Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

NCT ID: NCT02497690

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2019-12-09

Brief Summary

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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

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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.

Conditions

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Congenital Sensorineural Deafness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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In-person ART

In-person approach to provide ART.

Group Type ACTIVE_COMPARATOR

In-person ART

Intervention Type BEHAVIORAL

Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.

Telehealth ART

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

Group Type EXPERIMENTAL

Telemedicine

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

In-person ART

Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.

Intervention Type BEHAVIORAL

Other Intervention Names

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Telehealth Standard of Care

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Colorado, Boulder

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Grigsby, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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5U01DC013529

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-1103

Identifier Type: -

Identifier Source: org_study_id

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