Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes

Conditions
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Dysphonia

Intervention / Treatment
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* Other: Online Voice quality education module
* Other: Vocal hygiene module


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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; | Other: Online Voice quality education module<br>* 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.<br>|
| Sham Comparator: Sham Control Group<br>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. | Other: Vocal hygiene module<br>* 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<br>|
| No Intervention: Control group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 1) visit, 8 - 10 week visit | 
| 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. | Baseline Visit (Day 1), Last day of visit (up to 4 months from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 1) visit, 8 - 10 week visit | 
| 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). | Baseline (Day 1) visit, 8 - 10 week visit | 
| 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. | Baseline (Day 1) visit, 8 - 10 week visit |