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Trial registered on ANZCTR


Registration number
ACTRN12623000886684
Ethics application status
Approved
Date submitted
28/03/2023
Date registered
18/08/2023
Date last updated
14/07/2024
Date data sharing statement initially provided
18/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Provision of an information video prior to an infant’s diagnostic audiology assessment.
Scientific title
The effect of provision of an information video prior to an infant’s diagnostic audiology assessment on parents' knowledge and anxiety.
Secondary ID [1] 308827 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant hearing 328786 0
Condition category
Condition code
Ear 325796 325796 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Victorian Infant Hearing Screening Program (VIHSP) is a state-wide program that screens the hearing of newborn babies in their first few weeks of life. Approximately 0.8% of infants receive a positive (‘refer’) result on their hearing screen and are referred to one of 13 Victorian diagnostic audiology clinics for further assessment of their hearing.
The intervention used in this study is an information video resource developed by VIHSP. The information video follows a mother and her infant as they attended the infant’s initial diagnostic audiology appointment. The information video was designed to help prepare parents for their infant's diagnostic audiology appointment. This information video is approximately six-minutes in length and provides the viewer with both visual and auditory information about the audiology equipment, the likely sequence of events, the purpose of each test, and how best to prepare their infant for the appointment. All parents/caregivers whose baby is referred to audiology have preparatory information provided by VIHSP and the diagnostic audiology centre as part of usual care. The information video will be provided to parent/caregivers allocated to the intervention group, in addition to the resources provided as part of usual care. The information video will be provided prior to the infant diagnostic audiology appointment. It will be provided to parents/caregivers within the single time-point online study survey. Completing the online survey involves watching the six-minute information video (for those in the intervention group) and answering a series of questions, including demographic, knowledge about the diagnostic audiology appointment, feelings about the diagnostic audiology appointment and answering items from a standardised anxiety measure. For the intervention group, participants complete the demographic questions first, watch the information video, then answer all other questions. Participants in the intervention group will also answer specific questions about the usefulness of the video and whether they would recommend it to others. Analysis of the survey data will be used to describe parent/caregivers’ perception of the video, feedback about the video and impact of the video on knowledge an anxiety. The period of intervention (and data collection) lies between referral to audiology and the appointment date (median 13 days).
Intervention code [1] 325275 0
Behaviour
Comparator / control treatment
All parents/caregivers whose baby is referred by VIHSP to diagnostic audiology within the study period will be invited into the study. All participants will receive usual care. The control group will receive usual care. As part of usual care parent/caregivers are contacted by a dedicated VIHSP Early Support Service (ESS) facilitator (case-facilitator) following their infants' referral to diagnostic audiology. The ESS facilitator is available to support each family prior to the diagnostic audiology appointment right up to enrolment into early intervention (for those diagnosed with moderate-profound hearing loss). ESS is available to be contacted by parent/caregivers at any time in the diagnostic and intervention pathway, meaning that component of usual care is available to parents while they are participants in the study. The amount of ESS engagement with each family is dependent on the family’s wishes and needs. On average, ESS has 1.1 hours of engagement with each family.
As part of usual care ESS provide parents with preparatory written/verbal information about the diagnostic audiology appointment. Audiology centres may also provide parents written/verbal information. The specific information and medium will depend on the individual diagnostic audiology centre.
Control group
Active

Outcomes
Primary outcome [1] 333642 0
Knowledge about the infant diagnostic audiology appointment assessed using the study designed knowledge questions
Timepoint [1] 333642 0
Single survey timepoint - post randomisation (and prior to attendance at the diagnostic audiology appointment).
Secondary outcome [1] 417845 0
Anxiety assessed using the State Trait Anxiety Inventory for Adults - Short Form
Timepoint [1] 417845 0
Single survey timepoint - post randomisation (and prior to attendance at the diagnostic audiology appointment).
Secondary outcome [2] 417846 0
The number of infant diagnostic audiology appointments required to reach a complete audiology diagnosis as assessed by the number of audiology appointment attended to confirm the infant's level of hearing.
Timepoint [2] 417846 0
Following completion of the diagnostic audiology assessment (data extracted from the VIHSP clinical database at data analysis).

Eligibility
Key inclusion criteria
Parents/caregivers who have:
• an infant who received a referral (screen refer or direct refer) to audiology from VIHSP during the study recruitment period
• the capacity to provide informed consent to participate
• internet access and the capacity (via a device and valid email address) to receive study documents electronically and complete study activities online
• sufficient English that they can complete the study documents and activities adequately without the use of an interpreter.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents/caregivers
• whose infant is medically unstable or being palliated
• whose infant is in ‘out of home care’
• who are unable to complete the study documents and activities due to their English language level
• who exhibit a level of distress whereby VIHSP staff consider an invitation to participate in the study to be detrimental to their wellbeing.

