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Progressive Intervention Program for Tinnitus Management

Primary Purpose

Hearing Loss, Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive Audiologic Tinnitus Management
Usual Care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Counseling, Education, Evaluation studies, Quality of health care, Rehabilitation of hearing impaired, Triage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James A. Haley Veterans Hospital, Tampa
  • VA Medical Center, Portland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Progressive Audiologic Tinnitus Management (PATM)

Usual Care (UC)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

THI (Tinnitus Handicap Inventory)
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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2006
Last Updated
March 24, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00371436
Brief Title
Progressive Intervention Program for Tinnitus Management
Official Title
Progressive Intervention Program for Tinnitus Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Tinnitus
Keywords
Counseling, Education, Evaluation studies, Quality of health care, Rehabilitation of hearing impaired, Triage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Audiologic Tinnitus Management (PATM)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care (UC)
Arm Type
Other
Arm Description
Typical audiologic care that would be received in a VA Audiology Clinic.
Intervention Type
Procedure
Intervention Name(s)
Progressive Audiologic Tinnitus Management
Other Intervention Name(s)
PATM
Intervention Description
The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.
Intervention Type
Procedure
Intervention Name(s)
Usual Care
Other Intervention Name(s)
UC
Intervention Description
Typical audiologic care that would be received in a VA Audiology Clinic.
Primary Outcome Measure Information:
Title
THI (Tinnitus Handicap Inventory)
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Henry, PhD
Organizational Affiliation
VA Medical Center, Portland
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Haley Veterans Hospital, Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
VA Medical Center, Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20625568
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.
Results Reference
result
PubMed Identifier
25144174
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.
Results Reference
result
Links:
URL
http://www.ncrar.research.va.gov/Research/active7.asp
Description
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