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NCT03576365 · ClinicalTrials.gov registry record · NA
Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
A NA study of Voice Disorders and Dysphonia, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 2
- Study locations
NCT03576365: Completed NA study of Voice Disorders and Dysphonia, sponsored by University of Minnesota.
NCT03576365 is a NA study of Voice Disorders and Dysphonia that has completed, run by University of Minnesota. The registered enrollment target is 70 participants, below the 87-participant average among 7 other Voice Disorders trials with a reported enrollment target (20% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03576365, a NA study of Voice Disorders and Dysphonia, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to pilot test a version of the intervention that has been tailored for participants with dysphonia. The study seeks to determine if the adapted intervention: a) increases perceived control over voice-related stressors and b) decreases stress and distress resulting from voice problems. The study will also explore the usability and acceptability of the program. The goal is to help people with voice problems achieve better voice and quality of life outcomes.
Primary Outcome
Change from baseline assessment using a questionnaire, Perceived Present Control-8 (PPC-8). The PPC-8 questionnaire has 8 questions about perceptions of present control over their voice problem, assessed on a 4-point Likert-type scale, with scores of 1-4 (1=Strongly Disagree, 2=Disagree Somewhat, 3=Agree Somewhat, 4=Strongly Agree). Total scores range from 1-32. Higher scores indicate more perceived control over the patient's voice problems.
Conditions Studied
Interventions
- BEHAVIORAL VOICE Intervention Arm
- BEHAVIORAL Information-Only Arm
Study Locations (2)
Minnesota
- University of Minnesota Health Maple Grove Clinic - Maple Grove
- University of Minnesota Health Clinics and Surgeries Otolaryngology Clinic - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2016-04-11 |
| Est. Completion | 2025-01-14 |
| Phase | NA |
What the finished NCT03576365 record still lists
NCT03576365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 87-participant average among 7 other Voice Disorders trials with a reported enrollment target (20% lower).
The record links to 3 conditions, with Voice Disorders appearing as the primary indexed condition, and to 2 interventions - of which VOICE Intervention Arm is the first listed.
NCT03576365 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03576365 about?
NCT03576365 is a clinical study titled "Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention". The purpose of this study is to pilot test a version of the intervention that has been tailored for participants with dysphonia. The study seeks to determine if the adapted intervention: a) increases perceived control over voice-related stressors and b) decreases stress and distress resulting from v...
What is the current status of trial NCT03576365?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2016-04-11. Estimated completion is 2025-01-14.
What conditions does trial NCT03576365 study?
This clinical trial studies the following conditions: Voice Disorders, Dysphonia, Functional Dysphonia.
What interventions are being tested in trial NCT03576365?
The interventions under investigation include: VOICE Intervention Arm (BEHAVIORAL), Information-Only Arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT03576365?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03576365 being conducted?
This trial has 2 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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