Team-based Virtual Pediatric Cochlear Implant Clinic

University of Miami

Status: Completed

Conditions: Hearing Loss

Treatments: Behavioral: Remote cochlear implant programming; Behavioral: Virtual team-based clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT05030961

20210584

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Pediatric Cochlear Implant Candidate Group

Experimental group

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.

Treatment:

Behavioral: Virtual team-based clinic

Established Cochlear Implant Recipient Group

Experimental group

Description:

Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year.

Treatment:

Behavioral: Remote cochlear implant programming

Behavioral: Virtual team-based clinic