Clinical trial NCT00371436: Progressive Intervention Program for Tinnitus Management
Official title: Progressive Intervention Program for Tinnitus Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Tinnitus
Keywords: Counseling
Education
Evaluation studies
Quality of health care
Rehabilitation of hearing impaired
Triage
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-09-04
Enrollment: 181
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: THI (Tinnitus Handicap Inventory)
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans Hospital, Tampa
state: Florida
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
Study officials:
affiliation: VA Medical Center, Portland
name: James A Henry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henry JA, Zaugg TL, Myers PJ, Kendall CJ, Michaelides EM. A triage guide for tinnitus. J Fam Pract. 2010 Jul;59(7):389-93. No abstract available.
citation: Myers PJ, Griest S, Kaelin C, Legro MW, Schmidt CJ, Zaugg TL, Henry JA. Development of a progressive audiologic tinnitus management program for Veterans with tinnitus. J Rehabil Res Dev. 2014;51(4):609-22. doi: 10.1682/JRRD.2013.08.0189.