Team-based Virtual Pediatric Cochlear Implant Clinic
Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants
1 other identifier
interventional
86
1 country
1
Brief Summary
The purpose of this study is to see if remote visits for pediatric cochlear implant patients are possible. The investigator will be assessing whether a multi-disciplinary team approach can be achieved remotely for patients both undergoing the cochlear implant (CI) process and for those who have already been implanted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2021
CompletedFirst Posted
Study publicly available on registry
September 1, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 2, 2023
June 1, 2023
1.6 years
August 19, 2021
June 1, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Electrode Impedances
Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software
Up to 1 year
Electrically evoked compound potential values
Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software
Up to 1 year
Datalogging
Datalogging, reported in hours per week, will be extracted from the cochlear implant software
Up to 1 year
Threshold/Upper stimulation levels
As measured from the cochlear implant software
Up to 1 year
LittleEars questionnaire scores
The LittleEars auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance.
Up to 1 year
Auditory Skills Checklist (ASC) scores
ASC has a Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills
Up to 1 year
Secondary Outcomes (8)
Behavior Assessment System for Children version 3 (BASC-3) scores
Up to 1 year
Patient Health Questionnaire version 8 (PHQ-8) scores
Up to 1 year
Generalized Anxiety Disorder version 7 (GAD-7) scores
Up to 1 year
Quality of Life- CI (QoL-CI) scores
Up to 1 year
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores
Up to 1 year
- +3 more secondary outcomes
Study Arms (2)
Pediatric Cochlear Implant Candidate Group
EXPERIMENTALParticipants 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.
Established Cochlear Implant Recipient Group
EXPERIMENTALParticipants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year.
Interventions
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 will be provided via Zoom on a study-provided encrypted laptop.
Eligibility Criteria
You may qualify if:
- New patients undergoing CI evaluation:
- English speaking patients (parents can speak English and/or Spanish)
- Ages 0-12 years who are cochlear implant candidates and undergoing the evaluation process
- Established CI recipients:
- English speaking patients (parents can speak English and/or Spanish)
- Ages 1-12 with at least 6 months of CI experience with a company that has remote programming capacity
You may not qualify if:
- Patients with families who speak languages other than English or Spanish
- Patients who do not live in Florida
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Stanley J. Glaser Foundationcollaborator
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chrisanda M Sanchez, AuD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 19, 2021
First Posted
September 1, 2021
Study Start
November 1, 2021
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
June 2, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share