NCT05593484 School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska
| NCT ID | NCT05593484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arkansas |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 8,060 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 8,060 participants in total. It began in 2023-09-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments. We will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school. This stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \~2,015 K-12 students/year). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years. Timeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. Now the STAR intervention will be rolled out in 2025-2026 for sequence 1 and 2026-2027 for sequence 2.
Eligibility Criteria
Inclusion Criteria: * Enrolled in one of the participating schools in the 3 regions * Children from grades (K-12) that are typically screened within participating schools * Eligible regardless of age, gender, race, or ethnicity Exclusion Criteria: N/A
Contact & Investigator
Matthew Hirschfeld, MD,PhD
PRINCIPAL INVESTIGATOR
Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical Center
Frequently Asked Questions
Who can join the NCT05593484 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 21 Years, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05593484 currently recruiting?
Yes, NCT05593484 is actively recruiting participants. Contact the research team at sdemmett@uams.edu for enrollment information.
Where is the NCT05593484 trial being conducted?
This trial is being conducted at Anchorage, United States.
Who is sponsoring the NCT05593484 clinical trial?
NCT05593484 is sponsored by University of Arkansas. The principal investigator is Matthew Hirschfeld, MD,PhD at Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical Center. The trial plans to enroll 8,060 participants.