Trial Summary
What is the purpose of this trial?This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.
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 data supports the effectiveness of the treatment Enhanced Hearing Screening + Telemedicine Referral for Childhood Hearing Loss?
Research shows that using telemedicine for ear screening in Indigenous communities in Queensland effectively identified children at risk of hearing impairment, leading to timely specialist referrals and improved access to care. Additionally, mobile health screening and telemedicine referrals in rural Alaska improved follow-up times for school hearing screenings, suggesting that similar approaches can enhance access to specialty care for childhood hearing loss.
12345Is the Enhanced Hearing Screening + Telemedicine Referral for Childhood Hearing Loss safe for children?
The available research on mobile health and telemedicine-based hearing screening programs, including those using tablets and smartphones, suggests they are generally safe for children. These programs have been effectively used in various communities to screen for hearing issues without reported safety concerns.
13678How is the Enhanced mHealth Screening treatment different from other treatments for childhood hearing loss?
The Enhanced mHealth Screening treatment is unique because it uses mobile health technology and telemedicine to screen and refer children for hearing loss, allowing specialists to assess children remotely and improving access to care, especially in rural or underserved areas. This approach is different from traditional methods that require in-person visits and may not be as accessible for all children.
123910Eligibility Criteria
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
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Sequence 2Experimental Treatment3 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 and 3.
Enhanced mHealth screening component: Counties randomized to Sequence 2 will receive the enhanced mHealth screening in Years 3 and 4.
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 4.
Group II: Sequence 1Experimental Treatment3 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 and 2.
Enhanced mHealth screening component: Counties randomized to Sequence 1 will receive the enhanced mHealth screening in Years 2, 3, and 4.
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 3 and 4.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of KentuckyLexington, KY
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Who Is Running the Clinical Trial?
University of ArkansasLead Sponsor
Duke UniversityCollaborator
National Institutes of Health (NIH)Collaborator
University of KentuckyCollaborator
References
A mobile telemedicine-enabled ear screening service for Indigenous children in Queensland: activity and outcomes in the first three years. [2022]A mobile ear-screening service was established in an Aboriginal community in central Queensland. Telemedicine allowed ear nose and throat (ENT) specialists at the tertiary children's hospital in Brisbane to assess children at a distance using pre-recorded information comprising video-otoscopic images and the results of tympanometry and audiometry. During the first three years, 1053 children were registered with the service. A total of 2111 screening assessments were carried out at 21 schools in the region. The average screening rate achieved in the community was 85%. More than half of all assessments resulted in a referral to the ENT specialist (for online assessment) or local doctor (for treatment). Twenty specialist ENT online clinics were conducted during which 415 patients were reviewed. Over half of all online review cases (55%) resulted in appointments at the next ENT outreach clinic for further review and/or surgery. The community-based screening service led by local Indigenous health workers, and linked to a tertiary children's hospital by telemedicine, was an effective method for routine screening of children at risk of hearing impairment.
Screening for hearing loss in childhood: issues, evidence and current approaches in the UK. [2016]Until recently, screening for childhood hearing loss in the UK was based on two universal (i.e. whole population) screens: the infant distraction test screen at age eight months and the school entry hearing screen at age four to five years. Evidence reviewed in the 1990s indicated that the infant distraction test screen was seriously underperforming, but that (based on technology that had become available in the 1980s and 1990s) universal newborn hearing screening could be efficacious. At the same time, evidence was emerging on the importance and value of very early identification and intervention for permanent congenital childhood hearing loss. This led to the decision to implement a national newborn hearing screening programme (NHSP) in England and to phase out the distraction test at eight months. The initial implementation of the programme will be completed in 2005, and we summarize the evidence on the effectiveness of the first phase of the programme here. A number of important issues concerning childhood hearing loss and its management remain unresolved: the burden of late-onset and temporary childhood hearing losses, the most effective approaches to intervention and management, the case for screening for mild and/or unilateral hearing loss, and the role of the School entry screen. Some of the current research efforts to address these are outlined.
Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial. [2023]School-based programmes, including hearing screening, provide essential preventive services for rural children. However, minimal evidence on screening methodologies, loss to follow-up, and scarcity of specialists for subsequent care compound rural health disparities. We hypothesised telemedicine specialty referral would improve time to follow-up for school hearing screening compared with standard primary care referral.
