Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- University of Miami
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Electrode Impedances
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Chrisanda Sanchez
Assistant Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Electrode Impedances
Time Frame: Up to 1 year
Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software
LittleEars questionnaire scores
Time Frame: Up to 1 year
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.
Electrically evoked compound potential values
Time Frame: Up to 1 year
Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software
Threshold/Upper stimulation levels
Time Frame: Up to 1 year
As measured from the cochlear implant software
Auditory Skills Checklist (ASC) scores
Time Frame: Up to 1 year
ASC has a Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills
Datalogging
Time Frame: Up to 1 year
Datalogging, reported in hours per week, will be extracted from the cochlear implant software
Secondary Outcomes
- Patient Health Questionnaire version 8 (PHQ-8) scores(Up to 1 year)
- Behavior Assessment System for Children version 3 (BASC-3) scores(Up to 1 year)
- Parenting Stress Index/Short Form (PSI) 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)
- Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores(Up to 1 year)
- Parenting Stress-CI scores(Up to 1 year)