RecruitingACTRN12622000546752

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.

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.

Sponsor

Telethon Kids Institute

Enrollment

250 participants

Start Date

Feb 9, 2023

Study Type

Interventional

Conditions

Otitis Media with Effusion

Summary

Middle ear infections, known as otitis media (OM), are the leading cause of hearing loss in children and are estimated to affect over 90% of children at least once before their second birthday. Persistent otitis media with effusion (OME) and its associated hearing loss can have long-term impacts on a child’s language, communication, behavioural skills, literacy and educational experience, that will affect their relationships with others, educational outcomes and later employment prospects. Whilst the prevalence of OME is high, we know that some children will experience spontaneous resolution of OME (i.e. return to having an intact and well-functioning eardrum), and therefore will not require Ventilation Tube Insertion surgery (more commonly known as grommets). Currently, we do not know how many children could be expected to experience spontaneous resolution of OME. Some simple, low-cost, family-led health promotion programs have been developed to help improve resolution of OME without surgical intervention. This project aims to determine whether the implementation of these health promotion programs within an innovative telehealth service model will increase the non-surgical resolution of OME.

Eligibility

Sex: Both males and femalesMin Age: 3 YearssMax Age: 7 Yearss

Inclusion Criteria7

Children aged between three years old and seven years old.
Children identified during the triage of initial referral to PCH for hearing or ear-related presenting complaints.
Children who have the capacity to comply with study procedures, including follow up, regardless of residential geographical location.
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.

Exclusion Criteria6

Children who are known to be scheduled to undergo surgical intervention within four weeks.
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.
Children who are actively participating in another ear intervention study.
Children are unable to comply with relevant study procedures due to any physical, medical, developmental, behavioural or cognitive condition.
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.
The child’s legal representative is unwilling or unable to provide informed consent for the minor to participate in the study.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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').