Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000681853
Ethics application status
Approved
Date submitted
23/06/2012
Date registered
26/06/2012
Date last updated
26/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Multidisciplinary Approach to Management of Maternal Asthma (MAMMA [Copyright])
Scientific title
Multidisciplinary Approach to Management of Maternal Asthma (MAMMA [copyright]): the effects of a pharmacist-led intervention involving asthma education and monthly monitoring during pregnancy on asthma outcomes and obstetric and neonatal complications in pregnant women with asthma aged 18 years and older
Secondary ID [1] 280727 0
none
Universal Trial Number (UTN)
Trial acronym
MAMMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 286774 0
Condition category
Condition code
Respiratory 287080 287080 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial tests an intervention involving a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA[copyright]). This intervention will embrace a collaborative approach involving the participants’ family physician, pharmacist and asthma educator. Asthma education, monitoring, feedback and follow-up are integral components of the monthly intervention. Every month, participants in the intervention group will be contacted for an hour session by the trial’s nominated pharmacist to assess their asthma control by administrating Juniper's Asthma Control Questionnaire (ACQ) and a short data collection form which inquires about oral corticosteroid use, asthma related hospital admissions and days off work and preventer to reliever use ratio. They will be followed up every month till delivery (7-9 months duration depending on when they had their first outpatient visit). The ACQ states that an increase in a score of 0.5 is a clinically significant deterioration of asthma control. The trial’s pharmacist will feedback to the participant’s nominated family physician if their ACQ score has increased by 0.5 or greater and if there has been a documented exacerbation since the last monthly visit. The pharmacist and family physician will then collaborate on appropriate step up therapy for the participant. It is anticipated that this close monthly monitoring will maintain the participant’s asthma under tight control during pregnancy. Each participant in the intervention group will be given a handheld device (PiKo-6) for home monitoring of lung function which they can use as often as they please but we will ask for their latest result at the monthly visits. They will receive a medication management review, periodic review of inhaler device technique, instruction in the use of PiKo-6, trigger avoidance and smoking cessation support (if relevant). The intervention group will also have their FEV1/FEV6 observed during the trial every month. This information will be oberservational data only as we are exploring this value as a marker for asthma control during pregnancy. We will not be using this ratio to determine medication dosage changes during the trial.
Intervention code [1] 285149 0
Prevention
Intervention code [2] 285150 0
Behaviour
Intervention code [3] 285151 0
Treatment: Other
Comparator / control treatment
Standard usual care. Women in the control group will continue having their regular outpatient visits at the antenatal clinics as per usual (ranging from monthly to weekly depending on their obstetrician's discretion). They will receive no intervention. The only form of education they will receive during the trial is an "Asthma during pregnancy" education pamphlet at the start of the trial which is written by the Asthma Foundation of New South Wales. Unlike the control group, they will not receive any asthma monitoring or additional education.
Control group
Active

Outcomes
Primary outcome [1] 287405 0
Asthma control score on Juniper's asthma control questionnaire (ACQ)
Timepoint [1] 287405 0
Baseline, 3 and 6 months from recruitment
Secondary outcome [1] 298076 0
Asthma-related hospital visits - assessed via medical records and/or participant self report
Timepoint [1] 298076 0
Baseline, 3 and 6 months from recruitment
Secondary outcome [2] 298093 0
Asthma related days off work-assessed via medical records and/or participant self report
Timepoint [2] 298093 0
Baseline, 3 and 6 months from recruitment
Secondary outcome [3] 298094 0
asthma related oral corticosteroid use - assessed via medical records and/or participant self report
Timepoint [3] 298094 0
Baseline, 3 and 6 months from recruitment
Secondary outcome [4] 298095 0
Preventer to reliever use ratio - assessed via participant self report and/or prescription records
Timepoint [4] 298095 0
Baseline, 3 and 6 months from recruitment
Secondary outcome [5] 298096 0
Development of antenatal complications, such as hypertensive disorders of pregnancy, antepartum haemorrhage and gestational diabetes - assessed via medical records and/or participant self report
Timepoint [5] 298096 0
Shortly after delivery
Secondary outcome [6] 298097 0
Gestational age of the baby at delivery - assessed via medical records
Timepoint [6] 298097 0
Shortly after delivery
Secondary outcome [7] 298098 0
Neonate's birth weight percentile at delivery - assessed via medical records
Timepoint [7] 298098 0
Shortly after delivery
Secondary outcome [8] 298099 0
Appearance Pulse Grimace Activity and Respiratory (APGAR) scores at delivery - assessed via medical records
Timepoint [8] 298099 0
Shortly after delivery
Secondary outcome [9] 298100 0
Mode of delivery - assessed by medical records
Timepoint [9] 298100 0
Shortly after delivery
Secondary outcome [10] 298101 0
Incidences of any postnatal complications - assessed via medical records
Timepoint [10] 298101 0
Shortly after delivery
Secondary outcome [11] 298102 0
Admission to neonatal intensive care or special care nursery - assessed via medical records
Timepoint [11] 298102 0
Shortly after delivery

Eligibility
Key inclusion criteria
All pregnant women 18 years and older who can communicate in English and have agreed to be approached for research will be included. Participants will be included if they have had asthma symptoms in the last ten years.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unlikely to meet the demands of the trial will be excluded (e.g. patients who expect to relocate during the trial). Patients who were previously involved in the project titled “Qualitative in depth interviews with pregnant asthmatic women” which has the Mercy Health Human Research Ethics Committee project number - (R11/15) will also be excluded. If there is an event such as a miscarriage or termination of pregnancy during the trial, the participant will be removed from the trial. Participants who have not had asthma symptoms in the last ten years will also be excluded.

