Hearing LossNCT05513833
School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky
A study testing Standard School Screening and Referral, Enhanced mHealth Screening and Specialty Telemedicine Referral in people with Hearing Loss, run by University of Arkansas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Standard School Screening and Referral, Enhanced mHealth Screening and Specialty Telemedicine Referral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in school in one of the 14 participating counties
- Initial entry into elementary school
- Eligible regardless of age, gender, race, or ethnicity
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Matt Bush, MD, PhD, 859-562-3120
About this study
Official title: Appalachian Specialty Telemedicine Access for Referrals (STAR) 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.
Read the detailed description
Childhood hearing loss has substantial lifelong consequences, including speech-language delay, worse academic performance, and limited vocational opportunities. In rural settings, where access to care is limited, school-based preventative screening programs can help in early identification of childhood hearing loss. The state of Kentucky mandates hearing screening for all schools; however, the effectiveness of these programs is unclear. Further, current school programs do not include a middle ear assessment, which is needed to detect infection-related hearing loss common in children in rural and low-income settings. In children referred from school-based hearing screening programs, loss to follow-up also remains a pervasive issue.
To address these key issues, the University of Kentucky has partnered with the University of Arkansas Medical Sciences to lead the Appalachian STAR 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.
The Appalachian STAR stepped-wedge cluster randomized trial will be conducted in approximately 64 elementary schools located in 14 counties in rural Kentucky. Approximately 3600 students at school entry will be enrolled annually for 4 years, for a total of approximately 14,400 children. Cluster randomization will occur in two sequences at the county level, with 7 counties (clusters) in each sequence. The 4-year trial will include a control condition period, followed by phased roll-out of the intervention. The enhanced mHealth school hearing screening protocol will be implemented first. The following year, specialty telemedicine referral will be added to the enhanced screening protocol. All 14 counties will receive the STAR model by the end of the trial. An implementation evaluation will be conducted to refine the STAR model throughout the trial. If successful, the STAR model could be applied to address hearing loss and other childhood health conditions that affect underserved rural communities across America.
Timeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. After this additional year of enhanced screening only, specialty telemedicine referral will be added to the enhanced screening protocol. All counties will receive the STAR model by the end of the 5-year trial.
- Conditions
- Hearing Loss
- Being tested
- Standard School Screening and Referral, Enhanced mHealth Screening, Specialty Telemedicine Referral
- Keywords
- Rural, hearing, loss, telemedicine, telehealth, school, disparities, screening
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard School Screening and ReferralOther
Counties in the control condition will use standard hearing screening and standard referral by school district. Standard referral is typically a letter home from the school to parents/caregivers of children who refer screening.
Enhanced mHealth ScreeningOther
The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.
Specialty Telemedicine ReferralOther
The specialty telemedicine referral will include a lay-friendly smartphone or tablet that connects to tools necessary for an ear and hearing evaluation. If a child requires referral from hearing screening, a school nurse/teacher will complete the established protocol for the specialty telemedicine referral and send details asynchronously to an audiologist for consultation.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | 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. Receives: Other: Standard School Screening and Referral; Other: Enhanced mHealth Screening; Other: Specialty Telemedicine Referral |
| Sequence 2 | Other | 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. Receives: Other: Standard School Screening and Referral; Other: Enhanced mHealth Screening; Other: Specialty Telemedicine Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children screened
This outcome will be measured at the end of each annual screening period for each school, for 5 years, based on the updated timeline.
Measured: School screening occurs once per school year, with timing and practices varying by school.
Proportion of children who receive follow-up
This outcome will be measured each school year, for 3 years or 4 years depending on sequence randomization, based on the updated timeline.
Measured: Proportion of children who receive follow-up will be measured by the occurrence of an ear/hearing encounter, up to 60 days from the date of screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 14 total counties (clusters) are participating in the stepped wedge randomized trial. There are two nested trials within the overall stepped-wedge trial: a complete design to evaluate the enhanced mHealth screening component and an incomplete design to evaluate the specialty telemedicine referral component combined with enhanced screening. Clusters will be randomized to cross over to enhanced mHealth hearing screening and specialty telemedicine referral in a stepwise manner until all clusters receive both the interventions. The enhanced mHealth screening component will be rolled out in Years 2 or 3 (control period in Years 1 and 2) depending on sequence randomization. Specialty telemedicine referral will be rolled out in Years 3 and 4 (control period in Years 2 and 3) depending on sequence randomization. Timeline update: With the trial extended by one year, rollout of specialty telemedicine referral will be shifted to Years 4 and 5 depending on sequence randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, Duke University, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Matt Bush, MD, PhD, MBA, Principal investigator, University of KentuckySusan Emmett, MD, MPH, Principal investigator, University of Arkansas Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513833
- Sponsor's protocol ID
- 274089
- Other IDs
- 1U01OD033247
- Status last verified
- May 2026
- First submitted
- 14 Aug 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study focuses on population outcomes. School and health data will remain with local education and healthcare entities, and the study team will receive deidentified information. Data sharing will be considered upon request pending appropriate local approval.
Publications
Srinivasan T, Kleindienst Robler S, Turner E, Platt A, Arthur D, Prvu Bettger J, Lane H, Schuh Gebert M, Deshpande S, Schoenberg N, Bush ML, Emmett SD. Improving Access to Specialty Care for Rural Children Using Enhanced Hearing Screening and Specialty Telehealth Follow-Up in Rural Kentucky Schools: Protocol for a Hybrid Effectiveness-Implementation Stepped Wedge, Cluster-Randomized Controlled Trial (Appalachian STAR Trial). JMIR Res Protoc. 2025 Aug 26;14:e77630. doi: 10.2196/77630.
