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Enhanced Hearing Screening + Telemedicine Referral for Childhood Hearing Loss

N/A
Recruiting
Led By Matt Bush, MD, PhD, MBA
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up school screening occurs once per school year, with timing and practices varying by school.
Awards & highlights

Study Summary

This trial will evaluate a new way of screening for and referring children with hearing problems in rural schools, using mobile health tools and telemedicine.

Who is the study for?
This trial is for children entering elementary school in one of the 14 participating counties in rural Kentucky. It's open to all kids, no matter their age, gender, race, or ethnicity. There are no specific exclusion criteria mentioned.Check my eligibility
What is being tested?
The study tests a new approach (STAR model) that uses mobile health tools and telemedicine to improve hearing loss screening and follow-up care in rural schools. It includes an enhanced mHealth screening with tympanometry and a specialty telemedicine referral process.See study design
What are the potential side effects?
Since this trial involves non-invasive screening methods and referrals rather than direct medical treatments or drugs, there are likely minimal to no side effects associated with participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~school screening occurs once per school year, with timing and practices varying by school.
This trial's timeline: 3 weeks for screening, Varies for treatment, and school screening occurs once per school year, with timing and practices varying by school. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of children screened
Proportion of children who receive follow-up

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sequence 2Experimental Treatment3 Interventions
Standard Hearing Screening: All counties in Sequence 2 will receive standard hearing screening in the control period, Years 1 and 2 Standard Referral: All counties in Sequence 2 will receive standard referral in control period, Years 1, 2 and 3. Enhanced mHealth screening component: Counties randomized to Sequence 2 will receive the enhanced mHealth screening in Years 3 and 4. Specialty telemedicine referral component: Counties randomized to Sequence 2 will receive the specialty telemedicine referral component in addition to the enhanced mHealth screening in Year 4.
Group II: Sequence 1Experimental Treatment3 Interventions
Standard School Screening: All counties in Sequence 1 will receive standard hearing screening in the control period, Year 1 Standard Referral: All counties in Sequence 1 will receive standard referral in control period, Years 1 and 2. Enhanced mHealth screening component: Counties randomized to Sequence 1 will receive the enhanced mHealth screening in Years 2, 3, and 4. Specialty telemedicine referral component: Counties randomized to Sequence 1 will receive the specialty telemedicine referral component in addition to the enhanced mHealth screening in Years 3 and 4.

Find a Location

Who is running the clinical trial?

Duke UniversityOTHER
2,386 Previous Clinical Trials
3,043,037 Total Patients Enrolled
8 Trials studying Hearing Loss
39,184 Patients Enrolled for Hearing Loss
National Institutes of Health (NIH)NIH
2,726 Previous Clinical Trials
7,481,509 Total Patients Enrolled
8 Trials studying Hearing Loss
1,640 Patients Enrolled for Hearing Loss
University of KentuckyOTHER
188 Previous Clinical Trials
211,770 Total Patients Enrolled
2 Trials studying Hearing Loss
30 Patients Enrolled for Hearing Loss

Media Library

Enhanced mHealth Screening Clinical Trial Eligibility Overview. Trial Name: NCT05513833 — N/A
Hearing Loss Research Study Groups: Sequence 1, Sequence 2
Hearing Loss Clinical Trial 2023: Enhanced mHealth Screening Highlights & Side Effects. Trial Name: NCT05513833 — N/A
Enhanced mHealth Screening 2023 Treatment Timeline for Medical Study. Trial Name: NCT05513833 — N/A
~7527 spots leftby May 2026
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