Progressive Intervention Program for Tinnitus Management
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ClinicalTrials.gov Identifier: NCT00371436 |
Recruitment Status :
Completed
First Posted : September 4, 2006
Results First Posted : April 8, 2015
Last Update Posted : April 8, 2015
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Sponsor:
US Department of Veterans Affairs
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Hearing Loss Tinnitus |
Interventions |
Procedure: Progressive Audiologic Tinnitus Management Procedure: Usual Care |
Enrollment | 181 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Tinnitus Progressive Management | Usual Care |
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Tinnitus Progressive Management: The program follows a five-level "progressive intervention" model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management. | Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic. |
Period Title: Overall Study | ||
Started | 92 | 89 |
Completed | 58 | 68 |
Not Completed | 34 | 21 |
Baseline Characteristics
Arm/Group Title | Tinnitus Progressive Management | Usual Care | Total | |
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Tinnitus Progressive Management: The program follows a five-level "progressive intervention" model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management. | Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic. | Total of all reporting groups | |
Overall Number of Baseline Participants | 92 | 89 | 181 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 92 participants | 89 participants | 181 participants | |
56.0 (11.2) | 59.0 (10.5) | 57.5 (10.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 92 participants | 89 participants | 181 participants | |
Female |
3 3.3%
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2 2.2%
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5 2.8%
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Male |
89 96.7%
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87 97.8%
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176 97.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 92 participants | 89 participants | 181 participants |
92 | 89 | 181 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | James A. Henry, Ph.D. |
Organization: | VA RR&D, NCRAR |
Phone: | 5032208262 ext 57466 |
EMail: | james.henry@va.gov |
Publications of Results:
Responsible Party: | VA Office of Research and Development ( US Department of Veterans Affairs ) |
ClinicalTrials.gov Identifier: | NCT00371436 |
Other Study ID Numbers: |
C4488-R |
First Submitted: | August 31, 2006 |
First Posted: | September 4, 2006 |
Results First Submitted: | November 13, 2014 |
Results First Posted: | April 8, 2015 |
Last Update Posted: | April 8, 2015 |