Enhanced Hearing Screening + Telemedicine Referral for Childhood Hearing Loss

Overseen By Susan Emmett, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

18000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve hearing care for children in rural Kentucky by testing a new approach that combines mobile health screening with telemedicine referrals. Researchers aim to make follow-up care more accessible for children by using technology to identify hearing issues and connect with specialists. The trial will compare standard school hearing screenings to an enhanced version, Enhanced mHealth Screening, which includes checks for middle ear problems. Children starting elementary school in one of the 14 participating counties are eligible to join this trial. As an unphased trial, this study offers families a unique opportunity to contribute to innovative healthcare solutions that could benefit their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this multilevel intervention is safe for childhood hearing screening?

Research shows that mobile health (mHealth) technology for hearing tests is safe and well-received. A study in South Africa found that mHealth tools for hearing and vision tests in preschool children worked well and caused no harm, confirming the technology's safety for children.

Regarding telemedicine referrals, past studies have shown them to be safe and effective for providing children with specialized care. For example, a study in Alaska schools used telemedicine to help children with hearing loss receive care faster, without negative effects.

In summary, both mHealth screening and telemedicine referral have been safely used in similar situations before, suggesting they will be safe for children in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of enhanced mHealth screening combined with telemedicine referrals to improve the detection and management of childhood hearing loss. Unlike traditional school hearing screenings and referrals, which may miss cases or delay specialist consultations, this approach uses mobile health technology to provide more accurate and timely screenings. Additionally, the integration of telemedicine referrals is designed to connect families with specialists more quickly, potentially leading to earlier interventions and better outcomes for children with hearing loss.

What evidence suggests that this trial's treatments could be effective for childhood hearing loss?

Research has shown that a new mobile health (mHealth) screening tool, which participants in this trial may receive, can effectively detect moderate to severe hearing loss in young children. One study demonstrated that community health workers successfully used this mobile method to identify hearing issues. Additionally, using telemedicine for specialist referrals, another component under study in this trial, has improved follow-up rates and sped up the time it takes for children to see a specialist, especially in rural areas like Alaska. This approach makes hearing care more accessible and timely for children who need it. These findings suggest that combining the mHealth screening with telemedicine referrals, as tested in this trial, could effectively address childhood hearing loss, particularly in underserved areas. ^{1 6 7 8 9}

Who Is on the Research Team?

Susan Emmett, MD, MPH

Principal Investigator

University of Arkansas Medical Sciences

Matt Bush, MD, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for children entering elementary school in one of the 14 participating counties in rural Kentucky. It's open to all kids, no matter their age, gender, race, or ethnicity. There are no specific exclusion criteria mentioned.

Inclusion Criteria

My eligibility is not limited by my age, gender, race, or ethnicity.

Enrolled in school in one of the 14 participating counties

Initial entry into elementary school

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 years

Annual school-based screening

Control Period

Standard hearing screening and referral process in place before intervention

1-2 years

Enhanced mHealth Screening

Implementation of enhanced mHealth screening protocol including tympanometry

1-2 years

Specialty Telemedicine Referral

Addition of telemedicine referral process to enhanced screening protocol

1-2 years

Follow-up

Participants are monitored for follow-up after screening and referral

Up to 60 days from the date of screening

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced mHealth Screening
• Specialty Telemedicine Referral
• Standard School Screening and Referral

Trial Overview The study tests a new approach (STAR model) that uses mobile health tools and telemedicine to improve hearing loss screening and follow-up care in rural schools. It includes an enhanced mHealth screening with tympanometry and a specialty telemedicine referral process.

How Is the Trial Designed?

Group I: Sequence 2 Experimental Treatment 3 Interventions

Standard Hearing Screening: All counties in Sequence 2 will receive standard hearing screening in the control period, Years 1 and 2. Standard Referral: All counties in Sequence 2 will receive standard referral in control period, Years 1, 2, 3, and 4, based on the updated timeline. Enhanced mHealth screening component: Counties randomized to Sequence 2 will receive the enhanced mHealth screening in Years 3, 4, and 5, based on the updated timeline. Specialty telemedicine referral component: Counties randomized to Sequence 2 will receive the specialty telemedicine referral component in addition to the enhanced mHealth screening in Year 5, based on the updated timeline.

