Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001431314
Ethics application status
Approved
Date submitted
3/10/2017
Date registered
9/10/2017
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Date results information initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
"A glint or a squint should make you think." Determining the impact of an eye-health awareness pamphlet for parents.
Scientific title
"A glint or a squint should make you think" A randomised controlled study to determine the impact of an eye-health awareness pamphlet for parents.
Secondary ID [1] 291649 0
None
Universal Trial Number (UTN)
U111-1203-0485
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
strabismus 302800 0
leukocoria 302801 0
Condition category
Condition code
Eye 302297 302297 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Principal Investigator developed the pamphlet two phases.
Phase 1:
An exploratory qualitative study to identify knowledge gaps and determine factors that influence parents’ help-seeking intentions for ocular symptoms in young children was undertaken. With Human Research Ethics Approval, 18 parents participated in 5 focus groups using photographic prompts of different eye diseases/problems in children. These included: conjunctivitis, swollen eye, white pupil [leukocoria] and turned/crossed-eye [strabismus].

Using an inductive thematic analysis approach [Braun & Clarke, 2006], data from the focus groups were then analysed to inform and guide the content of the paediatric eye-health awareness pamphlet for parents. The development of this pamphlet was grounded in an evidence-based approach to develop health promotion materials - ‘Information-Motivation-Behavioural skills’ (IMB) model. {Abraham & Kools, 2012] This theoretical framework specifies that effective health promotion material needs to: address information gaps [information]; provide arguments that motivate behaviour [motivation]; and provide instruction and explanation to perform behaviour [behaviour skills]. Key messages included in the pamphlet addressed the deficits in their knowledge that were identified, messages to motivate action and messages to inform behavioural skills to bring about a change in behaviour.

Phase 2:
Seventeen cognitive interviews were conducted with women who were either pregnant, had children or were of child-bearing age to review the pamphlet and provide feedback on content, design, layout and comprehension. Following this process, the pamphlet was modified accordingly.

The intervention is provided once only for participants randomised to the intervention group at Baseline. Following un-blinding at the conclusion of the study, participants allocated to the control group at Baseline will be provided with the pamphlet to maintain clinical equipoise.
Intervention code [1] 297733 0
Early detection / Screening
Intervention code [2] 299300 0
Behaviour
Comparator / control treatment
The control treatment is a very brief information pamphlet which provides information to the participant about playing with a baby. There is no content referring to signs of paediatric eye disease. This pamphlet is currently available to parents via the Department of Education and Training Maternal and Child Health Information website and is provided to all parents when their child is born.
Control group
Active

Outcomes
Primary outcome [1] 301761 0
Knowledge of leukocoria

A survey has been specifically designed for the purpose of this RCT.
Single item True/False questions and clinical scenarios with photographic prompts with Likert scale items will assess the participants' knowledge of signs of leukocoria.
Timepoint [1] 301761 0
2 weeks post-intervention
Primary outcome [2] 303578 0
Knowledge of strabismus

A survey has been specifically designed for the purpose of this RCT.
Single item True/False questions and clinical scenarios with photographic prompts with Likert scale items will assess the participants' knowledge of signs of leukocoria.
Timepoint [2] 303578 0
2 weeks post-intervention
Secondary outcome [1] 333792 0
Parents' help-seeking intentions if signs of strabismus or leukocoria are observed in their child.

A survey has been specifically designed for the purpose of this RCT.
Single item True/False questions and clinical scenarios with photographic prompts with Likert scale items will assess the participants' perceived urgency and help-seeking intentions if these ocular signs were observed.
Timepoint [1] 333792 0
2 weeks post-intervention

Eligibility
Key inclusion criteria
Pregnant women in 2nd or 3rd trimester of pregnancy
English-speaking
Regular access to email for completion of post-test survey
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cognitive impairment precluding consent to participate for self
Non-English speaking
No regular access to email for completion of post-test survey

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Randomisation will be stratified by whether the participant 1) does or 2) does not have other children
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be performed on an “intention-to-treat” method i.e. regardless of whether those in the intervention group read the leaflet or not. Response of the two groups of parents (intervention and control) will be compared initially using non-parametric tests given the ordinal nature of the data (such as Mann-Whitney test). Rasch analysis will be performed on appropriate outcome assessment to ensure that study-specific assessment tools are psychometrically sound. Confounding variables such as age, English as a second language and educational status will be explored and adjusted for, as appropriate in multiple logistic regression analysis. Additionally, all available participant information will be used to screen for factors that could moderate the outcome of the intervention i.e. does the intervention only have an effect in those with higher levels of education?

