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Improving Efficacy of Voice Therapy Concepts Via Telepractice and Mobile App Technology

Primary Purpose

Voice Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conversation Training Therapy
Global Voice Prevention and Therapy Model
Modified Conversation Training Therapy
Modified Global Voice Prevention and Therapy Model
Sponsored by
West Chester University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Voice Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Vocally healthy student in a bachelor of education program with student teaching planned for spring
  • Professional teacher who is currently working as a teacher with voice complaints, but has not sought help for the complaints
  • Owner of either an android or iOS smartphone or tablet.

Exclusion Criteria:

  • Not a student teacher
  • Not a professional teacher.
  • Does not own a smartphone.

Sites / Locations

  • Elizabeth GrilloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Conversation Training Therapy

Global Voice Prevention and Therapy Model

Modified Conversation Training Therapy

Modified Global Voice Prevention and Therapy Model

Arm Description

Outcomes

Primary Outcome Measures

Change in Voice Handicap Index 10
The VHI-10 is a client reported outcome measure related to voice impact on quality of life across 10 questions. Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.
Change in Vocal Fatigue Index (VFI) factor 1 and 2
The VFI is a client reported outcome measure related to tiredness and avoidance of voice in factor 1 and physical voice discomfort in factor 2. Factor 1 has 11 questions and factor 2 has 5 questions. Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.

Secondary Outcome Measures

Change in Fundamental Frequency
Fundamental frequency will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in Jitter%
Jitter% will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in noise-to-harmonic ratio
Noise-to-harmonic ratio will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in cepstral peak prominence
Cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in smoothed cepstral peak prominence
Smoothed cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Change in acoustic voice quality index
Acoustic voice quality index will be measured during 1 trial of the 5-sec sustained /a/ and the phrase, "we were away a year ago,"
Change in Borg Category Ratio (CR)10 scale for vocal effort
The Borg CR10 scale rates vocal effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.
Change in Borg Category Ratio (CR)10 scale for mental effort
The Borg CR10 scale rates mental effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.
Student researcher (SR) voice therapy satisfaction surveys
The voice therapy satisfaction survey will rate the student researchers' (SR) perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with 1 as strongly disagree and 5 as strongly agree. There are also some open ended responses. The SR survey has 17 questions.
Participant voice therapy satisfaction surveys
The voice therapy satisfaction surveys will rate the participants' perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with1 as strongly disagree and 5 as strongly agree. There are also some open ended responses. The participant survey has 12 questions.

Full Information

First Posted
January 6, 2022
Last Updated
May 18, 2023
Sponsor
West Chester University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05220982
Brief Title
Improving Efficacy of Voice Therapy Concepts Via Telepractice and Mobile App Technology
Official Title
Improving Efficacy of Voice Therapy Concepts Via Telepractice and Mobile App Technology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Chester University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Due to the COVID-19 pandemic, telepractice has grown rapidly. To date, synchronous telepractice (i.e., in real-time videoconferencing) has been the focus of most research with asynchronous telepractice (i.e. information stored and accessed later) being used minimally only to record synchronous encounters. Descriptions of voice therapy concepts are minimally available in the literature with no standard reporting framework and no clinical efficacy or effectiveness data. Thus, the proposed study will address these barriers. First, an asynchronous method will be developed that will impact both in-person and telepractice services by offering repeated learning opportunities in the client's environment. The method includes ecological momentary intervention (EMI) through a daily voice therapy practice app, server, and web portal that is flexible in its programming to meet the needs of the client, offers performance feedback, and charts results over time. Second, voice therapy concepts will be tested improving our knowledge about such concepts that facilitate successful client-centered outcomes for both prevention and treatment of voice problems. The participants in the study will be teachers who have a high prevalence of voice problems, impact the healthcare system when treatment is needed, and negatively affect students' learning abilities in the classroom when communicating with a voice problem. Third, the Rehabilitation Treatment Specification System (RTSS) framework will be used to describe the voice therapy concepts. The concepts include: training multiple voices to meet all the clients' vocal needs, defining voice qualities by the anatomy and physiology of the voice production system, generalizing voice targets into hierarchical speech tasks, and using "new" vs "other/old" voice to help the client become their own clinician. Vocally healthy student teachers and professional teachers with voice complaints will be randomized into one of four voice therapy conditions delivered via telepractice. Both groups of teachers are needed to assess the concepts for prevention and treatment. Condition 2, which fully represents the proposed voice therapy concepts, will be superior to the other three conditions, which do not fully represent the concepts, by demonstrating a greater decrease in client-reported primary outcome measures of the Voice Handicap Index-10 and factor 1 and 2 of the Vocal Fatigue Index. Secondary outcomes of acoustic measures, Borg Category Ratio-10 scales for vocal and mental effort, and voice therapy satisfaction surveys will also be investigated. The results will be useful at a practical level by advancing asynchronous telepractice and by improving efficacy of voice therapy concepts. In addition, the results will lay the groundwork for future studies involving development of EMI platforms in other areas of speech-language pathology and testing additional voice therapy concepts that facilitate successful client-centered outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conversation Training Therapy
Arm Type
Experimental
Arm Title
Global Voice Prevention and Therapy Model
Arm Type
Experimental
Arm Title
Modified Conversation Training Therapy
Arm Type
Experimental
Arm Title
Modified Global Voice Prevention and Therapy Model
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Conversation Training Therapy
Intervention Description
Training clear speech in conversation with new vs old voice. Training will occur over four weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.
Intervention Type
Behavioral
Intervention Name(s)
Global Voice Prevention and Therapy Model
Intervention Description
Training of four new voices (i.e., resonant voice in connected speech, falsetto for quiet talking, oral twang for talking over noise, and belt for healthy yelling) defined and trained by the anatomy and physiology of the system (i.e., Estill Voice Training's Figures). Training occurs in a bottom-up speech hierarchy with new vs other or old voice at each step. Additional methods are used in asynchronous telepractice to support the new voices during week 1 (e.g., vocal hygiene and education). Training will occur over three weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.
Intervention Type
Behavioral
Intervention Name(s)
Modified Conversation Training Therapy
Intervention Description
Training clear speech in conversation with no use of new vs old voice. Training will occur over four weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.
Intervention Type
Behavioral
Intervention Name(s)
Modified Global Voice Prevention and Therapy Model
Intervention Description
Training of a new resonant voice in connected speech defined and trained by the anatomy and physiology of the system (i.e., Estill Voice Training's Figures). Training occurs in a bottom-up speech hierarchy with no use of new vs old voice. Additional methods are used in asynchronous telepractice to support the new voices during week 1 (e.g., vocal hygiene and education). Training will occur over three weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.
Primary Outcome Measure Information:
Title
Change in Voice Handicap Index 10
Description
The VHI-10 is a client reported outcome measure related to voice impact on quality of life across 10 questions. Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 4 in the PM for a 5 day period via the VoiceEvalU8 app.
Title
Change in Vocal Fatigue Index (VFI) factor 1 and 2
Description
The VFI is a client reported outcome measure related to tiredness and avoidance of voice in factor 1 and physical voice discomfort in factor 2. Factor 1 has 11 questions and factor 2 has 5 questions. Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 5 in the PM for a 5 day period via the VoiceEvalU8 app.
Secondary Outcome Measure Information:
Title
Change in Fundamental Frequency
Description
Fundamental frequency will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
Title
Change in Jitter%
Description
Jitter% will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
Title
Change in noise-to-harmonic ratio
Description
Noise-to-harmonic ratio will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
Title
Change in cepstral peak prominence
Description
Cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
Title
Change in smoothed cepstral peak prominence
Description
Smoothed cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
Title
Change in acoustic voice quality index
Description
Acoustic voice quality index will be measured during 1 trial of the 5-sec sustained /a/ and the phrase, "we were away a year ago,"
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
Title
Change in Borg Category Ratio (CR)10 scale for vocal effort
Description
The Borg CR10 scale rates vocal effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.
Title
Change in Borg Category Ratio (CR)10 scale for mental effort
Description
The Borg CR10 scale rates mental effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.
Time Frame
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.
Title
Student researcher (SR) voice therapy satisfaction surveys
Description
The voice therapy satisfaction survey will rate the student researchers' (SR) perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with 1 as strongly disagree and 5 as strongly agree. There are also some open ended responses. The SR survey has 17 questions.
Time Frame
Collected immediately after intervention in the fall via Qualtrics online software.
Title
Participant voice therapy satisfaction surveys
Description
The voice therapy satisfaction surveys will rate the participants' perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with1 as strongly disagree and 5 as strongly agree. There are also some open ended responses. The participant survey has 12 questions.
Time Frame
Collected immediately after intervention in the fall via Qualtrics online software.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Vocally healthy student in a bachelor of education program with student teaching planned for spring Professional teacher who is currently working as a teacher with voice complaints, but has not sought help for the complaints Owner of either an android or iOS smartphone or tablet. Exclusion Criteria: Not a student teacher Not a professional teacher. Does not own a smartphone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth U Grillo, Ph.D.
Phone
6104362132
Email
egrillo@wcupa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth U Grillo, Ph.D.
Organizational Affiliation
West Chester University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elizabeth Grillo
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19383
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth U Grillo, Ph.D.
Phone
610-436-2132
Email
egrillo@wcupa.edu

12. IPD Sharing Statement

Learn more about this trial

Improving Efficacy of Voice Therapy Concepts Via Telepractice and Mobile App Technology

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