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Trial registered on ANZCTR


Registration number
ACTRN12622000546752
Ethics application status
Approved
Date submitted
10/11/2021
Date registered
7/04/2022
Date last updated
8/03/2023
Date data sharing statement initially provided
7/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Perth Children's Hospital (PCH) Healthy Ears: A telehealth-facilitated randomised-controlled trial utilising a health promotion intervention to resolve otitis media with effusion for children on specialist Ear, Nose and Throat (ENT) waiting lists.
Scientific title
Healthy Ears: A telehealth-facilitated randomised-controlled trial utilising a health promotion intervention to resolve otitis media with effusion for children on specialist Ear, Nose and Throat (ENT) waiting lists.
Secondary ID [1] 305767 0
None
Universal Trial Number (UTN)
Trial acronym
PCH Healthy Ears
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Media with Effusion 324275 0
Condition category
Condition code
Ear 321768 321768 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children and their guardian(s) will be randomly allocated to undertake one of two different ear health promotion programs. The guardian(s) will be asked to complete the allocated health promotion program with their child twice daily for one month. Children will be provided with age appropriate stickers to add to a diary each time the ear health promotion program is performed. Adherence to the health promotion program will be supported by a REDCap survey distributed weekly throughout the duration of the period of the intervention or control, prompting guardian(s) to enter an approximate amount of times their child completed the ear health promotion program during that week in numerical form.

In addition to the ear health promotion program, participants will receive watchful waiting for their OME. This encompasses the participant receiving ear and hearing health assessments at regular and pro re nata intervals and the subsequent escalation of care as clinically indicated whilst awaiting ENT review and/or surgical intervention. Participants will also receive supportive care for their OME. This involves encouraging and empowering guardian(s) to contact the research team (via phone or email) at any point throughout the study to voice any questions or concerns they may have about their child’s ear health and organise to arrange an unscheduled study visit for the participant if requested and/or deemed clinically appropriate. Participants will also be provided with generic ear health resources, including an information sheet published by the Child and Adolescent Health Service (CAHS) on OME (or 'glue ear').
Intervention code [1] 322168 0
Treatment: Other
Comparator / control treatment
Children and their guardian(s) will be randomly allocated to undertake one of two different ear health promotion programs. The guardian(s) will be asked to complete the allocated health promotion program with their child twice daily for one month. Children will be provided with age appropriate stickers to add to a diary each time the ear health promotion program is performed. Adherence to the health promotion program will be supported by a REDCap survey distributed weekly throughout the duration of the period of the intervention or control, prompting guardian(s) to enter an approximate amount of times their child completed the ear health promotion program during that week in numerical form.

In addition to the ear health promotion program, participants will receive watchful waiting for their OME. This encompasses the participant receiving ear and hearing health assessments at regular and pro re nata intervals and the subsequent escalation of care as clinically indicated whilst awaiting ENT review and/or surgical intervention. Participants will also receive supportive care for their OME. This involves encouraging and empowering guardian(s) to contact the research team (via phone or email) at any point throughout the study to voice any questions or concerns they may have about their child’s ear health and organise to arrange an unscheduled study visit for the participant if requested and/or deemed clinically appropriate. Participants will also be provided with generic ear health resources, including an information sheet published by the Child and Adolescent Health Service (CAHS) on OME (or 'glue ear').
Control group
Active

