Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000893707
Ethics application status
Approved
Date submitted
7/08/2013
Date registered
12/08/2013
Date last updated
12/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Maternal Pertussis Study: best practice for the communication of pertussis (whooping cough) 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 in a public hospital.
Secondary ID [1] 282988 0
Nil
Universal Trial Number (UTN)
Nil Known
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pertussis 289815 0
Condition category
Condition code
Reproductive Health and Childbirth 290165 290165 0 0
Childbirth and postnatal care
Public Health 290166 290166 0 0
Health promotion/education
Infection 290182 290182 0 0
Other infectious diseases

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. The interventions ( gain or loss pamphlet) were allocated to participants using sequential block allocation by week.
Intervention code [1] 287700 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.
Control group
Active

Outcomes
Primary outcome [1] 290193 0
Pertussis booster vaccine uptake by postpartum women, assessed by follow up questionnaire completed prior to discharge.
Timepoint [1] 290193 0
Immediate postpartum period (prior to discharge from hospital following childbirth).
Secondary outcome [1] 304084 0
Baseline attitude and other factors influencing vaccine uptake were assessed using a self-administered, paper-based questionnaire completed 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] 304084 0
At baseline (following completion of the baseline questionnaire, prior to allocation of the intervention or control).
Secondary outcome [2] 304085 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] 304085 0
from 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All postpartum women present during recruitment days ( 3 week days) are approached sequentially (room by room on the postnatal ward) by the research nurse. Following consent, an paper-based, self-administered baseline questionnaire is completed. Next, the allocated intervention for that week is given to the participant by the research nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequential block allocation by week
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
1/11/2010
Date of last participant enrolment
Anticipated
31/03/2012
Actual
30/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
1080
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1426 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 7260 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 287758 0
Commercial sector/Industry
Name [1] 287758 0
Sanofi Pasteur Pty Limited
Country [1] 287758 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] 286483 0
None
Name [1] 286483 0
Address [1] 286483 0
Country [1] 286483 0
Other collaborator category [1] 277568 0
Government body
Name [1] 277568 0
National Centre for Immunisation Research and Survelliance
Address [1] 277568 0
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St, Westmead
NSW, 2145
Country [1] 277568 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289705 0
HARBOUR HREC (NSCCH)
Ethics committee address [1] 289705 0
Ethics committee country [1] 289705 0
Australia
Date submitted for ethics approval [1] 289705 0
23/02/2010
Approval date [1] 289705 0
24/06/2010
Ethics approval number [1] 289705 0
0905-087M

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

Contacts
Principal investigator
Name 42058 0
A/Prof John Sinn
Address 42058 0
Department of Neonatology level 5 Douglas Building Royal North Shore Hospital Pacific Highway, St Leonards, NSW, 2065
Country 42058 0
Australia
Phone 42058 0
+61294632183
Fax 42058 0
Email 42058 0
[email protected]
Contact person for public queries
Name 42059 0
Elizabeth Hayles
Address 42059 0
Department of Neonatology level 5 Douglas Building Royal North Shore Hospital Pacific Highway, St Leonards, NSW, 2065
Country 42059 0
Australia
Phone 42059 0
+61294632197
Fax 42059 0
Email 42059 0
[email protected]
Contact person for scientific queries
Name 42060 0
Elizabeth Hayles
Address 42060 0
Department of Neonatology level 5 Douglas Building Royal North Shore Hospital Pacific Highway, St Leonards, NSW, 2065
Country 42060 0
Australia
Phone 42060 0
+61294632197
Fax 42060 0
Email 42060 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.

Documents added automatically
No additional documents have been identified.