Monitoring ear health through a telemedicine-supported health screening service in Queensland. [2022]The prevalence of ear disease and hearing loss is greater for Indigenous children than for their non-Indigenous counterparts. In 2009, we established a mobile ear-screening service in South Burnett, in which an Indigenous Health Worker (IHW) assesses children at school and shares results by telemedicine with ear, nose and throat (ENT) specialists, who in turn provide review and biannual surgical outreach to the community. We reviewed service data for the first six years of the service (Jan 2009-Dec 2014), to calculate: total number of completed assessments; total number of patients failing at least one screening test; and overall proportion of failed screening assessments per annum. Subgroup analysis was conducted by usual home postcode. The service has provided 5539 screening assessments. The mean screening failure rate for children outside of postcode 4605 (Cherbourg/Murgon area) was 22% (range 17-29%) and 38% for children living inside postcode 4605 (range 34-41%). While screening activity has increased by more than 50% since 2009, there has been a slight reduction in the proportion of children failing assessment, with the mean failure rate changing from 33% in 2009 to 26% in 2014. These early results suggest that community-based screening, integrated with specialist ENT services may improve ear and hearing health.
Childhood hearing loss detected beyond the newborn screen. [2023]To understand the characteristics of postnatal hearing loss (PNHL) identified via different referral pathways, to inform childhood hearing screening and referral practices.
Mhealth hearing screening for children by non-specialist health workers in communities. [2021]To compare outcomes of a community-based hearing screening programme using smartphone screening audiometry operated by specialist (School Health Nurses - SHNs) and non-specialist health workers (Community Health Workers - CHWs) in school children.
Tablet-Based Hearing Screening Test. [2018]Hearing loss (HL) affects people worldwide, many of whom are children. Especially in developing countries, epidemiological data on the prevalence of HL are insufficient to implement effective health promotion programs. In this preliminary study with young adults, we describe and validate a tablet-based hearing screening test developed for interactive remote hearing screening and compare the performance of an audiometry screening tablet application with conventional audiometry. In addition, the sensitivity, specificity, and predictive values of the tablet-based method and the concordance between the two methods were analyzed.
Evaluation of a game-based hearing screening program for identifying hearing loss in primary school-aged children. [2023]To evaluate a tablet-based hearing screening game in primary school aged children. To examine the prevalence of middle/outer ear pathology, hearing loss and spatial processing disorder in primary school aged children.
Improving the access of young urban children to speech, language and hearing screening via telehealth. [2011]We studied the feasibility of low-cost videoconferencing (using Skype) in urban community health clinics for speech, language and hearing screening of children up to six years of age. During a two-year study, screening services were provided via videoconferencing at two community clinics in an inner city area of Cleveland, Ohio. In total, 411 screenings were completed. Of these, 358 children (87%) received hearing screenings, 377 (92%) received tympanometry screening and 263 (64%) received speech and language screening only. A total of 151 children were aged three years or under (37%). The reliability of pure tone hearing screening (n = 7), DPOAE screening (n = 51) and speech-language screening (n = 10) was 100%. Typanometry screenings (n = 55) were 84% reliable. Families reported a high level of satisfaction with both the technology and with the videoconferencing. The results indicate that low-cost videoconferencing for screening of speech, language and hearing development in very young children in urban community health clinics is feasible, reliable and strongly supported by the community.
The use of telehealth services to facilitate audiological management for children: A scoping review and content analysis. [2018]Approximately 32 million children globally present with disabling hearing loss. Despite evidence describing the negative consequences of hearing loss, there is still a lack of hearing screening programmes in South Africa. Audiologists have been exploring the use of information and communication technologies (tele-audiology) to provide services to children and it is currently being evaluated to determine its feasibility. Aims We aim to describe tele-audiology services conducted to facilitate audiological management for children in both the rural and urban context and to determine the strengths, challenges and clinical implications of such services. Methods A scoping review was conducted by searching for peer-reviewed publications from five databases. Inclusion criteria and search strategies were outlined. Results Of the 23 studies that met the inclusion criteria, reliability of automated testing was comparable to conventional testing; however, these studies were based primarily on screening programmes. Eight (35%) of the 23 papers were concordance studies evaluating feasibility and validity of tele-audiology systems when compared with conventional testing, while one study (4%) evaluated a tele-audiology service. A further four studies (17%) evaluated the feasibility of introducing telehealth methods to evaluate middle ear pathology. Tele-auditory brainstem response was investigated in three studies (13%) and another five (22%) used smartphone and/or iPad technology to screen hearing. Only two studies (9%) evaluated the feasibility of providing intervention through telehealth methods. All included studies demonstrated improved access to and coverage of rural areas. Services such as video otoscopy and synchronous (online) hearing testing in remote areas were successfully implemented. Challenges included lack of diagnostic studies, inadequate training of staff and the need to standardize protocols and procedures in order to ensure that tele-audiology services are provided in a standardized and valid manner. Conclusion Tele-audiology services are feasible and can be useful in identifying auditory pathology for children in rural and remote areas.