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临床试验/NCT04002336
NCT04002336已完成不适用

Testing a Smart Phone App to Enhance Voice Therapy Adherence

Vrushali Angadi2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Adherence

研究概览

简要总结

The current project is designed as phase 1 study conducted to improve/enhance normal voice. Fifteen Thirty non-treatment seeking individuals, with no identifiable vocal pathology on laryngeal examination, will be randomized to one of two groups; 1) Voice therapy delivery without App (control/standard of care), 2) Voice therapy delivery with app (experimental). Participants in both groups will attend weekly voice therapy sessions (for 6 weeks) with the PI and Co- I (Joseph Stemple). Control group participants will be provided with an audio file of the exercises, and an exercise log sheet to track progress. Experimental group participants will use the smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track. Three-wave surveys will be conducted at the baseline, four weeks and 6 weeks after the intervention. Other data sources include study administration, exercise logs, app data, and clinical assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Single-blinded to primary outcome measure

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 years
  • Non-smokers
  • Hearing level within normal limits
  • Absence of vocal fold pathology as confirmed by MD on laryngeal examination
  • Agree to avoid vocally abusive behaviors for the entirety of the study

排除标准

  • Apple phone (iOS)
  • Impaired hearing
  • Uncontrolled asthma
  • H/o vocal fold surgery
  • Presence of vocal fold pathology
  • Previous history of experience with VFE performance
  • Non-English speaking participants

研究组 & 干预措施

Traditional Voice Therapy

Active Comparator

Standard of care (traditional) voice therapy.

干预措施: Traditional Voice therapy (Behavioral)

App Group

Experimental

Voice therapy using a smartphone app.

干预措施: Voice Therapy App (Behavioral)

结局指标

主要结局

Adherence

时间窗: 6 weeks

Number of completed home practice sessions

次要结局

  • MPT (maximum phonation time)(6 weeks)

研究者

发起方
Vrushali Angadi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vrushali Angadi

Assistant Professor

University of Kentucky

研究点 (2)

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