Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2021-11-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Pediatric Cochlear Implant Candidate Group
Participants who are in the process of receiving standard of care cochlear implant evaluation. Participants will receive a virtual team-based clinic as a part of the candidacy evaluation process for one year.
Virtual team-based clinic
Virtual team-based clinic will include consultation, counseling, and education from pediatric audiology, psychology, auditory verbal therapy, and education. Each session lasts approximately 30 minutes with a total of 3 sessions within the year.
Established Cochlear Implant Recipient Group
Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year.
Virtual team-based clinic
Virtual team-based clinic will include consultation, counseling, and education from pediatric audiology, psychology, auditory verbal therapy, and education. Each session lasts approximately 30 minutes with a total of 3 sessions within the year.
Remote cochlear implant programming
Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.
Interventions
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Virtual team-based clinic
Virtual team-based clinic will include consultation, counseling, and education from pediatric audiology, psychology, auditory verbal therapy, and education. Each session lasts approximately 30 minutes with a total of 3 sessions within the year.
Remote cochlear implant programming
Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.
Eligibility Criteria
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Inclusion Criteria
1. English speaking patients (parents can speak English and/or Spanish)
2. Ages 0-12 years who are cochlear implant candidates and undergoing the evaluation process
Established CI recipients:
1. English speaking patients (parents can speak English and/or Spanish)
2. Ages 1-12 with at least 6 months of CI experience with a company that has remote programming capacity
Exclusion Criteria
2. Patients who do not live in Florida
3. Patients who have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
0 Years
12 Years
ALL
No
Sponsors
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Stanley J. Glaser Foundation
UNKNOWN
University of Miami
OTHER
Responsible Party
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Chrisanda Sanchez
Assistant Professor
Principal Investigators
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Chrisanda M Sanchez, AuD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20210584
Identifier Type: -
Identifier Source: org_study_id
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