adelaide
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, 5112
South Australia, Australia
Country 38158 0
Australia
Phone 38158 0
+61 8 8133 2133
Fax 38158 0
+61 8 8182 9337
Email 38158 0
Vicki.clifton@adelaide.edu.au
Contact person for public queries
Name 38159 0
A/Prof Vicki Clifton
Address 38159 0
The Robinson Institute, The University of Adelaide
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, 5112
South Australia, Australia
Country 38159 0
Australia
Phone 38159 0
+61 8 8133 2133
Fax 38159 0
+61 8 8182 9337
Email 38159 0
Vicki.clifton@adelaide.edu.au
Contact person for scientific queries
Name 38160 0
A/Prof Vicki Clifton
Address 38160 0
The Robinson Institute, The University of Adelaide
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, 5112
South Australia, Australia
Country 38160 0
Australia
Phone 38160 0
+61 8 8133 2133
Fax 38160 0
+61 8 8182 9337
Email 38160 0
Vicki.clifton@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
No Results