NCT03875339|CompletedResultsDMC
Communities Helping the Hearing of Infants by Reaching Parents
CHHIRP
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Sponsor study identifier
Secondary identifiers
interventional
2,699
1 country
2
Study Start
January 13, 2021
Actual (reported)Primary Completion
September 8, 2023
Actual (reported)Study Completion
September 8, 2023
Actual (reported)Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose the condition and many families are delayed in receiving this testing or never obtain the needed testing. This research employs a new method for helping children with hearing loss receive timely care by using a patient navigator, who is someone who teaches and provides emotional/social support for the families of these children. The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled appointments, and expand parental knowledge of pediatric hearing loss.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 8, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2019
Actual (reported)March 14, 2019
Actual (reported)January 13, 2021
Actual (reported)September 8, 2023
Actual (reported)September 8, 2023
Actual (reported)February 14, 2025
Actual (reported)Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)
Examination of adherence to follow-up with a navigator.
Examination of adherence to follow-up without a navigator.
Use of a dedicated Navigator to determine if follow-up and compliance rates can be improved for those infants initially demonstrating an abnormal hearing result.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Kentucky
Lexington, Kentucky, 40536, United States
Office for Children with Special Health Care Needs
Louisville, Kentucky, 40222, United States
Bush M, Hatfield M, Schuh M, Balasuriya B, Mahairas A, Jacobs J, Studts C, Westgate P, Schoenberg N, Shinn J, Creel L. Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP) through patient navigation: a hybrid implementation effectiveness stepped wedge trial protocol. BMJ Open. 2022 Apr 19;12(4):e054548. doi: 10.1136/bmjopen-2021-054548.
Matthew L Bush, MD, PhD
Associate Professor, Vice Chair of Research
2,699 participants (actual enrollment reported by the registry).
First Submitted
March 8, 2019
First Posted
March 14, 2019
Study Start
January 13, 2021
Actual (reported)Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss
Contact the study team to confirm eligibility.
Primary Completion
September 8, 2023
Actual (reported)Study Completion
September 8, 2023
Actual (reported)Last Updated
February 14, 2025
Results First Posted
February 14, 2025
Record last verified: 2025-01
De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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