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Multi-Site Evaluation of Progressive Tinnitus Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01015781
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tinnitus
Interventions Procedure: Progressive Tinnitus Management
Procedure: Wait List Control
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immediate Care Wait List Control
Hide Arm/Group Description Immediate Care: 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) Interdisciplinary Evaluation; 5) Individualized Support Wait List Control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
Period Title: Overall Study
Started 150 150
Completed 113 121
Not Completed 37 29
Arm/Group Title Immediate Care Wait List Control Total
Hide Arm/Group Description 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) Interdisciplinary Evaluation; 5) Individualized Support VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate. Total of all reporting groups
Overall Number of Baseline Participants 150 150 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 150 participants 300 participants
57.72  (13.92) 58.05  (12.05) 57.89  (12.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
Female
5
   3.3%
9
   6.0%
14
   4.7%
Male
145
  96.7%
141
  94.0%
286
  95.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 150 participants 150 participants 300 participants
150 150 300
1.Primary Outcome
Title Tinnitus Functional Index Change Score
Hide Description

The Tinnitus Functional Index (TFI) is a tinnitus outcome measure that has been validated for "responsiveness" (Meikle et al., 2012). Prior to the TFI, no tinnitus questionnaire had been specifically designed and tested to maximize responsiveness to treatment-related change.

Completion of the 25-item TFI results in an index score that can range from 0 to 100, with higher scores reflecting greater problems associated with tinnitus. The following is a general guide to facilitate interpretation of TFI scores:

  • <25 = relatively mild tinnitus (little or no need for intervention)
  • 25-50 = significant problems with tinnitus (possible need for intervention) •>50 = tinnitus severe enough to qualify for more aggressive intervention Data from the TFI development study (Meikle et al., 2012) suggest that a reduction in the TFI score of at least 13 points would indicate a clinical improvement that a patient would consider important or meaningful.
Time Frame Baseline, 6 months (from Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was "intention to treat (ITT)". Includes all subjects from whom both baseline and 6 month data were collected.
Arm/Group Title Immediate Care Wait List Control
Hide Arm/Group Description:
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) Interdisciplinary Evaluation; 5) Individualized Support
VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
Overall Number of Participants Analyzed 112 119
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.71  (18.77) .8  (17.47)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and other [non-serious] adverse events were not collected or assessed as part of the study
 
Arm/Group Title Immediate Care Wait List Control
Hide Arm/Group Description Immediate Care: 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) Interdisciplinary Evaluation; 5) Individualized Support Wait List control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.
All-Cause Mortality
Immediate Care Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Immediate Care Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immediate Care Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James A. Henry, Ph.D., Principal Investigator
Organization: VA RR&D, NCRAR
Phone: 5032208262 ext 57466
EMail: james.henry@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01015781    
Other Study ID Numbers: C7213-R
First Submitted: November 16, 2009
First Posted: November 18, 2009
Results First Submitted: November 19, 2014
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014