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/02/2018
Actual
8/03/2018
Date of last participant enrolment
Anticipated
29/06/2018
Actual
29/05/2018
Date of last data collection
Anticipated
13/07/2018
Actual
25/06/2018
Sample size
Target
520
Accrual to date
Final
518
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9153 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 17666 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 296147 0
Government body
Name [1] 296147 0
NHMRC Post-graduate Scholarship
Country [1] 296147 0
Australia
Primary sponsor type
Other
Name
Centre for Eye Research Australia
Address
Level 7, Peter Howson Wing
32 Gisborne Street
East Melbourne, 3002
VICTORIA
Country
Australia
Secondary sponsor category [1] 296690 0
None
Name [1] 296690 0
Address [1] 296690 0
Country [1] 296690 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297394 0
Human Research Ethics Committee - Royal Women's Hospital
Ethics committee address [1] 297394 0
The Royal Women's Hospital - HREC
Locked Bag 300
Grattan St & Flemington Rd
Parkville VIC 3052 AUSTRALIA
Ethics committee country [1] 297394 0
Australia
Date submitted for ethics approval [1] 297394 0
01/11/2017
Approval date [1] 297394 0
20/12/2017
Ethics approval number [1] 297394 0
17-38

Summary
Brief summary
Retinoblastoma is the most commonly occurring paediatric eye cancer. The earliest signs of disease include leukocoria (white pupil) and strabismus (crossed eye). Untreated, retinoblastoma results in loss of sight, eye or life. Common strabismus occurs in up to 2-4% of children resulting in poor vision when diagnosed and treated late. Unfortunately, white pupil or strabismus are often ignored as there is a lack of information and misinformation regarding the importance of these signs.
Currently, no systematic information is provided to parents in Victoria regarding leukocoria or strabismus. Raising parental awareness of these signs could reduce delays in diagnosis and result in earlier treatment with the potential for improved outcomes.
This randomized controlled trial aims to evaluate an evidence-based, theory-informed information pamphlet that has been developed for parents. It is hypothesized that parents who receive the pamphlet would be more alert to these early signs and have heightened help-seeking intentions.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2596 2596 0 0
/AnzctrAttachments/372713-signed approval RWH.pdf (Ethics approval)
Attachments [2] 2597 2597 0 0
/AnzctrAttachments/372713-Appendix A_Glint-or-Squint_Research Protocol_v2_27Nov17.docx (Protocol)
Attachments [3] 2598 2598 0 0
/AnzctrAttachments/372713-Appendix G_PICF_RCT_v3_19Dec17_clean.docx (Participant information/consent)

Contacts
Principal investigator
Name 73910 0
Dr Sandra Staffieri
Address 73910 0
Centre for Eye Research Australia
Level 7, Peter Howson Wing
32 Gisborne Street
East Melbourne, VICTORIA 3002
Country 73910 0
Australia
Phone 73910 0
+61 3 99298713
Fax 73910 0
Email 73910 0
[email protected]
Contact person for public queries
Name 73911 0
Dr Sandra Staffieri
Address 73911 0
Centre for Eye Research Australia
Level 7, Peter Howson Wing
32 Gisborne Street
East Melbourne, VICTORIA 3002
Country 73911 0
Australia
Phone 73911 0
+61 3 99298713
Fax 73911 0
Email 73911 0
[email protected]
Contact person for scientific queries
Name 73912 0
Prof Alex Hewitt
Address 73912 0
Centre for Eye Research Australia
Level 7, Peter Howson Wing
32 Gisborne Street
East Melbourne, VICTORIA 3002
Country 73912 0
Australia
Phone 73912 0
+61 3 99298713
Fax 73912 0
Email 73912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pre- and post-test survey data
When will data be available (start and end dates)?
Data will be available from 1/1/2021 with no end date.
Available to whom?
The data will be made available to researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of the Principal Investigator
Available for what types of analyses?
Data will be made available to achieve the aims in an ethically approved research proposal or to contribute to an IPD meta-analysis
How or where can data be obtained?
Data can be obtained from the Principal Investigator by email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7522Study protocol  [email protected]
7523Statistical analysis plan  [email protected]
7524Informed consent form  [email protected]
7525Clinical study report  [email protected]
7526Ethical approval  [email protected]
7527Analytic code  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 372713-(Uploaded-20-03-2020-10-52-06)-Basic results summary.pdf
Plain language summaryNo Background: Primary caregivers are usually the fir... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving parents' knowledge of early signs of paediatric eye disease: A double-blind randomized controlled trial.2020https://dx.doi.org/10.1111/ceo.13866
N.B. These documents automatically identified may not have been verified by the study sponsor.