Comparing Telepractice and Conventional Face-to-face Voice Therapy

NCT02922309 | Completed

• 1 other identifier: FEMH-IRB-104193-E
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. However, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus reduces treatment effects. The purpose of the study is to design a telecommunication vocal training system and a vocal training program for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study, including a single-blind, randomized controlled trial, to test the hypothesis that vocal training via telepractice for voice disordered elderly are not inferior to the standard face to face training.

Conditions

Dysphonia; Aged; Speech Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of 10-item voice handicap index at 2 months

  min: 0(best); Max: 40(worst);

  before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

Other Outcomes (7)

• Perceptual Analysis using grade, roughness, breathiness, asthenia, and strain

  before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

• Jitter

  before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

• Shimmer

  before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

Study Arms (2)

experimental

EXPERIMENTAL

Vocal Training via Telepractice

Behavioral: Vocal Training Via Telepractice

control

ACTIVE COMPARATOR

Vocal Training via face-to-face practice

Behavioral: Vocal Training Via face-to face practice

Interventions

Vocal Training Via Telepractice BEHAVIORAL

Vocal Training Via Telepractice, delivered by integrated communication service

experimental

Vocal Training Via face-to face practice BEHAVIORAL

Vocal Training Via face-to face practice at medical facilities

control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient equal or older than 55 years old
• Voice Handicap Index-10 (VHI-10) score \>10 point
• accessibility to a network connection

You may not qualify if:

• neurologic disorders
• active pulomanory disease
• mental disorder

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Related Publications (1)

• Lin FC, Chien HY, Chen SH, Kao YC, Cheng PW, Wang CT. Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-Face Therapy. J Speech Lang Hear Res. 2020 Jul 20;63(7):2132-2140. doi: 10.1044/2020_JSLHR-19-00364. Epub 2020 Jun 24.

  PMID: 32579859 DERIVED

MeSH Terms

Conditions

Dysphonia; Communication Disorders

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Chi-Te Wang, MD, PhD

  Department of Otolaryngology, Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 4, 2016
• Study Start: October 17, 2016
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share