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Trial registered on ANZCTR


Registration number
ACTRN12613000580774
Ethics application status
Approved
Date submitted
21/05/2013
Date registered
23/05/2013
Date last updated
23/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Maternal Pertussis Randomised Control Trial: best practice for the communication of pertussis booster vaccine recommendations to new mothers.
Scientific title
The influence of baseline attitudes, modifiable factors and health message framing on whooping cough booster vaccine uptake among new mothers on the postnatal ward.
Secondary ID [1] 282543 0
Nil Known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pertussis 289212 0
Condition category
Condition code
Reproductive Health and Childbirth 289546 289546 0 0
Childbirth and postnatal care
Public Health 289547 289547 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health-message framing: The tri-fold, coloured A4 pamphlet was written either in a gain or loss frame, indicating either what mothers gain from the cocooning strategy or what mothers would lose by not receiving the pertussis booster vaccine (for adults). The intervention was administered by the research nurse once the baseline questionnaire was completed. Allocation concealment was implement by placing the pamphlet in an opaque envelope. The interventions ( gain or loss pamphlet) were allocated to participants using random block allocation by week.
Intervention code [1] 287213 0
Behaviour
Comparator / control treatment
The control was the standard NSW Health pertussis facts sheet (A4, double sided). The printed factsheet was accessed from http://www.health.nsw.gov.au/factsheets/infectious/pertussis.html (Date: 14/SEPT/2009) and was the only available pertussis resource at the commencement of the study.

The control pamphlet was placed in an opaque envelope. It was distributed by a research nurse (blinded) once the participant had completed the questionnaire. Random block allocation by week was used.
Control group
Active

Outcomes
Primary outcome [1] 289639 0
Pertussis booster vaccine uptake by postpartum women, assessed by follow up questionnaire completed prior to discharge.
Timepoint [1] 289639 0
Immediate postpartum period (prior to discharge from hospital following childbirth).
Secondary outcome [1] 302924 0
Baseline attitude and other factors influencing vaccine uptake were assessed using a self-administered, web-based questionnaire completed on an Apple Ipad (Registered Trademark) at the participant's bedside.

The questionnaire was comprised of 5 parts structure according to the Health Belief Model framework, with questions on: a) pertussis vaccination information sources b) pertussis susceptibility and severity c) vaccine benefits and barriers d) intentions to be vaccinated and e) demographic information.
Timepoint [1] 302924 0
At baseline (following completion of the baseline questionnaire, prior to allocation of the intervention or control).
Secondary outcome [2] 302970 0
Additional follow up ( by preferred method of phone or email) to assess household pertussis vaccine status and household exposure to pertussis and/or epidsode/s of pertussis.
Timepoint [2] 302970 0
six months postpartum

Eligibility
Key inclusion criteria
Postpartum women not up to date with pertussis booster recommendations ( dTpa <10 years)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Requires an interpreter.
Unable to given written informed consent.

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)
All postpartum women present during recruitment days ( 2 week days) are approached sequentially (room by room on the postnatal ward) by the research nurse. Following consent, an electronic, web-based self-administered baseline questionnaire is completed on an Apple Ipad (Registered Trademark). Next, the allocated intervention for that week, concealed in an opaque envelope, is given to the participant by the research nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random block allocation by week, generated using a computerised random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of N=1080 is required to detect a difference between the gain-frame, loss-frame and control, with 80% confidence at the 0.05 level. This includes a 20% margin for non-response. Calculation based on vaccine coverage of 75%-80% post intervention.

Frequencies reported as percentages for all questions. Chi-square analysis to test for association of pertussis booster vaccine uptake and demographic, attitudinal, awareness and behavioural variables. Multiple logistic regression of significant variables in the univariate analysis is undertaken to determine predictors of vaccine uptake on the postnatal ward.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/03/2012
Date of last participant enrolment
Anticipated
9/09/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1080
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6910 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 287331 0
Commercial sector/Industry
Name [1] 287331 0
GlaxoSmithKline
Country [1] 287331 0
Australia
Primary sponsor type
Individual
Name
Associate Professor John Sinn
Address
Department of Neonatology
Level 5 Douglas Building
Royal North Shore Hospital
Pacific Highway,
St Leonards, NSW, 2065
Country
Australia
Secondary sponsor category [1] 286078 0
None
Name [1] 286078 0
Address [1] 286078 0
Country [1] 286078 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40246 0
A/Prof John Sinn
Address 40246 0
Department of Neonatology
level 5 Douglas Building
Royal North Shore Hospital
Pacific Highway,
St Leonards, NSW, 2065
Country 40246 0
Australia
Phone 40246 0
+61294632183
Fax 40246 0
Email 40246 0
john.sinn@sydney.edu.au
Contact person for public queries
Name 40247 0
Elizabeth Hayles
Address 40247 0
Department of Neonatology
level 5 Douglas Building
Royal North Shore Hospital
Pacific Highway,
St Leonards, NSW, 2065
Country 40247 0
Australia
Phone 40247 0
+61294632197
Fax 40247 0
Email 40247 0
ehay8329@uni.sydney.edu.au
Contact person for scientific queries
Name 40248 0
Elizabeth Hayles
Address 40248 0
Department of Neonatology
level 5 Douglas Building
Royal North Shore Hospital
Pacific Highway,
St Leonards, NSW, 2065
Country 40248 0
Australia
Phone 40248 0
+61294632197
Fax 40248 0
Email 40248 0
ehay8329@uni.sydney.edu.au

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.

Documents added automatically
No additional documents have been identified.