Team-based Virtual Pediatric Cochlear Implant Clinic

University of Miami86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Hearing Loss

Interventions

Virtual team-based clinicBEHAVIORAL

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 programmingBEHAVIORAL

Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Electrode Impedances

Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software

Time frame: 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

Time frame: Up to 1 year

Datalogging

Datalogging, reported in hours per week, will be extracted from the cochlear implant software

Time frame: Up to 1 year

Threshold/Upper stimulation levels

As measured from the cochlear implant software

Time frame: 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.

Time frame: 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

Time frame: Up to 1 year

Secondary Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 1 year