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Completed

NCT Number: NCT05030961

Team-based Virtual Pediatric Cochlear Implant Clinic

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.

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Key information

Age range

0 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual team-based clinic

Behavioral

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

Behavioral

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

Primary outcomes

  1. Electrode Impedances

    Time frame: Up to 1 year

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

  2. Electrically evoked compound potential values

    Time frame: Up to 1 year

    Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software

  3. Datalogging

    Time frame: Up to 1 year

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

  4. Threshold/Upper stimulation levels

    Time frame: Up to 1 year

    As measured from the cochlear implant software

  5. LittleEars questionnaire scores

    Time frame: 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.

  6. Auditory Skills Checklist (ASC) scores

    Time frame: Up to 1 year

    ASC has a Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills

Secondary outcomes

  1. Behavior Assessment System for Children version 3 (BASC-3) scores

    Time frame: 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.

  2. Patient Health Questionnaire version 8 (PHQ-8) scores

    Time frame: 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).

  3. Generalized Anxiety Disorder version 7 (GAD-7) scores

    Time frame: 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).

  4. Quality of Life- CI (QoL-CI) scores

    Time frame: Up to 1 year

    QoL-CI is scored 0-100 with higher scores indicating better quality of life.

  5. Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores

    Time frame: 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

  6. Parenting Stress Index/Short Form (PSI) scores

    Time frame: 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.

  7. Parenting Stress-CI scores

    Time frame: 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.

  8. Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Stanley J. Glaser Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2021
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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