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)
This study will use allocation concealment. Randomisation syntax will be written into REDCap (online survey and data management tool), to allow randomisation to occur automatically within REDCap when triggered by the consent question within the study survey. Therefore, VIHSP staff who invite parents/caregivers to participate in this study will not know which group the parent/caregiver will be allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study statistician will prepare syntax for REDCap using 1:1 ratio and block randomisation with variable block sizes of 2 and 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this study is calculated based on the STAI Adult Short Form to measure anxiety. This questionnaire has well documented psychometric properties. It is anticipated that a sample sized calculated for the STAI will be adequate for the knowledge questionnaire also. For the sample size calculation, a difference in mean score between the groups of 2.5 was chosen as clinically important, a standard deviation of 6.8 was used, alpha was set to 0.05 and power set to 80%. The power command in the statistical software Stata 16.1 was used to generate the sample size. The total number of participants required is 236 (118 per group). Assuming 75% agree to participate, approximately 315 participants will need to be approached. Based on the average rate of referrals, 45 referrals per month, we expect recruitment will take seven to ten months. Recruitment will continue until the desired number of participants have been recruited. Please note data completed/submitted after the diagnostic audiology appointment cannot be included in analysis (a diagnosis is likely to impact the outcomes measures). Data collection and timing will be continuously monitored to ensure recruitment continues until the desired sample size for data analysis is met.

Both the control group and the intervention group will be compared in relation to their status on potential confounding variables. A multilevel mixed effect model will be used to determine the intervention effect, addressing study aims. A multilevel mixed effect model offers the following advantages for this study design:
• account for the non-independence in the data, which in this study is case-paired data on individuals
• enable use of all data available

As Knowledge Score (Aim 1) is a continuous measure a linear mixed model will be fitted to determine the mean difference between groups.
As Anxiety Score (Aim 2) is a continuous outcome, a linear mixed model will be fitted to estimate the mean difference.
For Aim 3 - the intervention effect will be estimated by the difference of means for number of appointments required to reach a final diagnosis, with a 95% CI. The hypothesis of no difference between means will be tested using t-test. If the mean is not considered the appropriate summary measure, the median of each group will be reported. The hypothesis of no difference in medians will be tested using the medians test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/02/2024
Actual
15/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
315
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23881 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 39346 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 313053 0
Other
Name [1] 313053 0
Victorian Infant Hearing Screening Program
Country [1] 313053 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital
Address
50 Flemington Road, Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 314739 0
None
Name [1] 314739 0
Address [1] 314739 0
Country [1] 314739 0
Other collaborator category [1] 282532 0
Other
Name [1] 282532 0
Murdoch Children's Research Institute
Address [1] 282532 0
50 Flemington Road, Parkville, Victoria, 3052
Country [1] 282532 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312305 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 312305 0
Ethics committee country [1] 312305 0
Australia
Date submitted for ethics approval [1] 312305 0
22/11/2022
Approval date [1] 312305 0
13/01/2023
Ethics approval number [1] 312305 0

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

Contacts
Principal investigator
Name 124178 0
Ms Alison Jagger
Address 124178 0
Centre for Community Child Health
The Royal Children's Hospital, Melbourne
50 Flemington Road, Parkville, Vic 3052
Country 124178 0
Australia
Phone 124178 0
+61 3 9345 4941
Fax 124178 0
+61 3 9345 5049
Email 124178 0
alison.jagger@rch.org.au
Contact person for public queries
Name 124179 0
Alison Jagger
Address 124179 0
Centre for Community Child Health
The Royal Children's Hospital, Melbourne
50 Flemington Road, Parkville, Vic 3052
Country 124179 0
Australia
Phone 124179 0
+61 3 9345 4941
Fax 124179 0
+61 3 9345 5049
Email 124179 0
alison.jagger@rch.org.au
Contact person for scientific queries
Name 124180 0
Alison Jagger
Address 124180 0
Centre for Community Child Health
The Royal Children's Hospital, Melbourne
50 Flemington Road, Parkville, Vic 3052
Country 124180 0
Australia
Phone 124180 0
+61 3 9345 4941
Fax 124180 0
+61 3 9345 5049
Email 124180 0
alison.jagger@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is not collecting participant consent for this level of data sharing. Deidentified aggregate data will be available. Request for access to deidentified aggregate data will be considered on a case-by-case basis. Data will only be made available at completion of the study and following publication of results and for up to 5 years post publication. Requests can be made by contacting the VIHSP Directors, who act as custodians of the data. The VIHSP Directors can be contacted at email.vihsp@rch.org.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18693Study protocol  email.vihsp@rch.org.au Please contact the VIHSP Directors, to request a c... [More Details]
18694Statistical analysis plan  email.vihsp@rch.org.au Please contact the VIHSP Directors, to request a c... [More Details]
18695Ethical approval  email.vihsp@rch.org.au Please contact the VIHSP Directors to request a co... [More Details]



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.