Effectiveness of Therapy Via Telemedicine Following Cochlear Implants (TACIT)

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Congenital Sensorineural Deafness

Treatments: Behavioral: Telemedicine; Behavioral: In-person ART

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02497690

5U01DC013529 (U.S. NIH Grant/Contract)

12-1103

Details and patient eligibility

About

This study will assess the effectiveness of post-cochlear implant or hearing aid fitting Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.

Full description

Children with congenital sensorineural deafness can acquire relatively normal language if they undergo cochlear implantation surgery or hearing aid fitting followed by aural rehabilitation therapy in the first three to four years of life. High quality therapy, however, may not be available in many areas. This study will assess the effectiveness of post-cochlear implant or hearing aid fitting ART delivered by means of telemedicine technology. This will be accomplished primarily by evaluating subjects' language abilities using the 5th Edition of the Preschool Language Scales.

Enrollment: 77 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• been fitted with bilateral or unilateral cochlear implants, or bilateral hearing aids.
• focus on recruiting families who are members of minority groups.
• therapy must be provided in English.

Exclusion criteria

• the presence of one or more significant co-morbidities

  • blindness,
  • severe motor impairment,
  • autism,
  • significant genetic/chromosomal syndrome.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 2 patient groups

In-person ART

Active Comparator group

Description:

In-person approach to provide ART.

Treatment:

Behavioral: In-person ART

Telehealth ART

Experimental group

Description:

Telemedicine technology approach (e.g. interactive video) to provide ART.

Treatment:

Behavioral: Telemedicine