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

No results posted yet for this study

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
  • Duke University

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513833 on ClinicalTrials.gov