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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ school screening occurs once per school year, with timing and practices varying by school.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of children screened

Proportion of children who receive follow-up

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out