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

Dysphonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237648
• Other study ID #: 21-01409
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Efstratios Achlatis
• Phone: 646-754-1206
• Email: Efstratios.achlatis[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysphonia

Intervention

Other:
• Online Voice quality education module
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.
• Vocal hygiene module
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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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