Team-based Virtual Pediatric Cochlear Implant Clinic
- Conditions
- Hearing Loss
- Interventions
- Behavioral: Virtual team-based clinicBehavioral: Remote cochlear implant programming
- Registration Number
- NCT05030961
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Established Cochlear Implant Recipient Group Virtual team-based clinic Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year. Established Cochlear Implant Recipient Group Remote cochlear implant programming Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year. Pediatric Cochlear Implant Candidate Group Virtual team-based clinic 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.
- Primary Outcome Measures
Name Time Method Electrode Impedances Up to 1 year Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software
LittleEars questionnaire scores 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 Up to 1 year Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software
Threshold/Upper stimulation levels Up to 1 year As measured from the cochlear implant software
Auditory Skills Checklist (ASC) scores 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 Up to 1 year Datalogging, reported in hours per week, will be extracted from the cochlear implant software
- Secondary Outcome Measures
Name Time Method Patient Health Questionnaire version 8 (PHQ-8) scores Up to 1 year 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).
Behavior Assessment System for Children version 3 (BASC-3) scores Up to 1 year 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.
Parenting Stress Index/Short Form (PSI) scores Up to 1 year 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.
Generalized Anxiety Disorder version 7 (GAD-7) scores Up to 1 year 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 Up to 1 year 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 Up to 1 year 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
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores Up to 1 year 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.
Parenting Stress-CI scores Up to 1 year 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.
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States