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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  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.

Participant Flow:   Overall Study
    Tinnitus Progressive Management   Usual Care
STARTED   92   89 
COMPLETED   58   68 
NOT COMPLETED   34   21 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  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.
Total Total of all reporting groups

Baseline Measures
   Tinnitus Progressive Management   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 92   89   181 
Age 
[Units: Years]
Mean (Standard Deviation) 		 56.0  (11.2)   59.0  (10.5)   57.5  (10.8) 
Gender 
[Units: Participants]
 		     
Female   3   2   5 
Male   89   87   176 
Region of Enrollment 
[Units: Participants]
 		     
United States   92   89   181 


  Outcome Measures

1.  Primary:   THI (Tinnitus Handicap Inventory)   [ Time Frame: Baseline, 6 months ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: James A. Henry, Ph.D.
Organization: VA RR&D, NCRAR
phone: 5032208262 ext 57466
e-mail: james.henry@va.gov


Publications of Results:


Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00371436     History of Changes
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