Back to resultsTeam-based Virtual Pediatric Cochlear Implant Clinic
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual team-based clinic
Remote cochlear implant programming
Sponsored by
About this trial
This is an interventional health services research trial for Hearing Loss
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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pediatric Cochlear Implant Candidate Group
Established Cochlear Implant Recipient Group
Arm Description
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.
Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year.
Outcomes
Primary Outcome Measures
Electrode Impedances
Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software
Electrically evoked compound potential values
Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software
Datalogging
Datalogging, reported in hours per week, will be extracted from the cochlear implant software
Threshold/Upper stimulation levels
As measured from the cochlear implant software
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.
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
Secondary Outcome Measures
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.
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).
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).
Quality of Life- CI (QoL-CI) scores
QoL-CI is scored 0-100 with higher scores indicating better quality of life.
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
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.
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.
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.
Full Information
NCT ID
NCT05030961
First Posted
August 19, 2021
Last Updated
June 1, 2023
Sponsor
University of Miami
Collaborators
Stanley J. Glaser Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05030961
Brief Title
Team-based Virtual Pediatric Cochlear Implant Clinic
Official Title
Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Stanley J. Glaser Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pediatric Cochlear Implant Candidate Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Established Cochlear Implant Recipient Group
Arm Type
Experimental
Arm Description
Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year.
Intervention Type
Behavioral
Intervention Name(s)
Virtual team-based clinic
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Remote cochlear implant programming
Intervention Description
Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.
Primary Outcome Measure Information:
Title
Electrode Impedances
Description
Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software
Time Frame
Up to 1 year
Title
Electrically evoked compound potential values
Description
Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software
Time Frame
Up to 1 year
Title
Datalogging
Description
Datalogging, reported in hours per week, will be extracted from the cochlear implant software
Time Frame
Up to 1 year
Title
Threshold/Upper stimulation levels
Description
As measured from the cochlear implant software
Time Frame
Up to 1 year
Title
LittleEars questionnaire scores
Description
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
Title
Auditory Skills Checklist (ASC) scores
Description
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 Outcome Measure Information:
Title
Behavior Assessment System for Children version 3 (BASC-3) scores
Description
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.
Time Frame
Up to 1 year
Title
Patient Health Questionnaire version 8 (PHQ-8) scores
Description
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
Title
Generalized Anxiety Disorder version 7 (GAD-7) scores
Description
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
Title
Quality of Life- CI (QoL-CI) scores
Description
QoL-CI is scored 0-100 with higher scores indicating better quality of life.
Time Frame
Up to 1 year
Title
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores
Description
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
Title
Parenting Stress Index/Short Form (PSI) scores
Description
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
Title
Parenting Stress-CI scores
Description
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
Title
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chrisanda M Sanchez, AuD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Team-based Virtual Pediatric Cochlear Implant Clinic
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