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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
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
Conditions Hearing Loss
Tinnitus
Interventions Procedure: Progressive Audiologic Tinnitus Management
Procedure: Usual Care
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tinnitus Progressive Management Usual Care
Hide Arm/Group Description 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
Arm/Group Title Tinnitus Progressive Management Usual Care Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 92 participants 89 participants 181 participants
Female
3
   3.3%
2
   2.2%
5
   2.8%
Male
89
  96.7%
87
  97.8%
176
  97.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 92 participants 89 participants 181 participants
92 89 181
1.Primary Outcome
Title THI (Tinnitus Handicap Inventory)
Hide Description The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap.
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The THI was completed by 58 of the 92 PATM patients at both baseline and 6 months. The THI was completed by 68 of the 89 Usual Care patients at both baseline and 6 months.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

Tinnitus Progressive Management

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

Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.

Overall Number of Participants Analyzed 58 68
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 37.0  (24.3) 43.0  (25.4)
6 months 33.0  (26.4) 40.0  (27.6)
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 Tinnitus Progressive Management Usual Care
Hide Arm/Group Description 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.
All-Cause Mortality
Tinnitus Progressive Management Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tinnitus Progressive Management Usual Care
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%
Tinnitus Progressive Management Usual Care
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.
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: 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