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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Primary and study completion dates: May 30, 2026 to Jun 30, 2027
    • Enrollment target: 14400 to 18000
    • Study description expanded, about 57 words
    v7
  3. 4 versions Re-verified since Jul 11, 2023, no change to tracked fieldsv3-v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05513833
Lead Sponsor University of Arkansas
Collaborators: University of Kentucky, Duke University, National Institutes of Health (NIH)
Conditions
(from sponsor)		 Hearing Loss
Related terms Hearing Loss
Enrollment 18,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov