Back to resultsAssessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes
Primary Purpose
Dysphonia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Voice quality education module
Vocal hygiene module
Sponsored by
About this trial
This is an interventional treatment trial for Dysphonia
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- English-speaking
- Have access to technology, including Internet
- Diagnosed with dysphonia with a recommended treatment of voice therapy.
- Willingness to complete all clinical/research assessments
- Ability to give informed consent
Exclusion Criteria:
- Patients who undergo surgical intervention during the course of therapy Contraindications for participation in voice therapy
- Diagnosis of Parkinson's Disease or other neurodegenerative, progressive disorder (e.g., ALS)
- Previous training in acoustic-perceptual voice quality rating, for example a speech language pathology student
- Visual impairments that would prevent the completion of an online module.
- Those with self-reported moderate-profound hearing loss or deafness that would preclude them from participating in the study
- Inability to give informed consent
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Experimental Group
Sham Control Group
Control group
Arm Description
Participants will complete an online module with content focusing on patient self-rating of vocal quality within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session;
Participants will complete an online module within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session with content focusing on vocal hygiene.
Participants will not complete an online module. The groups will be compared in terms of attendance, self-efficacy, and treatment outcome measures based on the data collected within the NYU Voice Center standard of care
Outcomes
Primary Outcome Measures
Change of voice handicap perception across the 3 groups
Will be measured by Voice Handicap Index -10 (VHI-10), a patient reported outcome measure used to record the patient's perception of impairment or handicap due to a voice problem. A score of over 10 is considered to be abnormal. The scores in all three groups will be compared and analyzed.
Change of Online education module acceptance across the 3 groups
Will be measured by attendance data (number of sessions recommended versus attended, number of no shows) using the standard patient data collected according to standard of care process.
Secondary Outcome Measures
Change of perceived effectiveness of voice therapy
Self-Efficacy Scale for Voice Therapy will assess a patient's self-perception of their ability to achieve a goal. The Self-Efficacy Scale for Voice Therapy prompts patients to be "brutally honest" and rate their perceived capability to accomplish practice or generalization of skills in various daily and therapeutic situations and activities. Patients are asked to rate their certainty in these capabilities from 0 to 10, where 0 is not at all certain and 10 is extremely certain.
Change of patient's perception on voice therapy
Comparison of scores on the Patient Perception of Voice Therapy Questionnaire for therapy completers across the three groups as well as between those subjects who completed an online module (experimental and sham control groups) and those who did not (control group alone).
Change of perceptual voice ratings
CAPE-V will be used to measure experimental group patients and clinician perceptual voice rating. The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) indicates salient perceptual vocal attributes, identified by the core consensus group as commonly used and easily understood. The attributes are: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. The CAPE-V displays each attribute accompanied by a 100- millimeter line forming a visual analog scale (VAS). The clinician indicates the degree of perceived deviance from normal for each parameter on this scale, using a tic mark.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05237648
Brief Title
Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes
Official Title
Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
The purpose of this study is to assess the effects of incorporating educational online modules into voice therapy. One of the main reasons that voice therapy fails is lack of participation and engagement from the patient's side. The researchers hope to learn if increasing patient engagement via educational online modules during this waiting period between evaluation and first therapy session is useful in increasing understanding of the therapeutic framework of voice therapy.
Detailed Description
Attendance and adherence are established as consistent challenges in voice therapy. Specific logistical and psychological factors linked to these challenges include the interval between evaluation and initiation of treatment and components of patient motivation. The authors propose a novel online education module involving patient self-ratings of voice quality to be completed at various time points throughout the therapeutic process, including during the waiting period between initial evaluation and first treatment session. The authors hypothesize that completion of this module will increase patient understanding of the conceptual framework of therapy, provide opportunities for inclusion of patient-driven acoustic goals and establish skills in auditory and kinesthetic awareness, which are foundational to behavioral voice therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants will complete an online module with content focusing on patient self-rating of vocal quality within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session;
Arm Title
Sham Control Group
Arm Type
Sham Comparator
Arm Description
Participants will complete an online module within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session with content focusing on vocal hygiene.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will not complete an online module. The groups will be compared in terms of attendance, self-efficacy, and treatment outcome measures based on the data collected within the NYU Voice Center standard of care
Intervention Type
Other
Intervention Name(s)
Online Voice quality education module
Intervention Description
The novel online module the authors developed consists of a patient education on acoustic-perceptual rating of voice quality (CAPE-V), practice rating sample recordings of others' voices, and the patient's self-rating of their own voice in real time during a standard sentence-reading task. The module also includes the Self-Efficacy Scale for Voice Therapy.
Intervention Type
Other
Intervention Name(s)
Vocal hygiene module
Intervention Description
The generic online patient education module on vocal hygiene during the waiting period between their initial evaluation and their first therapy session that also includes the Self-Efficacy Scale for Voice Therapy
Primary Outcome Measure Information:
Title
Change of voice handicap perception across the 3 groups
Description
Will be measured by Voice Handicap Index -10 (VHI-10), a patient reported outcome measure used to record the patient's perception of impairment or handicap due to a voice problem. A score of over 10 is considered to be abnormal. The scores in all three groups will be compared and analyzed.
Time Frame
Baseline (Day 1) visit, 8 - 10 week visit
Title
Change of Online education module acceptance across the 3 groups
Description
Will be measured by attendance data (number of sessions recommended versus attended, number of no shows) using the standard patient data collected according to standard of care process.
Time Frame
Baseline Visit (Day 1), Last day of visit (up to 4 months from baseline)
Secondary Outcome Measure Information:
Title
Change of perceived effectiveness of voice therapy
Description
Self-Efficacy Scale for Voice Therapy will assess a patient's self-perception of their ability to achieve a goal. The Self-Efficacy Scale for Voice Therapy prompts patients to be "brutally honest" and rate their perceived capability to accomplish practice or generalization of skills in various daily and therapeutic situations and activities. Patients are asked to rate their certainty in these capabilities from 0 to 10, where 0 is not at all certain and 10 is extremely certain.
Time Frame
Baseline (Day 1) visit, 8 - 10 week visit
Title
Change of patient's perception on voice therapy
Description
Comparison of scores on the Patient Perception of Voice Therapy Questionnaire for therapy completers across the three groups as well as between those subjects who completed an online module (experimental and sham control groups) and those who did not (control group alone).
Time Frame
Baseline (Day 1) visit, 8 - 10 week visit
Title
Change of perceptual voice ratings
Description
CAPE-V will be used to measure experimental group patients and clinician perceptual voice rating. The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) indicates salient perceptual vocal attributes, identified by the core consensus group as commonly used and easily understood. The attributes are: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. The CAPE-V displays each attribute accompanied by a 100- millimeter line forming a visual analog scale (VAS). The clinician indicates the degree of perceived deviance from normal for each parameter on this scale, using a tic mark.
Time Frame
Baseline (Day 1) visit, 8 - 10 week visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
English-speaking
Have access to technology, including Internet
Diagnosed with dysphonia with a recommended treatment of voice therapy.
Willingness to complete all clinical/research assessments
Ability to give informed consent
Exclusion Criteria:
Patients who undergo surgical intervention during the course of therapy Contraindications for participation in voice therapy
Diagnosis of Parkinson's Disease or other neurodegenerative, progressive disorder (e.g., ALS)
Previous training in acoustic-perceptual voice quality rating, for example a speech language pathology student
Visual impairments that would prevent the completion of an online module.
Those with self-reported moderate-profound hearing loss or deafness that would preclude them from participating in the study
Inability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Efstratios Achlatis
Phone
646-754-1206
Email
Efstratios.achlatis@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Johnson, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efstratios Achlatis
Phone
646-754-1206
Email
Efstratios.achlatis@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Aaron Johnson, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Aaron.Johnson@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes
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