Testing a Smart Phone App to Enhance Voice Therapy Adherence
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
- 是
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
Standard of care (traditional) voice therapy.
干预措施: Traditional Voice therapy (Behavioral)
App Group
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
Vrushali Angadi
Assistant Professor
University of Kentucky
