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临床试验/NCT02684175
NCT02684175已完成不适用

Comparison of Patient & Provider Outcomes With In-Person Versus Remote Cochlear Implant Candidacy Evaluations

Matthew Bush, MD2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
(Aim 2): Stage of Change toward Seeking Hearing Rehabilitation

研究概览

简要总结

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.

详细描述

In Aim 1, participants (N=42) will receive both an in-person (standard of care) and remote (experimental) comprehensive audiological evaluation.Participants will be randomized to receive both sessions in a particular sequence (in-person, remote versus remote, in-person) to reduce order effect. Remote audiological sessions will involve face-to-face communication and testing over a high-speed hard wired connection (10 Mgb/s) conducted within the University of Kentucky firewall protection using a Polycom 500 series teleconference audio and live video set-up. The audiologist will direct the remote audiological evaluation with the participant (in the UK Otolaryngology (ENT) practice in Morehead, KY) from a work station at the Otolaryngology (ENT) practice in Lexington, KY. Evaluations will include pure-tone air and bone conduction thresholds (level of hearing ability) along with speech audiometry (speech recognition thresholds and word recognition scores). Scores from the Arizona Biological (AzBio) test (speech recognition) completed remotely and in-person will be compared for each person to determine equivalence. Upon enrollment, participants will fill out a demographic questionnaire along with an adapted version of the University of Rhode Island Change Assessment (URICA) questionnaire, assessing their current stage of change toward seeking hearing rehabilitation.

Aim 2 will involve participants from Aim 1 (N=12). Half of the cohort (n=6) will be randomized to receive a remote cochlear implant counseling session (experimental) and the other half (n=6) will be randomized to receive an in-person cochlear implant counseling session (standard of care). Both sessions will occur in the ENT practice in Morehead, KY with an audiologist but the audiologist will be physically located in the ENT practice in Lexington, KY directing the session during the remote sessions. The counseling session lasts 30-45 minutes and consists of 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 cochlear implants function and the necessary steps in candidacy and rehabilitation, and an outline of the expected outcomes following cochlear implantation. After participants receive either remote or in-person session, they will complete a satisfaction questionnaire on the session and the URICA questionnaire.The URICA questionnaire is a validated assessment tool measuring an individuals' motivation for change by providing a score that places them within one of the four categories: precontemplation, contemplation, action and maintenance (Laplante-Lavesque, Hickson, & Worral, 2013). After each session, the audiologist will fill out a satisfaction questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 2-4 weeks

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.

(Aim 2): Remote Cochlear Implant Counseling Provider Feedback

时间窗: 10 minutes

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

(Aim 2): Remote Cochlear Implant Counseling Participant Feedback

时间窗: 10 minutes

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

(Aim 2): Remote Cochlear Implant Counseling Completion Rate

时间窗: 45 minutes

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.

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

时间窗: 10 minutes

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

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

时间窗: 10 minutes

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

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

时间窗: 2 weeks

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.

次要结局

未报告次要终点

研究者

发起方
Matthew Bush, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew Bush, MD

Assistant Professor

University of Kentucky

研究点 (2)

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