Outcomes
Primary outcome [1] 329517 0
The proportion of non-surgical resolution of OME, evidenced by type A or type C tympanograms, in the intervention group compared to the control group.
Timepoint [1] 329517 0
Baseline at week 0
week 4-6 post-randomisation (primary endpoint)
week 24-32 post-randomisation
Secondary outcome [1] 402839 0
The proportion of discharges from the PCH ENT outpatient scheduling list and surgical list in the intervention group compared to the control group.
Timepoint [1] 402839 0
Baseline at week 0
week 4-6 post randomisation
week 24-32 post randomisation
Secondary outcome [2] 402840 0
The four-frequency average hearing thresholds measured by audiometry in the intervention group compared to the control group.
Timepoint [2] 402840 0
Baseline at week 0
week 4-6 post randomisation
week 24-32 post randomisation
Secondary outcome [3] 402841 0
Quality of life assessed using the OM-6, PLUM and HATS outcome measures in the intervention group compared to the control group. This outcome will be a composite outcome as it will be determined using a combination of the above outcome measures.
Timepoint [3] 402841 0
Baseline at week 0
week 4-6 post randomisation
week 24-32 post randomisation
Secondary outcome [4] 402842 0
Comparison of cost-of-service for OME diagnosis and management through the PCH Ear Health Promotion trial (conducted via the PCH Ear Portal pathway) compared to standard care.

The units of measure are:
i) cost for confirmed diagnosis of persistent OME in $AUD per patient or per patient presenting with OME.
ii) treatment costs of OME measured in $AUD and calculated based on the number of children requiring ventilation tube insertion (VTI) surgery in each group.
iii) benefit in terms of number of children in both groups experiencing resolution of OME post-referral to PCH, whether spontaneous or related to the ear health promotion intervention.

This outcome will be a composite outcome as it will be determined using a combination of the above outcome measures.
Timepoint [4] 402842 0
Annually or at end of the study
Secondary outcome [5] 402843 0
The bacterial load in the intervention group compared to the control group by the count of colonies in the culture of the hand and nasopharyngeal swabs as a composite secondary outcome.
Timepoint [5] 402843 0
Baseline at week 0
week 4-6 post-randomisation
Secondary outcome [6] 402844 0
The proportion of adverse events in the intervention group compared to the control group. This will be analysed based upon the number of and nature of adverse events reported by participants and research staff according to the National Health and Medical Research Council (NHMRC) 2018 guideline “Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods".
Timepoint [6] 402844 0
week 4-6 post-randomisation
week 24-32 post-randomisation

Eligibility
Key inclusion criteria
1. Children aged between three years old and seven years old.
2. Children identified during the triage of initial referral to PCH for hearing or ear-related presenting complaints.
3. Children who have the capacity to comply with study procedures, including follow up, regardless of residential geographical location.
4. Children who have been assessed and subsequently confirmed persistent otitis media with effusion (greater than or equal to 3 months) within a twelve month period as well as the following clinical criteria:
a) Type B tympanometry,
i. Unilateral or bilateral
ii. With or without hearing loss.
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children who are known to be scheduled to undergo surgical intervention within four weeks.
2. Children who have been diagnosed with any of the following complex medical conditions which increases the risk of complications; cleft lip and palate, Down syndrome, major chromosomal anomalies, craniofacial anomalies, chronic suppurative otitis media, or congenital ear anomalies.
3. Children who are actively participating in another ear intervention study.
4. Children are unable to comply with relevant study procedures due to any physical, medical, developmental, behavioural or cognitive condition.
5. Guardian(s) decline to cease the use of ear clearing devices for the four-to-six-week duration of the intervention and control, ie. ear syringe, ear candle, ear relief device (EarPopper®), over-the-counter ear drops, nasal balloon etc.
6. The child’s legal representative is unwilling or unable to provide informed consent for the minor to participate in the study.
7. The child does not meet the clinical inclusion criteria..

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained during the study by having two separate project members. One project member will determine a participant's eligibility for the trial. Once a participants eligibility is confirmed, this project member will refer the participant on to a second project member who will be responsible for the enrolment and randomisation of the participant into either the control or intervention arm of the study. This will ensure the first project member will remain unaware of the allocations of all participants throughout the trial.

