Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00371436 |
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.
Condition | Intervention |
---|---|
Hearing Loss Tinnitus |
Procedure: Tinnitus Progressive Management Procedure: Usual Care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Progressive Intervention Program for Tinnitus Management |
Estimated Enrollment: | 180 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Tinnitus Progressive Management
|
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.
|
2
Usual Care
|
Procedure: Usual Care
Typical audiologic care that would be received in a VA Audiology Clinic.
|
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Veterans who:
Exclusion Criteria:
Contact: Christine S Kaelin, MBA | (503) 220-8262 ext 57153 | christine.kaelin@va.gov |
Contact: Tara Zaugg | (503) 220-8262 ext 56608 | Tara.Zaugg@va.gov |
United States, Florida | |
James A. Haley Veterans Hospital, Tampa | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Katie Ketter, BA katie.ketter@va.gov | |
United States, Oregon | |
VA Medical Center, Portland | Active, not recruiting |
Portland, Oregon, United States, 97201 |
Principal Investigator: | James Henry, PhD | VA Medical Center, Portland |
Responsible Party: | Department of Veterans Affairs ( Henry, James - Principal Investigator ) |
Study ID Numbers: | C4488R |
Study First Received: | August 31, 2006 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00371436 History of Changes |
Health Authority: | United States: Federal Government |
Counseling Education Evaluation studies |
Quality of health care Rehabilitation of hearing impaired Triage |
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness Otorhinolaryngologic Diseases |
Neurologic Manifestations Hearing Loss Ear Diseases Tinnitus |
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness Otorhinolaryngologic Diseases |
Nervous System Diseases Neurologic Manifestations Hearing Loss Ear Diseases Tinnitus |