Progressive Intervention Program for Tinnitus Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00371436
First received: August 31, 2006
Last updated: September 19, 2014
Last verified: September 2014

August 31, 2006
September 19, 2014
September 2008
September 2009   (final data collection date for primary outcome measure)
THI (Tinnitus Handicap Inventory) [ Time Frame: Baseline, end of Treatment, 6 months post-treatment ] [ Designated as safety issue: No ]
Baseline questionnaire at 12 and 24 months for general tinnitus survey, the Tinnitus Handicap Inventory (THI.)
Complete list of historical versions of study NCT00371436 on ClinicalTrials.gov Archive Site
SFV-36 [ Time Frame: Baseline, 6 months post-treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Progressive Intervention Program for Tinnitus Management
Progressive Intervention Program for Tinnitus Management

The purpose of this multi-site randomized clinical study is to test a model treatment program in a VA Audiology clinic, to evaluate its efficacy, ease of implementation, and acceptability to audiologists.

The 2004 VA Annual Benefits Report reveals that tinnitus is the third most common individual service-connected disability in veterans. As of September 30, 2005, there were 339,573 veterans who had been awarded a service connection for their tinnitus, with annual compensation amounting to over $418,000,000 (Office of Policy and Planning, VA Central Office). In addition to being a major expense for VHA, tinnitus is a health care problem that is inadequately addressed at most VA medical centers. We have developed a research-based model of tinnitus clinical management that is designed for efficient implementation in VA Audiology clinics. The objective of this study is to establish the model program at a VA Audiology clinic, and to evaluate its efficacy with veteran patients and its acceptability to audiologists.

The study is based at the NCRAR, and a prototype tinnitus management program will be established in the Audiology Clinic at the James A. Haley (Tampa) VA Medical Center. 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. It is hypothesized that progressive intervention will result in a significant reduction in self-perceived tinnitus handicap relative to usual care.

A comprehensive web-based tinnitus training course for audiologists has been developed, as well as a patient tinnitus-information book that uses principles of low health literacy. Six audiologists at the Tampa VA are participating in the study, of which three were randomly selected to complete the training course as preparation to conduct each of five levels of progressive intervention: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individualized management. The other three audiologists have not received the training, and these "usual care" audiologists provide intervention that more closely typifies what is done at some VA medical centers.

Patients will be randomized to one of the two groups. All patients will complete outcomes questionnaires (Tinnitus Handicap Inventory [THI] and Veterans Short Form-36 health survey [SF-36V]) at baseline, immediately post-treatment and 6 months post treatment. Outcomes of the THI will be compared between the two groups of patients to test the hypothesis. Data from the SF-36V will be used in secondary outcomes analyses. Each of the six audiologists will be interviewed informally to determine their satisfaction with the tinnitus services that they provide, and how they feel they are meeting the needs of their patients. The three web-based-trained audiologists will provide formative data to the Co-PI on an ongoing basis to monitor and adjust the program to achieve the best possible outcomes.

Development and evaluation of this prototype program will establish its practical utility for addressing the tinnitus needs of veterans in a comprehensive, yet efficient, fashion. If the study shows that the program is effective, then the program could establish the standard for tinnitus management at all VA medical centers-meeting the needs of all veterans who have access to VA services.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hearing Loss
  • Tinnitus
  • Procedure: 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.
  • Procedure: Usual Care
    Typical audiologic care that would be received in a VA Audiology Clinic.
  • Active Comparator: Arm 1
    Tinnitus Progressive Management
    Intervention: Procedure: Tinnitus Progressive Management
  • Arm 2
    Usual Care
    Intervention: Procedure: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Veterans who:

  • Are outpatients at VA clinics in the vicinity of the James A. Haley VA Medical Center in Tampa, FL
  • Have clinically significant tinnitus
  • Have no significant language barrier
  • Are capable of and willing to fulfill all study requirements

Exclusion Criteria:

  • Subjects must be free from any medical conditions that would interfere with study participation, e.g. medically or surgically treatable otologic disease; end-stage renal, pulmonary, or cardiovascular disease
  • Patients undergoing chemotherapy or radiation treatment
  • Patients with severe psychiatric disorders
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00371436
C4488-R
Not Provided
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: James A Henry, PhD VA Medical Center, Portland
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP