Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000372886
Ethics application status
Approved
Date submitted
10/11/2020
Date registered
31/03/2021
Date last updated
31/03/2021
Date data sharing statement initially provided
31/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized comparison of restraint fitting education and assistance delivery methods to identify an optimum delivery method for rural and remote areas of Australia (Reach Study)
Scientific title
A randomized comparison of child car restraint fitting education and assistance delivery methods to identify an optimum delivery method for parents in rural and remote areas of Australia.
Secondary ID [1] 302444 0
GO3958 – 62
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Errors in child car restraint use. 319264 0
Condition category
Condition code
Injuries and Accidents 317231 317231 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3-arm RCT:
1) instructional online video - generic information video (how to install a child seat, how to secure the child, items to check) provided by emailed link, 10 minutes
2) in-person fitting service - delivered by qualified restraint fitter at Neighbourhood Houses in rural/remote Victoria, 20 minutes
3) fitting service delivered over remote assistance technology - delivered by qualified restraint fitter using Help Lightning interactive app (at Neighbourhood Houses to enable subsequent fitter check of installation), 20 minutes

A comprehension assessment is conducted by phone immediately following delivery of each intervention type. All three groups will receive a follow-up check at 3 months at a Neighbourhood House. The final survey will include questions on education material accessed over the 3 months. Adherence will be determined through answers to the comprehension assessment and final questionnaire.
Fidelity of the delivery of the interventions and dose delivered is relatively fixed with the number of people delivering each intervention limited and following defined procedures.
Intervention code [1] 318731 0
Prevention
Comparator / control treatment
Arm 2 is the current standard delivery method provided for child car restraint fitting.
Control group
Active

Outcomes
Primary outcome [1] 325292 0
Correct use of child car restraint, as per checklist completed by a qualified restraint fitter at Neighbourhood Houses.
Timepoint [1] 325292 0
3 months after child car restraint fitting education delivered.
Secondary outcome [1] 387431 0
Comprehension (10 item questionnaire).
The comprehension assessment is designed for this study to assess the impact of each intervention on the participants’ level of understanding of key information for ensuring correct use of child restraints. The questions are based on assessments we have used in previous work (Hall et al, 2020, 'User-driven design of child restraint information to reduce errors in use', Injury Prevention) and is based on the method described by Pander et al (2010, 'Improving the usability of patient information leaflets. Patient Educ Couns).
Timepoint [1] 387431 0
Immediately after intervention delivery.
Secondary outcome [2] 387432 0
Acceptability - qualitative semi-structured questionnaire.
Part of the follow-up survey developed for this study, the questions for acceptability were developed using a theoretical framework published by Sekhon et al (2017, ‘Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC health services research). The questions are designed to measure the seven component constructs of that theoretical framework – affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy.
Timepoint [2] 387432 0
3 months after child car restraint fitting education delivered.
Secondary outcome [3] 387433 0
Feasibility - quantitative survey.
Part of the follow-up survey developed for this study, the questions were developed to collect detail about the practical logistics/potential barriers to accessing child restraint fitting services and potential for the technology being trialled in Arm 3.
Timepoint [3] 387433 0
3 months after child car restraint fitting education delivered.

Eligibility
Key inclusion criteria
- have a child and want to use a child car seat fitting service.
- live in a rural or remote part of Victoria, and able to visit a Neighbourhood Houses location that is taking part in the study.
- own a child seat.
- speak English well enough to understand consent documents and instructions given by the fitting service.
- have a mobile phone or tablet with a camera and able to access a web browser (eg, Google Chrome, Safari).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previously use of child seat fitting service or instructional online video.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The REDCap randomisation module will be used to assign each participant from an uploaded sequence generated by an independent statistician, the sequence will not be visible to the staff using the module.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, generated by an independent statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Sample size of 112/arm to detect 20% difference between the hands-on delivery methods (2 and 3) and the online video, assuming the online video group demonstrates a similar level of correct use as the general population (50%). Calculated at 90% power at 5% significance level assuming a chi-squared test from analysis with 2 degrees of freedom, and allowing for 10% loss to follow up, we will recruit 125/arm for a total sample of 375.

Sample characteristics will be described as percentages for categorical variables, or range, mean, 95% CI and SD for continuous variables.
For primary analyses, we will use the chi-square test to compare proportions of serious misuse between the three groups. For secondary analysis, differences in mean percent comprehension scores between groups will be assessed using one-way ANOVA.
Qualitative methods will be used to examine acceptability in line with the theoretical framework for acceptability and emerging themes related to feasibility. Qualitative analyses will be within-group analyses, with a mixed method approach to between group analyses. We will also explore the relationship between % correct use and % comprehension using appropriate regression models.

A participant follow-up survey designed for this study will collect additional information on potential confounders of the outcome measure. Questions were drawn from previous studies where we have used a similar outcome measure (e.g. Brown et al, 2020 'A process evaluation protocol for examining the impact of instruction for correct use of child car seats designed through a consumer-driven process and evaluation in a field-based randomised controlled trial', Int J Env Res & Public Health, & Brown et al, 2019 'Can child restraint product information developed using consumer testing sustain correct use 6 months after child restraint purchase? Study protocol for a cluster randomised controlled trial', Injury Prevention).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/04/2021
Actual
Date of last participant enrolment
Anticipated
30/07/2021
Actual
Date of last data collection
Anticipated
29/10/2021
Actual
Sample size
Target
375
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306870 0
Government body
Name [1] 306870 0
Dept. of Infrastructure, Transport, Regional Development and Communications
Country [1] 306870 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
PO Box M201, Missenden Road NSW 2050
Country
Australia
Secondary sponsor category [1] 307427 0
None
Name [1] 307427 0
Address [1] 307427 0
Country [1] 307427 0
Other collaborator category [1] 281498 0
Charities/Societies/Foundations
Name [1] 281498 0
Kidsafe Victoria
Address [1] 281498 0
Monash Children’s Hospital
Dixon Street, Clayton VIC 3168
Country [1] 281498 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307025 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 307025 0
Ethics committee country [1] 307025 0
Australia
Date submitted for ethics approval [1] 307025 0
22/09/2020
Approval date [1] 307025 0
14/12/2020
Ethics approval number [1] 307025 0
HC200764

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

Contacts
Principal investigator
Name 105782 0
A/Prof Julie Brown
Address 105782 0
The George Institute for Global Health
PO Box M201, Missenden Road, NSW 2050
Country 105782 0
Australia
Phone 105782 0
+61 2 8052 4420
Fax 105782 0
Email 105782 0
[email protected]
Contact person for public queries
Name 105783 0
Kirsten Jakobsen
Address 105783 0
The George Institute for Global Health
PO Box M201, Missenden Road, NSW 2050
Country 105783 0
Australia
Phone 105783 0
+61 2 8052 4379
Fax 105783 0
Email 105783 0
[email protected]
Contact person for scientific queries
Name 105784 0
Julie Brown
Address 105784 0
The George Institute for Global Health
PO Box M201, Missenden Road, NSW 2050
Country 105784 0
Australia
Phone 105784 0
+61 2 8052 4420
Fax 105784 0
Email 105784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not intended at this stage.


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.