NCT02873130

Brief 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) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

3.8 years

First QC Date

August 8, 2016

Last Update Submit

September 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence and frequency of a voice problem

    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 Outcomes (10)

  • Acoustic: fundamental frequency

    AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.

  • Acoustic: standard deviation of fundamental frequency

    AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.

  • Acoustic: jitter%

    AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.

  • Acoustic: shimmer%

    AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.

  • Acoustic: cepstral peak prominence

    AM (before teaching) and PM (after teaching) 5 days a week for up to 3 months.

  • +5 more secondary outcomes

Study Arms (3)

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.

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.

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.

Behavioral: Telepractice, Vocal Hygiene and Vocal Education

Interventions

Behavioral: Telepractice Global Voice Prevention Model
Behavioral: In-person Global Voice Prevention Model
Behavioral: Telepractice, Vocal Hygiene and Vocal Education

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elizabeth Grillo

West Chester, Pennsylvania, 19383, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations