Actively Recruiting

Phase Not Applicable
Age: 3Years - 11Years
All Genders
Healthy Volunteers
NCT05513833

School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky

Led by University of Arkansas · Updated on 2026-05-06

18000

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

Sponsors

U

University of Arkansas

Lead Sponsor

U

University of Kentucky

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky

Who Can Participate

Age: 3Years - 11Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Enrolled in school in one of the 14 participating counties
  • Initial entry into elementary school
  • Eligible regardless of age, gender, race, or ethnicity
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

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Research Team

S

Susan Emmett, MD, MPH

CONTACT

S

Samantha Robler, AuD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky | DecenTrialz