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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 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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityOTHER

2,364 Previous Clinical Trials

3,406,242 Total Patients Enrolled

8 Trials studying Hearing Loss

39,184 Patients Enrolled for Hearing Loss

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,492,450 Total Patients Enrolled

8 Trials studying Hearing Loss

1,640 Patients Enrolled for Hearing Loss

University of KentuckyOTHER

187 Previous Clinical Trials

212,564 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative currently open to new participants?

"Confirmed, this clinical trial is recruiting as per the information posted on clinicaltrials.gov. Initially published in September 1st 2022, it was most recently updated 23 days later."

Answered by AI

Are there any particular characteristics of participants that would make them an ideal fit for this clinical experiment?

"For this trial, 14400 pupils with hearing impairments aged 3 to 11 are being recruited. The essential requirements for enrollment include: attending school in one of the fourteen participating counties, primary entry into elementary education and eligibility without regard to age, gender, race or cultural background."

Answered by AI

What is the total population participating in this research?

"Correct. The clinicaltrials.gov registry outlines that this medical trial is actively looking for participants to join, with the first posting made on September 1st 2022 and most recently edited on the 23rd of September of the same year. Approximately 14400 individuals need to be recruited from one site in total."

Answered by AI

Does this research accommodate elderly patients over 70?

"Participation in the trial is limited to those aged between 3 and 11 years old. There are 53 trials available for minors, and 129 open studies for individuals over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05513833.

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