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OpenTrials
Completed

NCT Number: NCT03309553

Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes Mobile Health and Telemedicine

Hearing loss is a common health problem in Alaska. Up to 75% of children growing up in Alaskan villages experience frequent ear infections, one of the major treatable causes of hearing loss. Children with even mild hearing loss face many challenges. These children often experience speech and language delays and have trouble in school. Teens with hearing loss are more likely to drop out of school, and are at risk for having difficulty finding jobs as adults. Promptly diagnosing and treating hearing loss is important for preventing these consequences. Alaska mandates school-based hearing screening, but many children with hearing loss are not identified by the current screening protocol, and most who are referred never make it into the healthcare system for diagnosis and treatment.

Alaska has already developed innovative strategies to address hearing loss. A network of village health clinics staffed by community health aides provide local care, and telemedicine has been adopted in over 250 village clinics statewide. Despite being widely available, telemedicine has not yet been used in school hearing screenings to speed up the referral process.

Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to explore whether a new school screening and referral process that incorporates mobile, or mHealth, screening and telemedicine referral will reduce childhood hearing loss disparities in the Norton Sound region. Children from kindergarten through 12th grade in 15 Norton Sound villages will receive the current school screening protocol and the new mHealth screen. Villages will then be randomized to continue the current primary care referral process or to adopt telemedicine referral for school screenings. The investigators hypothesize that the new mHealth screening protocol will identify more children with hearing loss, and telemedicine referral will reduce time to diagnosis. By better identifying hearing loss and speeding up diagnosis and treatment, the investigators expect the burden of childhood hearing loss to drop, hearing-related quality of life to improve, and school performance to improve in villages with telemedicine referral compared to current primary care referral villages. If the study shows these positive effects, mHealth screening and the telemedicine referral process could be implemented in school districts across the state of Alaska to reducing childhood hearing loss disparities statewide.

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Key information

Age range

4 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norton Sound Health Corporation

Nome, Alaska, 99762, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Student of the Bering Strait School District (BSSD) in Alaska
  • All school-aged children, from Kindergarten through 12th grade in the school district are eligible to participate
  • Parental signed consent to undergo routine hearing screening in the school setting
  • Verbal assent from children enrolled in the study

Exclusion criteria

  • Not a student of the Bering Strait School District
  • Parental consent for routine hearing screening not obtained
  • Verbal assent not obtained

Treatment and study plan

Current Primary Care Referral Process

Other

Children who screen positive for hearing loss will receive the same method each school had been using previously. This process involves a letter home to the parents, either sent with the child or by mail, requesting that the parent/caregiver bring the child to village health clinic for an evaluation.

Telemedicine Referral Process

Other

In villages randomized to the expedited telemedicine intervention, parents of children who screen positive will receive a phone call from the school or the clinic on the day of screening notifying them of the day and time of their child's telemedicine consultation appointment. Appointments will be made same-day or next-day, with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children screening positive will be transported to clinic for their appointment with adult chaperones. Parents are encouraged but not required to attend, except for children grades 2 and younger, for whom parental participation will be required. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.

Primary outcomes

  1. Time to diagnosis

    Time frame: From date of screening to date of ICD-10 ear/hearing diagnosis, measured in days, up to 9 months from date of screening in Year 1 and Year 2

    Comparing time to International Classification of Disease, Tenth Edition (ICD-10) ear/hearing diagnosis from date of screening between intervention and active comparator

Secondary outcomes

  1. Change in prevalence of hearing loss

    Time frame: Annual audiometric assessment at Year 1 and Year 2

    Based on audiometric assessment criteria, compared between intervention and active comparator

  2. Change in hearing-related quality of life

    Time frame: Annual questionnaire assessment at Year 1 and Year 2

    Measured using Hearing Environments and Reflection on Quality of Life (HEAR-QL) questionnaire, compared between intervention and active comparator

  3. Change in school performance

    Time frame: 3 times annually in Year 1 and Year 2

    Measure of math and reading performance using AIMSweb, compared between intervention and active comparator

Other outcomes

  1. Sensitivity and specificity of screening protocols

    Time frame: Cross-sectional comparison of concurrent mHealth screening protocol and current school hearing screening protocol to audiometric assessment, measured once at Year 1, all communities combined

    School and mobile health (mHealth) screening to audiometric assessment, all measured on the same day in Baseline at Year 1 before intervention

  2. Prevalence of hearing loss

    Time frame: Baseline at Year 1 before intervention

    Estimating baseline prevalence of hearing loss in school-aged children using audiometric assessments, all communities combined

Sponsors and collaborators

Lead sponsor

Norton Sound Health Corporation

Other

Collaborators

  • Duke University
  • Johns Hopkins University
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Hearing Norton Sound: A Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 13, 2017
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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