Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001381774
Ethics application status
Not yet submitted
Date submitted
9/12/2013
Date registered
17/12/2013
Date last updated
17/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving New Parents' Understanding of a Trial. The INPUT Study.
Scientific title
Can we improve parents’ understanding of a hypothetical clinical trial by using positive versus negative language in information leaflets? Randomised trial within a face to face questionnaire study.
Secondary ID [1] 283713 0
Nil
Universal Trial Number (UTN)
Trial acronym
INPUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Understanding of clinical trials 290675 0
Anxiety about clinical trials 290676 0
Willingness to participate in clinical trials 290677 0
Condition category
Condition code
Public Health 291045 291045 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The INPUT study proposed uses a randomised 2 x 3 x 2 factorial design to compare 12 different versions of an information leaflet describing an imaginary clinical trial in preterm infants. Parents will be randomly assigned to read one of 12 combinations of contrasting descriptions of (1) background risk, (2) the primary endpoint and (3) risks of participation, using 'negative', 'neutral' or 'positive' language. Through a face-to-face questionnaire performed immediately after reading the leaflet, the study will evaluate the effects of these contrasting expressions on the parents' level of understanding of a hypothetical clinical trial, their level of anxiety and their willingness to participate in the trial.
Intervention code [1] 288404 0
Behaviour
Comparator / control treatment
'Negative' language group such as 'death or disability' group versus 'positive' language group such as 'survival with normal ability'.
Control group
Active

Outcomes
Primary outcome [1] 291054 0
Parents' level of understanding of the hypothetical clinical trial will be measured using a previously validated questionnaire (Porteri et al, 2009) adapted for use in parents of newborn infants.
Timepoint [1] 291054 0
During completion of a 30 minute face to face questionnaire immediately after reading the information leaflet.
Secondary outcome [1] 305894 0
Parents' level of anxiety will be measured using the previously validated State­ Trait Anxiety Inventory State (Spielberger et al, 1977; O'Brien et al, 2013).
Timepoint [1] 305894 0
During completion of a 30 minute face to face questionnaire immediately after reading the information leaflet.
Secondary outcome [2] 305895 0
Parents' willingness to participate in the hypothetical clinical trial will be measured on a five part Likert Scale ranging from very unlikely to participate to very likely to participate.
Timepoint [2] 305895 0
During completion of a 30 minute face to face questionnaire immediately after reading the information leaflet.

Eligibility
Key inclusion criteria
Eligible participants must fulfill at least one of the following criteria:
(i) Pregnant women in the antenatal ward with a potential preterm pregnancy and their partners,
(ii) Parents whose babies are in the NICU or Special Care Nursery receiving CPAP or less.


Women aged 18 - 49 years
Men aged >18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People whose primary language is other than English (LOTE)
Children and/or young people (ie. <18 years)
People who clinicians identify as unsuitable for the study

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer program to generate random allocation to one of the 12 possible combinations of different wordings in the the three sections of the questionnaire.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The range on the adapted Porteri Score is 0-16. Assuming a mean of 10 and a standard deviation of 3, a sample of 40 patients per group in the 3 arm comparison of different wordings in Section 2 of the questionnaire yields >80% power to detect a difference of 1 Standard Deviation in the adapted Porteri Score between groups. A sample of 60 patients per group in the 2 arm comparisons of different wordings in Sections 1 and 3 of the questionnaire yields >90% power to detect a difference of 1 SD in the adapted Porteri Score between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
Date of last participant enrolment
Anticipated
21/02/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1844 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 7630 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 288407 0
University
Name [1] 288407 0
NHMRC Clinical Trials Centre, University of Sydney
Country [1] 288407 0
Australia
Funding source category [2] 288408 0
University
Name [2] 288408 0
Summer Studentship, University of Sydney
Country [2] 288408 0
Australia
Primary sponsor type
Individual
Name
Professor William Odita Tarnow-Mordi
Address
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 287106 0
Individual
Name [1] 287106 0
Dr Robert Guaran
Address [1] 287106 0
Neonatal Intensive Care Unit
Liverpool Hospital
Locked Bag 7103
Liverpool, NSW 1871
Country [1] 287106 0
Australia
Secondary sponsor category [2] 287107 0
Individual
Name [2] 287107 0
Professor Anthony Keech
Address [2] 287107 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [2] 287107 0
Australia
Secondary sponsor category [3] 287108 0
Individual
Name [3] 287108 0
Professor Alicia Jenkins
Address [3] 287108 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [3] 287108 0
Australia
Other collaborator category [1] 277718 0
Individual
Name [1] 277718 0
Dr Jacqueline Stack
Address [1] 277718 0
Neonatal Intensive Care Unit
Liverpool Hospital
Locked Bag 7103
Liverpool, NSW 1871
Country [1] 277718 0
Australia
Other collaborator category [2] 277719 0
Individual
Name [2] 277719 0
Dr Alan Adno
Address [2] 277719 0
Department of Obstetrics,
Liverpool Hospital
Locked Bag 7103
Liverpool, NSW 1871
Country [2] 277719 0
Australia
Other collaborator category [3] 277720 0
Individual
Name [3] 277720 0
Professor Phyllis Butow
Address [3] 277720 0
School of Psychology,
University of Sydney NSW 2006
Country [3] 277720 0
Australia
Other collaborator category [4] 277721 0
Individual
Name [4] 277721 0
Professor Val Gebski
Address [4] 277721 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [4] 277721 0
Australia
Other collaborator category [5] 277722 0
Individual
Name [5] 277722 0
Mrs Melinda Cruz
Address [5] 277722 0
Miracle Babies Foundation,
u5/21 Governor Macquarie Drive
Chipping Norton, NSW 2170
Country [5] 277722 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290285 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 290285 0
Research and Ethics Office
Locked Bag 7017
LIVERPOOL BC NSW 1871
Ethics committee country [1] 290285 0
Australia
Date submitted for ethics approval [1] 290285 0
28/11/2013
Approval date [1] 290285 0
Ethics approval number [1] 290285 0
AU/1/25B517

Summary
Brief summary
Few studies have investigated how to improve parents' understanding of clinical trials they are asked to join or how to reduce any possible distress. The INPUT study proposed will explore the effect of positive, negative or neutral language on parents' understanding, stress and willingness to participate in clinical trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44778 0
Prof William Odita Tarnow-Mordi
Address 44778 0
NHMRC Clinical Trials Centre,
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country 44778 0
Australia
Phone 44778 0
+61 2 9562 5000
Fax 44778 0
Email 44778 0
williamtm@med.usyd.edu.au
Contact person for public queries
Name 44779 0
Prof William Odita Tarnow-Mordi
Address 44779 0
NHMRC Clinical Trials Centre,
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country 44779 0
Australia
Phone 44779 0
+61 2 9562 5000
Fax 44779 0
Email 44779 0
williamtm@med.usyd.edu.au
Contact person for scientific queries
Name 44780 0
Prof William Odita Tarnow-Mordi
Address 44780 0
NHMRC Clinical Trials Centre,
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country 44780 0
Australia
Phone 44780 0
+61 2 9562 5000
Fax 44780 0
Email 44780 0
williamtm@med.usyd.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

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