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Effectiveness of Therapy Via Telemedicine Following Cochlear Implants (TACIT)

Primary Purpose

Congenital Sensorineural Deafness

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
In-person ART
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Congenital Sensorineural Deafness focused on measuring Cochlear Implant, Hearing Aid, Telemedicine

Eligibility Criteria

6 Months - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-person ART

Telehealth ART

Arm Description

In-person approach to provide ART.

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

Outcomes

Primary Outcome Measures

Evaluation of subjects' language abilities.
Evaluation of subjects' language abilities will be conducted using the 5th Edition of the Preschool Language scales Preschool Language Scale (PLS-5)

Secondary Outcome Measures

Full Information

First Posted
May 29, 2015
Last Updated
January 14, 2021
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT02497690
Brief Title
Effectiveness of Therapy Via Telemedicine Following Cochlear Implants
Acronym
TACIT
Official Title
Effectiveness of Therapy Via Telemedicine Following Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), University of Colorado, Boulder

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Sensorineural Deafness
Keywords
Cochlear Implant, Hearing Aid, Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-person ART
Arm Type
Active Comparator
Arm Description
In-person approach to provide ART.
Arm Title
Telehealth ART
Arm Type
Experimental
Arm Description
Telemedicine technology approach (e.g. interactive video) to provide ART.
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine
Other Intervention Name(s)
Telehealth
Intervention Description
Half of subjects will undergo six months of ART administered via telehealth. Therapy will be provided in the usual manner, except a computer will be used to facilitate the interaction.
Intervention Type
Behavioral
Intervention Name(s)
In-person ART
Other Intervention Name(s)
Standard of Care
Intervention Description
Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.
Primary Outcome Measure Information:
Title
Evaluation of subjects' language abilities.
Description
Evaluation of subjects' language abilities will be conducted using the 5th Edition of the Preschool Language scales Preschool Language Scale (PLS-5)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Grigsby, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

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