Team-based Virtual Pediatric Cochlear Implant Clinic

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030961
• Other study ID #: 20210584
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Stanley J. Glaser Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrode Impedances	Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software	Up to 1 year
Primary	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
Primary	Datalogging	Datalogging, reported in hours per week, will be extracted from the cochlear implant software	Up to 1 year
Primary	Threshold/Upper stimulation levels	As measured from the cochlear implant software	Up to 1 year
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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