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Trial record 14 of 418 for:    "Communication Disorders"

Effectiveness of Delivering Vocal Training Via Telepractice for Elderly Using Integrated Communication Technology

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ClinicalTrials.gov Identifier: NCT02922309
Recruitment Status : Enrolling by invitation
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Chi-Te Wang, Far Eastern Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Dysphonia Aged Speech Therapy Behavioral: Vocal Training Via Telepractice Behavioral: Vocal Training Via face-to face practice Not Applicable

Detailed Description:

Randomization: per mutated block, 40 patients on each arms (experimental and control)

Allocation: sealed envelope indicating either of the 2 groups

Intervention: weekly vocal training, each course last for 30-40 minutes,lasting for 2 months

Outcome measurement: before treatment, 1 month, 3 months, and 6 months after treatment

Primary outcome: 10-item voice handicap index

Secondary outcome: acoustics and aerodynamic parameter


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: experimental
Vocal Training via Telepractice
Behavioral: Vocal Training Via Telepractice
Vocal Training Via Telepractice, delivered by integrated communication service
Active Comparator: control
Vocal Training via face-to-face practice
Behavioral: Vocal Training Via face-to face practice
Vocal Training Via face-to face practice at medical facilities



Primary Outcome Measures :
  1. Change from Baseline VHI-10 at 3 months [ Time Frame: Baseline and 3 months ]
    VHI-10: 10-item voice handicap index


Secondary Outcome Measures :
  1. Change from Baseline MPT at 3 months [ Time Frame: Baseline and 3 months ]
    MPT: maximal phonation time

  2. Change from Baseline perceptual voice quality at 3 months [ Time Frame: Baseline and 3 months ]
    Perceptual voice quality of participants rated by blinded raters



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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • patient equal or older than 55 years old
  • familiar with using mobile device and apps
  • no previous vocal training(voice therapy)

Exclusion criteria

  • neurologic disorders
  • active pulomanory disease
  • mental disorder
  • receiving major operation within 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922309


Sponsors and Collaborators
Chi-Te Wang
Investigators
Principal Investigator: Chi-Te Wang Department of Otolaryngology, Far Eastern Memorial Hospital

Responsible Party: Chi-Te Wang, MD, PhD, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02922309     History of Changes
Other Study ID Numbers: FEMH-IRB-104193-E
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Communication Disorders
Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurobehavioral Manifestations
Neurodevelopmental Disorders
Mental Disorders