Once the second project member has completed the randomised allocation, they will provide the relevant instruction and advice to participants and their guardian(s) on how to perform the ear health promotion program they are allocated. All study materials will be provided to participants in sealed opaque envelopes, and participant's and their guardian's will be asked not to bring any of their study materials with them to study appointments that are conducted by project members whom are unaware of a participant's allocation. All participant enquiries about the study materials provided will be directed to the project member who is the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children will be randomised into the intervention or the control group using the randomisation module built into the REDCap database established for the trial. The randomisation of participants will be stratified according to recruitment pathway (surgical list or outpatient list/Ear Portal pathways), unilateral or bilateral OME and previous VTI surgery.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Power calculations performed by trial simulation and assuming a moderate 13% increase in OME resolution after four-to-six weeks in the intervention arm compared to control arms, estimate the power to be ~80% and type 1 error rate to be 5% for a maximum sample size of 250 participants. Accounting for a 10% loss-to-follow-up rate, we plan to recruit up to 275 participants to achieve sufficient power to declare superiority of the intervention or trial futility. Based on pilot data from the Ear Portal program, we expect to recruit approximately 15 eligible participants per month. Assuming nineteen months of active recruitment, the research team expects to recruit a total of 250 participants.

The primary outcome of the non-surgical resolution of OME four-to-six weeks post-randomisation, and subsequently at six months (up to a maximum of eight months) post-randomisation will be analysed using a Bayesian logistic regression model. The population level parameter estimated is the odd ratio of OME resolution in the intervention arm compared to the control arm.

The participants of the PCH Ear Health Promotion study will receive active monitoring of OME persistence or resolution over 3 months (the standard time required for confirmed OME diagnosis) through the established Ear Portal research recruitment pathway at PCH. This will enable estimation of the spontaneous resolution rate of OME for referral to the PCH ENT Department. Participants allocated to the control arm of the PCH Ear Health Promotion study will enable further estimates of the spontaneous resolution rate of OME after enrolling in the study up until the final study appointment (six to eight months post-randomisation).

We will perform an economic analysis of the cost of diagnosis and care for OME provided through the PCH Ear Health Promotion and the standard care pathways. The units of measure are: i) cost for confirmed diagnosis of persistent OME in $AUD per patient or per patient presenting with OME; ii) treatment costs of OME measured in $AUD and calculated based on the number of children requiring VTI surgery in each group; iii) benefit in terms of number of children in both groups experiencing resolution of OME post-referral to PCH, whether spontaneous or related to the ear health promotion intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2022
Actual
9/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21072 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 35925 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 310124 0
Government body
Name [1] 310124 0
Department of Health - Western Australian Future Health Research & Innovation Fund
Country [1] 310124 0
Australia
Funding source category [2] 310127 0
Other
Name [2] 310127 0
Telethon Kids Institute
Country [2] 310127 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Northern Entrance, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 311196 0
None
Name [1] 311196 0
Address [1] 311196 0
Country [1] 311196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309812 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 309812 0
Ethics committee country [1] 309812 0
Australia
Date submitted for ethics approval [1] 309812 0
16/11/2021
Approval date [1] 309812 0
23/02/2022
Ethics approval number [1] 309812 0
Ethics committee name [2] 309815 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 309815 0
Ethics committee country [2] 309815 0
Australia
Date submitted for ethics approval [2] 309815 0
17/11/2021
Approval date [2] 309815 0
17/03/2022
Ethics approval number [2] 309815 0

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

Contacts
Principal investigator
Name 115474 0
A/Prof Christopher Brennan-Jones
Address 115474 0
PCH Level 6, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country 115474 0
Australia
Phone 115474 0
+61 08 6319 1520
Fax 115474 0
Email 115474 0
chris.brennan-jones@telethonkids.org.au
Contact person for public queries
Name 115475 0
Christopher Brennan-Jones
Address 115475 0
PCH Level 6, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country 115475 0
Australia
Phone 115475 0
+61 08 6319 1520
Fax 115475 0
Email 115475 0
chris.brennan-jones@telethonkids.org.au
Contact person for scientific queries
Name 115476 0
Christopher Brennan-Jones
Address 115476 0
PCH Level 6, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country 115476 0
Australia
Phone 115476 0
+61 08 6319 1520
Fax 115476 0
Email 115476 0
chris.brennan-jones@telethonkids.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


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.