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)
Three recruitment methods will be used to ensure the sample size is reached efficiently.
1. Advertisement posters publicising the trial will be placed in the outpatient department along side an expression of interest box where participants can leave their contact details. Study packs (includes an explanatory statement with an expression of interest form and a reply paid envelope) will also be available in the outpatient department so potential participants can take the information home to read and post back expression of interest forms.
2. Midwives will also be asked to help identify eligible pregnant women with asthma during their first outpatient visit. They will be asked to approach any woman who has indicated they are asthmatic and hand them a study pack, which will be available in the outpatient department. Midwives will only be identifying women. Our researchers will seek consent after receiving expression of interest forms. Midwives will be notified of this study through email.
3. A list of pregnant asthmatic women who have had their first outpatient visit will be generated weekly from the BOS (registered trademark)/IPM (registered trademark) database (a medical records’ database which stores antenatal information for all hospital patients). Study packs will be posted to the women who are on each weekly list.

During the recruitment phase, each participant will be asked to nominate their preferred family physician to be involved in the trial and to bear the responsibility of their asthma management during pregnancy.

Group allocation
At time of consent, participants asthma severity will be assessed in accordance with the National Asthma Handbook classifications and randomisation will be stratified according to asthma severity. Participants will be allocated to three groups; mild intermittent asthmatics, moderate-persistent asthmatics and severe-persistent asthmatics. Within these strata, simple randomization will be conducted using the sealed opaque envelope method to allocate participants to the usual care group (UCG) or the multidisciplinary care group (MCG), to ensure a balance of asthma severities between groups. Outcome assessors will be blinded to participant group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting pregnant asthmatic women will be randomly assigned to intervention and control groups by an investigator with the help of numbered envelopes. The envelope numbers for each participant will be decided by simple number sequence generation using Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5417 0
3084

Funding & Sponsors
Funding source category [1] 285510 0
Self funded/Unfunded
Name [1] 285510 0
Country [1] 285510 0
Primary sponsor type
University
Name
Monash University
Address
Centre of Medicine Use and Safety
381 Royal Parade Parkville 3081
Victoria
Country
Australia
Secondary sponsor category [1] 284349 0
Hospital
Name [1] 284349 0
Mercy Hospital for Women
Address [1] 284349 0
163 Studley rd
Heidelberg 3084
Victoria
Country [1] 284349 0
Australia
Other collaborator category [1] 276879 0
Hospital
Name [1] 276879 0
Mercy Hospital for Women
Address [1] 276879 0
163 Studley rd
Heidelberg 3084
Victoria
Country [1] 276879 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287524 0
Mercy Health Research Ethics Commitee
Ethics committee address [1] 287524 0
Mercy Hospital for Women
163 Studley Rd
Heidelberg 3084
Victoria, Australia
Ethics committee country [1] 287524 0
Australia
Date submitted for ethics approval [1] 287524 0
Approval date [1] 287524 0
31/05/2012
Ethics approval number [1] 287524 0
R12/13
Ethics committee name [2] 287525 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 287525 0
Monash University
Clayton Campus
Building 3E, Room 111, Clayton 3800
Ethics committee country [2] 287525 0
Australia
Date submitted for ethics approval [2] 287525 0
Approval date [2] 287525 0
22/06/2012
Ethics approval number [2] 287525 0
2012000921

Summary
Brief summary
Background: Uncontrolled asthma during pregnancy is associated with the maternal hazards of disease exacerbation, and perinatal hazards including intrauterine growth restriction and preterm birth. Interventions directed at achieving better asthma control during pregnancy should be considered a high priority in order to optimise both maternal and perinatal outcomes. Poor compliance with prescribed asthma medications during pregnancy and suboptimal prescribing patterns to pregnant women have both been shown to be contributing factors that jeopardise asthma control. The aim is to design and evaluate an intervention involving multidisciplinary care for women experiencing asthma in pregnancy.

Methods/Design: A randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA[copyright]) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics of one maternity hospital in Victoria, Australia. Recruited participants, stratified by disease severity, will be allocated to the intervention or the usual care group in a 1:1 ratio. Both groups will be followed prospectively throughout pregnancy and outcomes will be compared between groups at three and six months after recruitment to evaluate the effectiveness of this intervention. Outcome measures include Asthma Control Questionnaire (ACQ) scores, oral corticosteroid use, asthma exacerbations and asthma related hospital admissions, and days off work, preventer to reliever ratio, along with pregnancy and neonatal adverse events at delivery. The use of FEV1/FEV6 will be also investigated during this trial as a marker for asthma control.

Discussion: If successful, this model of care could be widely implemented in clinical practice and justify more funding for support services and resources for these women. This intervention will also promote awareness of the risks of poorly controlled asthma and the need for a collaborative, multidisciplinary approach to asthma management during pregnancy. This is also the first study to investigate the use of FEV1/FEV6 as a marker for asthma control during pregnancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34357 0
Address 34357 0
Country 34357 0
Phone 34357 0
Fax 34357 0
Email 34357 0
Contact person for public queries
Name 17604 0
Dr Johnson George
Address 17604 0
Centre of Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash Univeristy
381 Royal Parade
Parkville, Victoria 3081
Country 17604 0
Australia
Phone 17604 0
+ 61 3 9903 9178
Fax 17604 0
Email 17604 0
[email protected]
Contact person for scientific queries
Name 8532 0
Dr Johnson George
Address 8532 0
Centre of Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash Univeristy
381 Royal Parade
Parkville, Victoria 3081
Country 8532 0
Australia
Phone 8532 0
+ 61 3 9903 9178
Fax 8532 0
Email 8532 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

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