Prevention of Voice Disorders in Student TeachersNCT02873130
Effectiveness of Telepractice by Smartphone App Technology in Preventing Voice Problems
A study testing Telepractice Global Voice Prevention Model, In-person Global Voice Prevention Model and Telepractice, Vocal Hygiene and Vocal Education in people with Prevention of Voice Disorders in Student Teachers, run by West Chester University of Pennsylvania at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Voice Disorders in Student Teachers
- What is being tested?
- Telepractice Global Voice Prevention Model, In-person Global Voice Prevention Model and Telepractice, Vocal Hygiene and Vocal Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Telepractice Global Voice Prevention Model, In-person Global Voice Prevention Model, Telepractice, Vocal Hygiene and Vocal Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepractice Global Voice Prevention ModelBehavioural
In-person Global Voice Prevention ModelBehavioural
Telepractice, Vocal Hygiene and Vocal EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Telepractice Global Voice Prevention Model | Experimental | 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. Receives: Behavioral: Telepractice Global Voice Prevention Model |
| Behavioral: In-person Global Voice Prevention Model | Experimental | 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. Receives: Behavioral: In-person Global Voice Prevention Model |
| Behavioral: Telepractice, Vocal Hygiene and Vocal Education | Sham comparator | 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. Receives: Behavioral: Telepractice, Vocal Hygiene and Vocal Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and frequency of a voice problem
Question will be asked twice a day before and after teaching.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Secondary outcomes (10)
Acoustic: fundamental frequency
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.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Acoustic: standard deviation of fundamental frequency
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.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Acoustic: jitter%
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.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Acoustic: shimmer%
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.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Acoustic: cepstral peak prominence
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.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Perceptual: Voice Handicap Index
Quality of life questions.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Perceptual: Vocal Fatigue Index
Vocal fatigue questions
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Perceptual: perceptions of voice
Perceptions of voice based on the Consensus-auditory Perceptual Evaluation of Voice.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Aerodynamic: sustained aaaaahhhhh
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.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Aerodynamic: s/z ratio
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.
Measured: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Voice Disorders in Student TeachersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Chester University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Grillo, West Chester University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873130
- Sponsor's protocol ID
- 1R15DC014566-01
- Status last verified
- Sep 2020
- First submitted
- 8 Aug 2016
- Last updated
- 10 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telepractice by Smartphone App Technology in Preventing Voice Problems
- ClinicalTrials.gov ID
- NCT02873130
- Acronym / sponsor ID
- 1R15DC014566-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- West Chester University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Telepractice Global Voice Prevention Model | Experimental | Behavioral: Telepractice Global Voice Prevention ModelParticipants 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. |
| Behavioral: In-person Global Voice Prevention Model | Experimental | Behavioral: In-person Global Voice Prevention ModelParticipants 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. |
| Behavioral: Telepractice, Vocal Hygiene and Vocal Education | Sham comparator | Behavioral: Telepractice, Vocal Hygiene and Vocal EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telepractice Global Voice Prevention Model | Behavioural | Behavioral: Telepractice Global Voice Prevention Model |
| In-person Global Voice Prevention Model | Behavioural | Behavioral: In-person Global Voice Prevention Model |
| Telepractice, Vocal Hygiene and Vocal Education | Behavioural | Behavioral: Telepractice, Vocal Hygiene and Vocal Education |
Primary outcome
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.
Question will be asked twice a day before and after teaching.
10 secondary outcomes
Acoustic: fundamental frequency
Time frame: 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.
Acoustic: jitter%
Time frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Acoustic: shimmer%
Time frame: 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.
Perceptual: Voice Handicap Index
Time frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Perceptual: Vocal Fatigue Index
Time frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Perceptual: perceptions of voice
Time frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Aerodynamic: sustained aaaaahhhhh
Time frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Aerodynamic: s/z ratio
Time frame: AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepractice Global Voice Prevention Model, In-person Global Voice Prevention Model and Telepractice, Vocal Hygiene and Vocal Education in people with Prevention of Voice Disorders in Student Teachers, run by West Chester University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.