Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001337763
Ethics application status
Not yet submitted
Date submitted
6/12/2013
Date registered
6/12/2013
Date last updated
19/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Public Awareness of Clinical Trials through Online Questionnaires: the IMPACT online study
Scientific title
Improving Public Awareness of Clinical Trials through Online Questionnaires: the IMPACT online study
Secondary ID [1] 283608 0
Nil known
Universal Trial Number (UTN)
U1111-1150-4192
Trial acronym
IMPACT Online Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Understanding of clinical trials 290529 0
Anxiety about clinical trials 290530 0
Willingness to participate in clinical trials 290531 0
Condition category
Condition code
Public Health 290930 290930 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study in split into two components: Survey A and B. Respondents who agree to participate will be randomly assigned to either Survey A or B, and undergo one survey only. The study will be administered online. In Survey A, respondents will be randomly assigned to read one of 12 (2x3x2) variations of a leaflet describing a hypothetical trial. These variations incorporate positive, negative or neutral wording. The leaflet is based on BOOST II (www.nejm.org/doi/full/10.1056/NEJMoa1302298). In Survey B, respondents will be randomly presented either (i) a video describing features of clinical trials (ii) a written transcript of the video or (iii) no information. The approximate duration of the video is 5 minutes.
Intervention code [1] 288301 0
Behaviour
Comparator / control treatment
Providing no information about clinical trials
Control group
Active

Outcomes
Primary outcome [1] 290912 0
For Survey A, the primary outcome being observed is the parent's level of understanding. This will be measured using a previously validated questionnaire (Porteri et al, 2009) adapted for use in parents of newborn infants.
Timepoint [1] 290912 0
During completion of the anonymous online survey
Primary outcome [2] 291036 0
For Survey B, respondents’ level of understanding will be measured on a three part Likert Scale on the key aspects and common pitfalls of randomized clinical trials.
Timepoint [2] 291036 0
During completion of the anonymous online survey
Secondary outcome [1] 305589 0
Both Survey A and B measure general anxiety and changes in levels of anxiety after receiving the intervention. For Survey A this is one of 12 variations of the BOOST II leaflet; and for Survey B this is either the video or the transcript of the ECRAN Video Introduction to Clinical Trials or the control, summing to 3 variations.

Anxiety will be measured using the previously validated State-Trait Anxiety Inventory Form Y (Spielberger et al, 1977; O’Brien et al, 2013).
Timepoint [1] 305589 0
During completion of the anonymous online survey
Secondary outcome [2] 305590 0
The secondary outcome for both Survey A and B, parents’ willingness to participate, will be measured on a five part Likert Scale ranging from very unlikely to very likely to participate.
Timepoint [2] 305590 0
During completion of the anonymous online survey

Eligibility
Key inclusion criteria
Agreement to complete anonymous online questionnaire
Reported age 18 years or older
Parents
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non agreement to complete anonymous online questionnaire
Reported age less than 18 years

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)
Potential participants will be invited to consider contributing to the study via the Facebook pages of Miracle Babies Foundation and other similar parent support organisations in other countries.

After accessing the anonymous online questionnaire and agreeing to participate participants will be randomly allocated to Survey A or to Survey B, without prior knowledge of which survey will be allocated. This will be done via central randomisation by computer.

In Survey A participants will be randomly allocated to
read 1 of 12 versions of a hypothetical information leaflet describing a hypothetical a randomised controlled trial in preterm babies, without prior knowledge of which intervention will be allocated. This will be done via central randomisation by computer.

In Survey B participants will be randomly allocated to (a) watch a 5 minute video describing features of randomised clinical trials (b) read a transcript of the 5 minute video (c) receive no information about clinical trials, without prior knowledge of which intervention will be allocated. This will be done via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Survey A is a randomised 2x3x2 factorial comparison of (i) negative versus positive language, or (ii) neutral versus negative versus positive language or (iii) negative versus postiive language in 3 sections of the leaflet.
Survey B is a 3 arm randomised controlled trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In these anonymous surveys no prior data exist to provide robust estimates of background rates of understanding, anxiety or willingness to participate in clinical trials in the population of those accessing the Facebook pages of Miracle Babies Foundation, or others who may access the links to the study.

However, assuming the score to measure understanding of clinical trials (Primary Outcome) behaves as a continuous variable from 0-22 with a standard deviation of 3, about 50 respondents per group are needed to yield over 80% to show a difference of 3 score units between groups with two sided statistical significance of p=0.05. Therefore at least 150 respondents will be sought for each Survey.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/12/2013
Actual
Date of last participant enrolment
Anticipated
21/02/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 5635 0
United Kingdom
State/province [1] 5635 0
Country [2] 5636 0
New Zealand
State/province [2] 5636 0
Country [3] 5637 0
Jamaica
State/province [3] 5637 0
Country [4] 5638 0
United States of America
State/province [4] 5638 0
Country [5] 5639 0
Ireland
State/province [5] 5639 0
Country [6] 5640 0
South Africa
State/province [6] 5640 0

Funding & Sponsors
Funding source category [1] 288290 0
University
Name [1] 288290 0
NHMRC Clinical Trials Centre, University of Sydney
Country [1] 288290 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
WINNER Centre for Newborn Research, NHMRC Clinical Trials Centre, Locked Bag 77, Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 287011 0
Charities/Societies/Foundations
Name [1] 287011 0
Miracle Babies Foundation
Address [1] 287011 0
u6/21 Governor MacQuarie Drive
Chipping Norton
Sydney
New South Wales 2170
Country [1] 287011 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290185 0
University of Sydney Human Research Ethics Committee 1
Ethics committee address [1] 290185 0
Ethics committee country [1] 290185 0
Australia
Date submitted for ethics approval [1] 290185 0
18/11/2013
Approval date [1] 290185 0
Ethics approval number [1] 290185 0

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

Contacts
Principal investigator
Name 44390 0
Prof William Tarnow-Mordi
Address 44390 0
WINNER Centre for Newborn Research
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
NSW 1450
Country 44390 0
Australia
Phone 44390 0
612 9562 5000
Fax 44390 0
Email 44390 0
williamtm@med.usyd.edu.au
Contact person for public queries
Name 44391 0
Melinda Cruz
Address 44391 0
Miracle Babies Foundation
u6/21 Governor MacQuarie Drive
Chipping Norton
Sydney
NSW 2170
Country 44391 0
Australia
Phone 44391 0
612 9724 8999
Fax 44391 0
Email 44391 0
melinda.cruz@miraclebabies.org.au
Contact person for scientific queries
Name 44392 0
William Tarnow-Mordi
Address 44392 0
WINNER Centre for Newborn Research
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country 44392 0
Australia
Phone 44392 0
612 9562 5000
Fax 44392 0
Email 44392 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

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

Documents added automatically
No additional documents have been identified.