Health TrialsbyHealthPanel

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

ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-11
SponsorUniversity of Arkansas

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Enrolled in school in one of the 14 participating counties

Initial entry into elementary school

Eligible regardless of age, gender, race, or ethnicity

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Standard School Screening and Referral

    Other intervention

    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 Screening

    Other intervention

    The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.

  • Specialty Telemedicine Referral

    Other intervention

    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.

Treatment groups

18,000 Participants
are divided into 2 treatment groups
Group A: Sequence 1Other 3 interventions
Group B: Sequence 2Other 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
School screening occurs once per school year, with timing and practices varying by school.
2

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arkansas

Lead sponsor

University of Kentucky

Collaborator

Duke University

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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