Recruiting

STAR Model

Sponsor:

University of Arkansas

Code:

NCT05513833

Conditions

Hearing Loss

Eligibility Criteria

Sex: All

Age: 3 - 11

Healthy Volunteers: Accepted

Interventions

Standard School Screening and Referral

Enhanced mHealth Screening

Specialty Telemedicine Referral

Study Details

Brief summary:

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.

Conditions

Hearing Loss

Study ID

NCT05513833

Start date

Sep 1, 2022

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 11

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Enrolled in school in one of the 14 participating counties
  • Initial entry into elementary school
  • Eligible regardless of age, gender, race, or ethnicity

Exclusion Criteria:

• N/A

Study Design

Enrollment

18000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Sequence 1

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, 2, and 3, based on the updated timeline.

Enhanced mHealth screening component: Counties randomized to Sequence 1 will receive the enhanced mHealth screening in Years 2, 3, 4, and 5, based on the updated timeline.

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 4 and 5, based on the updated timeline.

other: Sequence 2

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, 3, and 4, based on the updated timeline.

Enhanced mHealth screening component: Counties randomized to Sequence 2 will receive the enhanced mHealth screening in Years 3, 4, and 5, based on the updated timeline.

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 5, based on the updated timeline.

Interventions

Standard School Screening and Referral

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

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

Specialty Telemedicine Referral

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.

Primary outcome measure

  • Proportion of children screened [ Time Frame: School screening occurs once per school year, with timing and practices varying by school. ]
  • Proportion of children who receive follow-up [ 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. ]

Central Contacts and Locations

Central contacts

Susan Emmett, MD, MPH

501-603-1212sdemmett@uams.edu

Samantha Robler, AuD,PhD

907-434-0433skrobler@uams.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Matt Bush, MD, PhD

859-562-3120

More Information

Sponsor

University of Arkansas

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Rural
  • hearing
  • loss
  • telemedicine
  • telehealth
  • school
  • disparities
  • screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-05-06.