Team-based Virtual Pediatric Cochlear Implant Clinic

Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Behavioral: Virtual team-based clinic; Behavioral: Remote cochlear implant programming

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Sarangoulis; Phone Number: 305-243-8397; Email: cmd247@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

New patients undergoing CI evaluation:

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:

1. Patients with families who speak languages other than English or Spanish
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.; Behavioral: Remote cochlear implant programming; Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior Assessment System for Children version 3 (BASC-3) scores	BASC-3 is scored 0-120 as a T score. Any scores between 60-70 is considered at risk / requires monitoring and scores greater than 70 are considered clinically significant / an area that likely requires therapeutic intervention.	Up to 1 year
Patient Health Questionnaire version 8 (PHQ-8) scores	PHQ-8 has 8 items rated on a scale from "not at all" (0) to "nearly every day" (3), with higher scores indicating greater frequency of depressive symptoms. The sum of the items indicates the overall level of depressive symptoms indicating mild (5-9), moderate (10-14), moderately severe (15-19), and severe depressive symptoms (20- 24).	Up to 1 year
Generalized Anxiety Disorder version 7 (GAD-7) scores	GAD-7 is a 7-item self-report questionnaire of anxiety symptomatology in the past 14 days. Respondents rate the frequency of each item during the past two weeks on a 0-3-point scale ranging from not at all (0) to nearly every day (3). The sum of the items indicates the overall level of anxiety symptoms indicating mild (0-4), moderate (5-9), moderately severe (10-14), and severe (15- 21).	Up to 1 year
Quality of Life- CI (QoL-CI) scores	QoL-CI is scored 0-100 with higher scores indicating better quality of life.	Up to 1 year
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores	CIQOL-35 Profile is a 35 item questionnaire with a total score ranging from 0-100% with a higher score indicating a higher level of functional ability with a cochlear implant	Up to 1 year
Parenting Stress Index/Short Form (PSI) scores	Parenting Stress Index/Short Form (PSI) contains 36 items rated on a 6-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree) and a total score. Higher scores indicate increased parenting stress.	Up to 1 year
Parenting Stress-CI scores	Parenting Stress-CI is completed by the parent and scored from "not at all stressful" (0) to "very stressful" (3) with higher scores indicating greater degrees of parenting stress. For parents of children 0-5 years, there are 15 items. For parents of children 6-12 years there are 8 items.	Up to 1 year
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores	The SPISE-R is comprised of 46 questions that uses a 7-point Likert scale to query parents' beliefs, knowledge, confidence, and actions relevant to supporting their child's auditory access and spoken language development. The total average score will range from 1 to 7 with 7 indicating the highest score / highest level of parental involvement and self efficacy.	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Stanley J. Glaser Foundation
• Investigators: Principal Investigator: Chrisanda M Sanchez, AuD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 20210584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No