School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky
NCT05513833 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18000
Last updated 2026-05-06
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. 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.
Conditions
Interventions
- OTHER
-
Standard School Screening and Referral
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.
- OTHER
-
Enhanced mHealth Screening
The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.
- OTHER
-
Specialty Telemedicine Referral
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.
Sponsors & Collaborators
-
University of Kentucky
collaborator OTHER - collaborator OTHER
-
National Institutes of Health (NIH)
collaborator NIH -
University of Arkansas
lead OTHER
Principal Investigators
-
Matt Bush, MD, PhD, MBA · University of Kentucky
-
Susan Emmett, MD, MPH · University of Arkansas Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 3 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
Countries
- United States
Study Locations
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