NCT01917747|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
NIH
NIH
interventional
106
1 country
2
Study Start
January 1, 2014
Actual (reported)Primary Completion
September 30, 2018
Actual (reported)Study Completion
January 1, 2020
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.
January 1, 2020
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.
August 2, 2013
Actual (reported)August 7, 2013
Actual (reported)January 1, 2014
Actual (reported)September 30, 2018
Actual (reported)December 24, 2019
Actual (reported)January 1, 2020
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 for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
3 months after birth
Number of Participants Who do Not Receive Hearing Intervention by Six Months of Age (Aim 2)
This outcome is the number of participants who do not follow-up for therapeutic audiological intervention after a diagnosis of infant hearing loss is made from the date of randomization to 6 months after birth.
From the date of hearing loss diagnosis up to 6 months after birth
Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1)
From date of randomization to first audiological diagnostic test up to 12 months of age
Number of Weeks Between Date of Hearing Loss Diagnosis and Intervention (Aim 2)
From the date of hearing loss diagnosis until up to one year
The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice.
The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed.
The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing loss is imparted.
University of Kentucky
Lexington, Kentucky, 40536, United States
Commission for Children with Special Health Care Needs
Louisville, Kentucky, 40222, United States
Matthew L Bush, MD
University of Kentucky
106 participants (actual enrollment reported by the registry).
First Submitted
August 2, 2013
First Posted
August 7, 2013
Study Start
January 1, 2014
Actual (reported)Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach
The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test, as is standard practice.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2018
Actual (reported)Study Completion
January 1, 2020
Actual (reported)Last Updated
March 31, 2020
Results First Posted
December 24, 2019
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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