Testing a Smart Phone App to Enhance Voice Therapy Adherence
1 other identifier
interventional
33
1 country
1
Brief Summary
The current project is designed as phase 1 study conducted to improve/enhance normal voice. Fifteen Thirty non-treatment seeking individuals, with no identifiable vocal pathology on laryngeal examination, will be randomized to one of two groups; 1) Voice therapy delivery without App (control/standard of care), 2) Voice therapy delivery with app (experimental). Participants in both groups will attend weekly voice therapy sessions (for 6 weeks) with the PI and Co- I (Joseph Stemple). Control group participants will be provided with an audio file of the exercises, and an exercise log sheet to track progress. Experimental group participants will use the smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track. Three-wave surveys will be conducted at the baseline, four weeks and 6 weeks after the intervention. Other data sources include study administration, exercise logs, app data, and clinical assessment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedFirst Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
June 28, 2019
CompletedJune 28, 2019
June 1, 2019
2 months
June 26, 2019
June 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence
Number of completed home practice sessions
6 weeks
Secondary Outcomes (1)
MPT (maximum phonation time)
6 weeks
Study Arms (2)
Traditional Voice Therapy
ACTIVE COMPARATORStandard of care (traditional) voice therapy.
App Group
EXPERIMENTALVoice therapy using a smartphone app.
Interventions
Traditional method of voice therapy
Smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track.
Eligibility Criteria
You may qualify if:
- Adults \> 18 years
- Non-smokers
- Hearing level within normal limits
- Absence of vocal fold pathology as confirmed by MD on laryngeal examination
- Agree to avoid vocally abusive behaviors for the entirety of the study
You may not qualify if:
- Apple phone (iOS)
- Impaired hearing
- Uncontrolled asthma
- Smoking
- H/o vocal fold surgery
- Presence of vocal fold pathology
- Previous history of experience with VFE performance
- Non-English speaking participants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vrushali Angadilead
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vrushali Angadi
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single-blinded to primary outcome measure
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 26, 2019
First Posted
June 28, 2019
Study Start
October 1, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
June 28, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share