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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Pennsylvania
      • West Chester, Pennsylvania, United States, 19383
        • Elizabeth Grillo

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Telepractice Global Voice Prevention Model
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.
Behavioral: In-person Global Voice Prevention Model
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.
Behavioral: Telepractice, Vocal Hygiene and Vocal Education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Question will be asked twice a day before and after teaching.
AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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.
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.
Quality of life questions.
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.
Vocal fatigue questions
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.
Perceptions of voice based on the Consensus-auditory Perceptual Evaluation of Voice.
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.
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.
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.
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.
AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Chester University of Pennsylvania

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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