PubMed 40858294
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial
- ClinicalTrials.gov ID
- NCT05513833
- Acronym / sponsor ID
- 274089
- Conditions
- Hearing Loss
- Keywords
- Rural, hearing, loss, telemedicine, telehealth, school, disparities, screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- University of Kentucky, Duke University, National Institutes of Health (NIH)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Childhood hearing loss has substantial lifelong consequences, including speech-language delay, worse academic performance, and limited vocational opportunities. In rural settings, where access to care is limited, school-based preventative screening programs can help in early identification of childhood hearing loss. The state of Kentucky mandates hearing screening for all schools; however, the effectiveness of these programs is unclear. Further, current school programs do not include a middle ear assessment, which is needed to detect infection-related hearing loss common in children in rural and low-income settings. In children referred from school-based hearing screening programs, loss to follow-up also remains a pervasive issue.
To address these key issues, the University of Kentucky has partnered with the University of Arkansas Medical Sciences to lead the Appalachian STAR 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.
The Appalachian STAR stepped-wedge cluster randomized trial will be conducted in approximately 64 elementary schools located in 14 counties in rural Kentucky. Approximately 3600 students at school entry will be enrolled annually for 4 years, for a total of approximately 14,400 children. Cluster randomization will occur in two sequences at the county level, with 7 counties (clusters) in each sequence. The 4-year trial will include a control condition period, followed by phased roll-out of the intervention. The enhanced mHealth school hearing screening protocol will be implemented first. The following year, specialty telemedicine referral will be added to the enhanced screening protocol. All 14 counties will receive the STAR model by the end of the trial. An implementation evaluation will be conducted to refine the STAR model throughout the trial. If successful, the STAR model could be applied to address hearing loss and other childhood health conditions that affect underserved rural communities across America.
Timeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. After this additional year of enhanced screening only, specialty telemedicine referral will be added to the enhanced screening protocol. All counties will receive the STAR model by the end of the 5-year trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 14 total counties (clusters) are participating in the stepped wedge randomized trial. There are two nested trials within the overall stepped-wedge trial: a complete design to evaluate the enhanced mHealth screening component and an incomplete design to evaluate the specialty telemedicine referral component combined with enhanced screening. Clusters will be randomized to cross over to enhanced mHealth hearing screening and specialty telemedicine referral in a stepwise manner until all clusters receive both the interventions. The enhanced mHealth screening component will be rolled out in Years 2 or 3 (control period in Years 1 and 2) depending on sequence randomization. Specialty telemedicine referral will be rolled out in Years 3 and 4 (control period in Years 2 and 3) depending on sequence randomization. Timeline update: With the trial extended by one year, rollout of specialty telemedicine referral will be shifted to Years 4 and 5 depending on sequence randomization.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Other: Standard School Screening and Referral, Other: Enhanced mHealth Screening, Other: Specialty Telemedicine ReferralStandard 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. |
| Sequence 2 | Other | Other: Standard School Screening and Referral, Other: Enhanced mHealth Screening, Other: Specialty Telemedicine ReferralStandard 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. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled in school in one of the 14 participating counties
- Initial entry into elementary school
- Eligible regardless of age, gender, race, or ethnicity
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard School Screening and ReferralCounties in the control condition will use standard hearing screening and standard referral by school district. Standard referral is typically a letter home from the school to parents/caregivers of children who refer screening. | Other | Sequence 1, Sequence 2 |
| Enhanced mHealth ScreeningThe enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry. | Other | Sequence 1, Sequence 2 |
| Specialty Telemedicine ReferralThe specialty telemedicine referral will include a lay-friendly smartphone or tablet that connects to tools necessary for an ear and hearing evaluation. If a child requires referral from hearing screening, a school nurse/teacher will complete the established protocol for the specialty telemedicine referral and send details asynchronously to an audiologist for consultation. | Other | Sequence 1, Sequence 2 |
Primary outcome
Proportion of children screened
Time frame: School screening occurs once per school year, with timing and practices varying by school.
This outcome will be measured at the end of each annual screening period for each school, for 5 years, based on the updated timeline.
Proportion of children who receive follow-up
Time frame: Proportion of children who receive follow-up will be measured by the occurrence of an ear/hearing encounter, up to 60 days from the date of screening.
This outcome will be measured each school year, for 3 years or 4 years depending on sequence randomization, based on the updated timeline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 40858294Srinivasan T, Kleindienst Robler S, Turner E, Platt A, Arthur D, Prvu Bettger J, Lane H, Schuh Gebert M, Deshpande S, Schoenberg N, Bush ML, Emmett SD. Improving Access to Specialty Care for Rural Children Using Enhanced Hearing Screening and Specialty Telehealth Follow-Up in Rural Kentucky Schools: Protocol for a Hybrid Effectiveness-Implementation Stepped Wedge, Cluster-Randomized Controlled Trial (Appalachian STAR Trial). JMIR Res Protoc. 2025 Aug 26;14:e77630. doi: 10.2196/77630.
- Individual participant dataSharing planned: Yes. This study focuses on population outcomes. School and health data will remain with local education and healthcare entities, and the study team will receive deidentified information. Data sharing will be considered upon request pending appropriate local approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matt Bush, MD, PhD, MBA principal investigator
University of Kentucky
Susan Emmett, MD, MPH principal investigator
University of Arkansas Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard School Screening and Referral, Enhanced mHealth Screening and Specialty Telemedicine Referral in people with Hearing Loss, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Emmett, MD, MPH (501-603-1212, sdemmett@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children screened (time frame: School screening occurs once per school year, with timing and practices varying by school.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05513833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.