- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873130
Effectiveness of Telepractice by Smartphone App Technology in Preventing Voice Problems
September 8, 2020 updated by: Elizabeth Grillo, West Chester University of Pennsylvania
Voice disorders in teachers have a significant impact on communication, quality of life, and economic costs to the healthcare system.
We need to advance the prevention of voice disorders in teachers by testing an online telepractice model with synchronous (in real-time) and asynchronous (stored and accessed later) methods.
The current study will investigate the effectiveness of the theoretically-driven Global Voice Prevention Model (GVPM) delivered by two methods; 1) online telepractice (synchronous and asynchronous) and 2) traditional, in-person for vocally healthy physical education and vocal music student teachers.
Effectiveness of the model will be assessed by voice-related measures captured daily on a smartphone app during student teaching, matching the asynchronous aspects of the telepractice model and representing the effects of vocal loading from teaching.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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West Chester, Pennsylvania, United States, 19383
- Elizabeth Grillo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- senior at West Chester University as of fall 2016 and fall 2017,
- student teaching during spring 2017 or 2018,
- healthy voice user,
- owns a smartphone
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral: Telepractice Global Voice Prevention Model
Participants will complete the Global Voice Prevention Model (GVPM) through West Chester University's Desire 2 Learn (D2L) software program.
Synchronous and asynchronous learning opportunities are provided through D2L over a four week period.
The GVPM includes vocal hygiene, vocal education, and vocal training.
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|
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Experimental: Behavioral: In-person Global Voice Prevention Model
Participants will complete the Global Voice Prevention Model (GVPM) at West Chester University in-person.
The GVPM will meet for 2 hours once a week for four weeks.
The GVPM includes vocal hygiene, vocal education, and vocal training.
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|
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Sham Comparator: Behavioral: Telepractice, Vocal Hygiene and Vocal Education
Participants will complete Vocal Hygiene and Vocal Education through West Chester University's Desire 2 Learn (D2L) software program.
Asynchronous learning opportunities are provided through D2L over a one week period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence and frequency of a voice problem
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Question will be asked twice a day before and after teaching.
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AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acoustic: fundamental frequency
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
Participants will record sustained aaaahhh, we were away a year ago, and describe their voice for 15 seconds twice a day before and after teaching.
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AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
|
Acoustic: standard deviation of fundamental frequency
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
Participants will record sustained aaaahhh, we were away a year ago, and describe their voice for 15 seconds twice a day before and after teaching.
|
AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
|
Acoustic: jitter%
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
Participants will record sustained aaaahhh, we were away a year ago, and describe their voice for 15 seconds twice a day before and after teaching.
|
AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
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Acoustic: shimmer%
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
Participants will record sustained aaaahhh, we were away a year ago, and describe their voice for 15 seconds twice a day before and after teaching.
|
AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
|
Acoustic: cepstral peak prominence
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
Participants will record sustained aaaahhh, we were away a year ago, and describe their voice for 15 seconds twice a day before and after teaching.
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AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
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Perceptual: Voice Handicap Index
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Quality of life questions.
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AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Perceptual: Vocal Fatigue Index
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Vocal fatigue questions
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AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Perceptual: perceptions of voice
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Perceptions of voice based on the Consensus-auditory Perceptual Evaluation of Voice.
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AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Aerodynamic: sustained aaaaahhhhh
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Participants will say aaaaahhhh as long as they can to determine how well they are managing airflow with phonation twice a day before and after teaching.
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AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Aerodynamic: s/z ratio
Time Frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
|
Participants will say s and z as long as they can to determine how well they are managing airflow with phonation twice a day before and after teaching.
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AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
August 8, 2016
First Submitted That Met QC Criteria
August 15, 2016
First Posted (Estimate)
August 19, 2016
Study Record Updates
Last Update Posted (Actual)
September 10, 2020
Last Update Submitted That Met QC Criteria
September 8, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R15DC014566-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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