Group II: Sequence 1 Experimental Treatment 3 Interventions

Standard School Screening: All counties in Sequence 1 will receive standard hearing screening in the control period, Year 1. Standard Referral: All counties in Sequence 1 will receive standard referral in control period, Years 1, 2, and 3, based on the updated timeline. Enhanced mHealth screening component: Counties randomized to Sequence 1 will receive the enhanced mHealth screening in Years 2, 3, 4, and 5, based on the updated timeline. Specialty telemedicine referral component: Counties randomized to Sequence 1 will receive the specialty telemedicine referral component in addition to the enhanced mHealth screening in Years 4 and 5, based on the updated timeline.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Published Research Related to This Trial

Tele-audiology services have been shown to be feasible and effective in identifying hearing issues in children, particularly in rural and remote areas, improving access to necessary audiological care.

While the reliability of automated testing in tele-audiology is comparable to conventional methods, challenges such as the need for standardized protocols and staff training remain to be addressed for optimal service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of telehealth services to facilitate audiological management for children: A scoping review and content analysis. Govender, SM., Mars, M.[2018]

A tablet-based hearing screening test was validated in a study with 30 young adult volunteers, showing perfect concordance with conventional audiometry results, indicating it can reliably identify hearing loss.

The tablet method demonstrated excellent sensitivity and specificity, both at 100%, making it a highly accurate tool for hearing screening, especially useful in areas lacking access to audiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet-Based Hearing Screening Test. Samelli, AG., Rabelo, CM., Sanches, SGG., et al.[2018]

A community-based hearing screening program using smartphone audiometry showed no significant difference in outcomes between specialist School Health Nurses (SHNs) and non-specialist Community Health Workers (CHWs) when screening 6805 children.

The study found that factors like age, test duration, and noise levels significantly affected screening results, indicating that even minimally trained individuals can effectively conduct hearing screenings using mobile technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mhealth hearing screening for children by non-specialist health workers in communities. Dawood, N., Mahomed Asmail, F., Louw, C., et al.[2021]

The mobile ear-screening service in an Aboriginal community successfully screened 1053 children over three years, achieving an impressive average screening rate of 85%.

More than half of the assessments led to referrals for further evaluation or treatment, demonstrating the effectiveness of telemedicine in connecting local health workers with specialist ENT care for children at risk of hearing impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile telemedicine-enabled ear screening service for Indigenous children in Queensland: activity and outcomes in the first three years. Smith, AC., Armfield, NR., Wu, WI., et al.[2022]

In a study involving 1481 children from 15 rural Alaskan communities, telemedicine specialty referral significantly reduced the time to follow-up after positive hearing screenings, with an average of 41.5 days compared to 92.0 days for standard primary care referrals.

The telemedicine approach also resulted in a higher follow-up rate, with 68.5% of children receiving follow-up care compared to only 32.1% in the primary care group, demonstrating its effectiveness in improving access to necessary healthcare services for rural children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial. Emmett, SD., Platt, A., Turner, EL., et al.[2023]

A mobile ear-screening service established in South Burnett has conducted 5,539 assessments over six years, showing a slight reduction in the proportion of children failing screening tests from 33% in 2009 to 26% in 2014.

Children living in the Cherbourg/Murgon area (postcode 4605) had a higher screening failure rate of 38%, indicating that targeted community-based interventions may be necessary to improve ear and hearing health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring ear health through a telemedicine-supported health screening service in Queensland. Smith, AC., Brown, C., Bradford, N., et al.[2022]

The tablet-based hearing screening game, Sound Scouts, effectively identified undiagnosed hearing deficits in a study of 1256 primary school children, revealing that 8.84% had middle/outer ear pathologies and 1.67% had hearing loss.

