Effectiveness of Therapy Via Telemedicine Following Cochlear Implants (TACIT)

January 14, 2021 updated by: University of Colorado, Denver
This study will assess the effectiveness of post-cochlear implant or hearing aid fitting Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: In-person ART
In-person approach to provide ART.
Behavioral: In-person ART
Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.
Other Names:
  • Standard of Care
Experimental: Telehealth ART
Telemedicine technology approach (e.g. interactive video) to provide ART.
Behavioral: Telemedicine
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.
Other Names:
  • Telehealth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of subjects' language abilities.
Time Frame: 6 months
Evaluation of subjects' language abilities will be conducted using the 5th Edition of the Preschool Language scales Preschool Language Scale (PLS-5)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Colorado, Boulder

Investigators

  • Principal Investigator: James Grigsby, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

December 9, 2019

Study Completion (Actual)

December 9, 2019

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1103
  • 5U01DC013529 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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