ANZCTR - Registration

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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 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]

None

Universal Trial Number (UTN)

U111-1203-0485

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

strabismus

leukocoria

Condition category

Condition code

Eye

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]

Early detection / Screening

Intervention code [2]

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]

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]

2 weeks post-intervention

Primary outcome [2]

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]

2 weeks post-intervention

Secondary outcome [1]

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]

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]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Post-graduate Scholarship

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee - Royal Women's Hospital

Ethics committee address [1]

The Royal Women's Hospital - HREC
Locked Bag 300
Grattan St & Flemington Rd
Parkville VIC 3052 AUSTRALIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2017

Approval date [1]

20/12/2017

Ethics approval number [1]

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]

/AnzctrAttachments/372713-signed approval RWH.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/372713-Appendix A_Glint-or-Squint_Research Protocol_v2_27Nov17.docx (Protocol)

Attachments [3]

/AnzctrAttachments/372713-Appendix G_PICF_RCT_v3_19Dec17_clean.docx (Participant information/consent)

Contacts

Principal investigator

Name

Dr Sandra Staffieri

Address

Centre for Eye Research Australia
Level 7, Peter Howson Wing
32 Gisborne Street
East Melbourne, VICTORIA 3002

Country

Australia

Phone

+61 3 99298713

Fax

sandra.staffieri@unimelb.edu.au

Contact person for public queries

Name

Sandra Staffieri

Address

Centre for Eye Research Australia
Level 7, Peter Howson Wing
32 Gisborne Street
East Melbourne, VICTORIA 3002

Country

Australia

Phone

+61 3 99298713

Fax

sandra.staffieri@unimelb.edu.au

Contact person for scientific queries

Name

Alex Hewitt

Address

Centre for Eye Research Australia
Level 7, Peter Howson Wing
32 Gisborne Street
East Melbourne, VICTORIA 3002

Country

Australia

Phone

+61 3 99298713

Fax

hewitt.alex@gmail.com

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: sandra.staffieri@unimelb.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Email
7522	Study protocol	sandra.staffieri@unimelb.edu.au
7523	Statistical analysis plan	sandra.staffieri@unimelb.edu.au
7524	Informed consent form	sandra.staffieri@unimelb.edu.au
7525	Clinical study report	sandra.staffieri@unimelb.edu.au
7526	Ethical approval	sandra.staffieri@unimelb.edu.au
7527	Analytic code	sandra.staffieri@unimelb.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Improving parents' knowledge of early signs of paediatric eye disease: A double-blind randomized controlled trial.	2020	https://dx.doi.org/10.1111/ceo.13866

N.B. These documents automatically identified may not have been verified by the study sponsor.

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