NCT02684175

Brief Summary

The objective of this study is to compare remote and in-person audiological cochlear implant candidacy evaluations (including audiological (hearing) testing and counseling sessions) in a rural Appalachian region.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2017

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

February 6, 2016

Last Update Submit

February 11, 2020

Conditions

Hearing LossHearing Disorders

Keywords

AudiometryCochlear ImplantsAdultTelemedicineHealth Services AccessibilityRural PopulationTechnology Assessment, Biomedical

Outcome Measures

Primary Outcomes (7)

  • (Aim 1): Comparison of Remote Audiological Testing Scores with In-Person Audiological Testing Scores

    Arizona Biological (AzBio) scores gathered remotely via the telemedicine system will be compared to AzBio scores gathered via in-person (face-to-face) per participant.

    2 weeks

  • (Aim 2): Remote Cochlear Implant Counseling Completion Rate

    The number of participants that enroll into Aim 2 will be recorded and compared to the number of participants that complete all study-related activities within this Aim.

    45 minutes

  • (Aim 2): In-Person Cochlear Implant Counseling Participant Feedback

    Participants in Aim 2 that receive an in-person session will complete a 6-question satisfaction questionnaire post cochlear implant counseling session.

    10 minutes

  • (Aim 2): In-Person Cochlear Implant Counseling Provider Feedback

    Provider(s) in Aim 2 that deliver in-person session(s) will complete a 6-question satisfaction questionnaire post cochlear implant counseling session.

    10 minutes

  • (Aim 2): Remote Cochlear Implant Counseling Participant Feedback

    Participants in Aim 2 that receive a remote session will complete a 13-question satisfaction questionnaire post cochlear implant counseling session.

    10 minutes

  • (Aim 2): Remote Cochlear Implant Counseling Provider Feedback

    Provider(s) in Aim 2 that deliver remote session(s) will complete a 13-question satisfaction questionnaire post cochlear implant counseling session.

    10 minutes

  • (Aim 2): Stage of Change toward Seeking Hearing Rehabilitation

    Participants in Aim 2 will complete the University of Rhode Island (URICA) questionnaire post cochlear implant counseling session. This questionnaire will determine the participant's stage of change toward seeking hearing rehabilitation. These URICA scores will be compared to URICA scores gathered in Aim 1 for each participant.

    2-4 weeks

Study Arms (2)

In-Person CI Counseling Session

ACTIVE COMPARATOR

Participants (n=6) randomized to receive an in-person CI counseling session will receive what normally occurs with patients pursuing cochlear implantation. The counseling will last 30-45 minutes and consists 5 key components: an explanation of the patient's hearing testing results, a discussion of the impact of hearing loss on the patient's life, treatment options for hearing loss including hearing aid amplification and cochlear implantation, an explanation of how CIs function and the necessary steps in candidacy and rehabilitation, and an outline of the expected outcomes following cochlear implantation.

Other: In-Person CI Counseling

Remote CI Counseling Session

EXPERIMENTAL

Participants (n=6) randomized to receive a remote CI counseling session will be receiving the counseling session remotely. The participants will be counseled remotely by the audiologist located in Lexington, KY via the telemedicine system (intervention). This counseling will last 30-45 minutes and consists 5 key components: an explanation of the patient's hearing testing results, a discussion of the impact of hearing loss on the patient's life, treatment options for hearing loss including hearing aid amplification and cochlear implantation, explanation of how CIs function and the necessary steps in candidacy and rehabilitation, and an outline of the expected outcomes following cochlear implantation.

Device: Remote CI Counseling

Interventions

Remote CI CounselingDEVICE

The remote setup includes a 500 series teleconference audio and video live set-up. The teleconference set-up will be situated on a telemedicine cart and placed within the sound-proof booth at the testing site (UK ENT practice in Morehead, KY). The audiologist will deliver the session remotely.

Also known as: Polycom 500 series
Remote CI Counseling Session
In-Person CI CounselingOTHER

The standard face-to-face counseling that will occur between the participant and audiologist is the standard of care. No technology will be used. The audiologist will deliver the session face-to-face with the participant in the same room (standard practice).

In-Person CI Counseling Session

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (\>18) who are current patients at the University of Kentucky Morehead Clinic
  • Adults who have moderate to profound hearing loss
  • Adults who can speak and understand English since cochlear implantation candidacy testing is performed using standardized word lists in English

You may not qualify if:

  • Adults with prelingual deafness
  • Adults who use sign language as a primary means of communication
  • Adults with active otological infections with otorrhea or cerumen impaction seen on otoscopy
  • Pregnant women since pregnant women are not cochlear implant surgical candidates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (2)

  • Laplante-Levesque A, Hickson L, Worrall L. Stages of change in adults with acquired hearing impairment seeking help for the first time: application of the transtheoretical model in audiologic rehabilitation. Ear Hear. 2013 Jul-Aug;34(4):447-57. doi: 10.1097/AUD.0b013e3182772c49.

    PMID: 23364333BACKGROUND

  • Fletcher KT, Dicken FW, Adkins MM, Cline TA, McNulty BN, Shinn JB, Bush ML. Audiology Telemedicine Evaluations: Potential Expanded Applications. Otolaryngol Head Neck Surg. 2019 Jul;161(1):63-66. doi: 10.1177/0194599819835541. Epub 2019 Mar 5.

    PMID: 30832542RESULT

MeSH Terms

Conditions

Hearing LossHearing Disorders

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew L Bush, MD

    University of Kentucky Department of Otolaryngology - Head & Neck Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2016

First Posted

February 17, 2016

Study Start

January 1, 2016

Primary Completion

December 10, 2017

Study Completion

December 10, 2017

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)