Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05513833
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2022-08-14
Brief Title:
School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Appalachian Specialty Telemedicine Access for Referrals STAR Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Childhood hearing loss has substantial lifelong consequences including speech-language delay worse academic performance and limited vocational opportunities In rural settings where access to care is limited school-based preventative screening programs can help in early identification of childhood hearing loss The state of Kentucky mandates hearing screening for all schools however the effectiveness of these programs is unclear Further current school programs do not include a middle ear assessment which is needed to detect infection-related hearing loss common in children in rural and low-income settings In children referred from school-based hearing screening programs loss to follow-up also remains a pervasive issue
To address these key issues the University of Kentucky has partnered with the University of Arkansas Medical Sciences to lead the Appalachian STAR trial 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
The Appalachian STAR stepped-wedge cluster randomized trial will be conducted in approximately 64 elementary schools located in 14 counties in rural Kentucky Approximately 3600 students at school entry will be enrolled annually for 4 years for a total of approximately 14400 children Cluster randomization will occur in two sequences at the county level with 7 counties clusters in each sequence The 4-year trial will include a control condition period followed by phased roll-out of the intervention The enhanced mHealth school hearing screening protocol will be implemented first The following year specialty telemedicine referral will be added to the enhanced screening protocol All 14 counties will receive the STAR model by the end of the trial An implementation evaluation will be conducted to refine the STAR model throughout the trial If successful the STAR model could be applied to address hearing loss and other childhood health conditions that affect underserved rural communities across America
To address these key issues the University of Kentucky has partnered with the University of Arkansas Medical Sciences to lead the Appalachian STAR trial 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
The Appalachian STAR stepped-wedge cluster randomized trial will be conducted in approximately 64 elementary schools located in 14 counties in rural Kentucky Approximately 3600 students at school entry will be enrolled annually for 4 years for a total of approximately 14400 children Cluster randomization will occur in two sequences at the county level with 7 counties clusters in each sequence The 4-year trial will include a control condition period followed by phased roll-out of the intervention The enhanced mHealth school hearing screening protocol will be implemented first The following year specialty telemedicine referral will be added to the enhanced screening protocol All 14 counties will receive the STAR model by the end of the trial An implementation evaluation will be conducted to refine the STAR model throughout the trial If successful the STAR model could be applied to address hearing loss and other childhood health conditions that affect underserved rural communities across America
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01OD033247 | NIH | None | httpsreporternihgovquickSearch1U01OD033247 |