The study highlights the importance of school-based hearing screenings, as it established the prevalence of hearing abnormalities and demonstrated a low false positive rate of 5.01%, indicating that most children who failed the initial screening did not have actual hearing issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a game-based hearing screening program for identifying hearing loss in primary school-aged children. Bowers, P., Graydon, K., Rance, G.[2023]

Children with postnatal hearing loss (PNHL) identified through neonatal risk factors were diagnosed earlier (average age of 31 months) and with milder severity compared to those detected through other pathways (average age of 49 months).

Screening programs that focus on children with speech and language delays or significant medical histories are essential, as they identify a higher proportion of more severe cases of PNHL, indicating that current screening practices may need to be adjusted to improve early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood hearing loss detected beyond the newborn screen. Fitzgibbons, EJ., Keszegi, S., Driscoll, C., et al.[2023]

A two-year study in Cleveland demonstrated that low-cost videoconferencing for speech, language, and hearing screenings in children under six is feasible and reliable, with 100% reliability for hearing and speech-language screenings.

Out of 411 screenings conducted, families expressed high satisfaction with the technology, indicating strong community support for this innovative approach in urban health clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the access of young urban children to speech, language and hearing screening via telehealth. Ciccia, AH., Whitford, B., Krumm, M., et al.[2011]

The UK has transitioned from using the ineffective infant distraction test for hearing loss screening to implementing a national newborn hearing screening program (NHSP), which is based on more advanced technology and aims for early detection of hearing issues.

The NHSP is expected to improve early identification and intervention for permanent congenital childhood hearing loss, although challenges remain regarding the management of late-onset and temporary hearing losses, as well as the effectiveness of screening for milder cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for hearing loss in childhood: issues, evidence and current approaches in the UK. Bamford, J., Uus, K., Davis, A.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11773282/

Development and Beta Validation of an mHealth-Based ... This study aims to develop and beta-validate an affordable hearing screener for children younger than 6 years of age to identify moderately severe or higher ...

2. withpower.com withpower.com/trial/phase-hearing-loss-8-2022-0127f

Enhanced Hearing Screening + Telemedicine Referral for ... This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/14992027.2020.1829719

Mhealth hearing screening for children by non-specialist ... This study used a two-group comparison of screening outcomes as conducted by SHNs and CHWs using smartphone screening for children in communities.

4. reporter.nih.gov reporter.nih.gov/project-details/11187195

Project Details - NIH RePORTER We propose to validate and then trial an innovative mHealth model for end-to-end hearing care facilitated by community health workers (CHWs). The smartphone- ...

5. researchprotocols.org researchprotocols.org/2025/1/e77630

Improving Access to Specialty Care for Rural Children ... The core components of the STAR model include enhanced hearing screening; specialty telehealth follow-up; and streamlined communication ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796667/

Hearing and vision screening for preschool children using ... A community-based hearing and vision screening programme for preschool children in the Western Cape, South Africa, supported by mobile health technology ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10483300/

Mobile Health Hearing Aid Acclimatization and Support ... This study aimed to evaluate the feasibility of an mHealth acclimatization and support program supported by CHWs in low-income communities.

8. mhealth.jmir.org mhealth.jmir.org/2020/11/e23047/

A Smartphone-Based Approach to Screening for Sudden ... This study aimed to determine the correlation between hearing outcomes measured by conventional pure-tone audiometry and those measured by the proposed ...

9. researchgate.net researchgate.net/publication/392132846_School-based_enhanced_hearing_screening_and_specialty_telehealth_follow-up_for_hearing_loss_among_children_in_rural_Alaska_study_protocol_for_a_hybrid_effectiveness-implementation_stepped_wedge_cluste

School-based enhanced hearing screening and specialty ... The trial will evaluate the STAR model, which consists of three core components: (1) enhanced school hearing screening, (2) school-based ...