Clinical trial NCT05237648: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dysphonia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of voice handicap perception across the 3 groups
timeFrame: Baseline (Day 1) visit, 8 - 10 week visit
measure: Change of Online education module acceptance across the 3 groups
timeFrame: Baseline Visit (Day 1), Last day of visit (up to 4 months from baseline)
Secondary outcomes:
measure: Change of perceived effectiveness of voice therapy
timeFrame: Baseline (Day 1) visit, 8 - 10 week visit
measure: Change of patient's perception on voice therapy
timeFrame: Baseline (Day 1) visit, 8 - 10 week visit
measure: Change of perceptual voice ratings
timeFrame: Baseline (Day 1) visit, 8 - 10 week visit
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Aaron Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: