Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001293156
Ethics application status
Approved
Date submitted
23/08/2019
Date registered
19/09/2019
Date last updated
21/01/2020
Date data sharing statement initially provided
19/09/2019
Date results information initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Ear Explorers: Join us for a journey inside the middle ear. A study to compare still images and videos of the middle ear to diagnose middle ear infections.

Scientific title
Ear Explorers: A prospective study comparing effectiveness of otoscopic still images and videos in remotely diagnosing otitis media. A Perth Children's Hospital (PCH) Ear Portal Sub-study.
Secondary ID [1] 299106 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a sub-study of ACTRN12619000039189p .

Health condition
Health condition(s) or problem(s) studied:
Otitis Media 314156 0
Condition category
Condition code
Ear 312525 312525 0 0
Other ear disorders
Public Health 312526 312526 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants between 6 months and 15 years of age will be recruited opportunistically at Telethon Weekend and NAIDOC community events. Study staff will obtained informed consent and collect a basic screening ear health history. A trained assistant or audiologist will use the HearScope otoscope attached to a smartphone device to take still images and short 10 second videos of the middle ear and a Titan middle ear analyser to do tympanometry (a test to measure the movement of the ear drum) of each ear. The results of these tests will be saved for later comparison and analysis by a blinded consultant. If the results are abnormal and clinically significant, an audiologist will provide the family with counselling and a GP referral. Participation in the project is expected to last approximately 10-15 minutes.

The sub-study will precede the main Ear Portal study, with the findings informing the otoscopic technique (image or videos) that will be used during the main study. Participants in the Ear Explorers sub-study will therefore be recruited independently to the main Ear Portal study and form a separate cohort. They will only complete the Ear Explorers one-off visit and data collection.
Intervention code [1] 315370 0
Diagnosis / Prognosis
Intervention code [2] 315371 0
Early detection / Screening
Intervention code [3] 315372 0
Prevention
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321160 0
Clinician-rated overall quality of still image otoscopy compared to video otoscopy. The clinician will score aspects including image quality, image focus, light, cerumen, field of view and an overall quality assessment on 5-point scales.
Timepoint [1] 321160 0
Based on single day of image/video collection during attendance at community event
Secondary outcome [1] 374144 0
Ability to accurately diagnose middle ear effusion with still image otoscopy compared to video otoscopy. This will be assessed by the blinded clinician who will view the image and video in combination with the screening history and tympanometry result. They will provide an assessment on whether an accurate diagnosis can be made on the basis of the otoscopic views provided.
Timepoint [1] 374144 0
Based on single day of image/video collection during attendance at community event

Eligibility
Key inclusion criteria
1. Children aged 6 months to 15 years of age
2. A parent/guardian is present to provide informed consent for the child to participate

The cohort for this sub-study is separate to the main Ear Portal study; therefore participation in the main study is not an inclusion criteria.
Minimum age
6 Months
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Does not have a parent/guardian present on the day.
2. Contraindications for otoscopy or tympanometry including discharging ear or recent surgery within the last 6 weeks

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size is anticipated to be between 300-400 participants and is based on the track record of previous projects hosted at the Telethon Weekend community event. Data will be analysed/reported using descriptive statistics. The overall ratings for still images and videos provided by the ENT/Audiologist will be compared using an independent t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/10/2019
Actual
26/10/2019
Date of last participant enrolment
Anticipated
30/10/2019
Actual
30/10/2019
Date of last data collection
Anticipated
30/10/2019
Actual
30/10/2019
Sample size
Target
300
Accrual to date
Final
157
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303642 0
Other
Name [1] 303642 0
Telethon Kids Institute
Country [1] 303642 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, Western Australia, 6009
PO Box 855, West Perth, Western Australia, 6872
Country
Australia
Secondary sponsor category [1] 303733 0
None
Name [1] 303733 0
Address [1] 303733 0
Country [1] 303733 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304167 0
Child and Adolescent Health Service HREC
Ethics committee address [1] 304167 0
Perth Children's Hospital
Locked Bag 2010
NEDLANDS WA 6909
Ethics committee country [1] 304167 0
Australia
Date submitted for ethics approval [1] 304167 0
26/08/2019
Approval date [1] 304167 0
26/09/2019
Ethics approval number [1] 304167 0
Ethics committee name [2] 304169 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 304169 0
450 Beaufort Street
Highgate
Western Australia
6003
Ethics committee country [2] 304169 0
Australia
Date submitted for ethics approval [2] 304169 0
23/09/2019
Approval date [2] 304169 0
Ethics approval number [2] 304169 0
15/10/2019

Summary
Brief summary
The Ear Health team currently runs a number of community-based ear health epidemiology, health promotion and telehealth projects. One of the key challenges faced for these projects is having the right equipment to obtain a clear otoscopic image of an ear drum that can be interpreted remotely by specialists.. Effective telehealth programs need appropriate equipment that can provide high-quality images of the ear and be easy to use, as the staff using the equipment may be nurses or health workers with little previous experience of performing otoscopy (ear examinations). During Ear Portal visits, otoscopy is conducted remotely by assistants and transmitted via a store and send method to specialists for review. If remotely provided otoscopic images are of poor quality, the ability to make a diagnosis is hindered resulting in the need for repeat assessment and delays in provision of care.

This is a prospective sub-study which is linked to the PCH Ear Portal main study. Participants will be recruited opportunistically at community events including Telethon Weekend and the Cockburn Integrated Health NAIDOC event in October 2019 . Otoscopic still images and short videos will be obtained using the HearScope. The results will be saved and stored for later review and comparison by ENT/Audiologists along with supporting screening questionnaires and tympanometry. The sub-study results will be used to inform best technique (images or video) for obtaining views of the eardrum by research assistants during the Ear Portal main study to facilitate telehealth assessment by the multidisciplinary team (MDT).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96026 0
Dr Chris Brennan-Jones
Address 96026 0
Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 96026 0
Australia
Phone 96026 0
+61863191520
Fax 96026 0
Email 96026 0
[email protected]
Contact person for public queries
Name 96027 0
Miss Kathryn Jajko
Address 96027 0
Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 96027 0
Australia
Phone 96027 0
+61 863191010
Fax 96027 0
Email 96027 0
[email protected]
Contact person for scientific queries
Name 96028 0
Miss Kathryn Jajko
Address 96028 0
Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 96028 0
Australia
Phone 96028 0
+61 863191010
Fax 96028 0
Email 96028 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4267Study protocol  [email protected]
4268Statistical analysis plan  [email protected]
4269Informed consent form  [email protected]
4270Ethical approval  [email protected]



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.