Testing a Smart Phone App to Enhance Voice Therapy Adherence

Study Overview
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Brief Summary
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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.

Official Title
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Testing a Smart Phone App to Enhance Voice Therapy Adherence

Conditions
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Voice Disorders

Intervention / Treatment
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* Behavioral: Traditional Voice therapy
* Behavioral: Voice Therapy App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Apple phone (iOS) Impaired hearing Uncontrolled asthma Smoking H/o vocal fold surgery Presence of vocal fold pathology Previous history of experience with VFE performance Non-English speaking participants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Voice Therapy<br>Standard of care (traditional) voice therapy. | Behavioral: Traditional Voice therapy<br>* Traditional method of voice therapy<br>* Other names: Vocal Function Exercises;|
| Experimental: App Group<br>Voice therapy using a smartphone app. | Behavioral: Voice Therapy App<br>* 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.<br>* Other names: Vocal Function Exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Number of completed home practice sessions | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPT (maximum phonation time) | Maximum phonation time | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence