Multi-Site Evaluation of Progressive Tinnitus Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01015781
First received: November 16, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

This multi-site study evaluated the implementation of Progressive Tinnitus Management (PTM), which combines both Audiology and Psychology approaches to Tinnitus Management. Those Veterans who require intervention for tinnitus have different levels of need, and this progressive approach gives them the appropriate level of intervention.


Condition Intervention
Tinnitus
Procedure: Progressive Tinnitus Management
Procedure: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Site Evaluation of Progressive Tinnitus Management

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Tinnitus Handicap Inventory [ Time Frame: Baseline, 6 months (from Baseline), 12 months (from Baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tinnitus & Hearing Survey [ Time Frame: Baseline, 6 months (from Baseline), 12 months (from Baseline) ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Progressive Tinnitus Management
Procedure: Progressive Tinnitus 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) Interdisciplinary Evaluation; 5) Individualized Support
Other Name: PTM
Arm 2
Usual Care
Procedure: Usual Care
VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.

Detailed Description:

Objectives. We completed a single-site pilot project to develop and evaluate Progressive Tinnitus Management (PTM). PTM takes into account the fact that most Veterans who complain of tinnitus do not require extensive intervention. The method thus is "progressive" in that a hierarchical approach is used to provide clinical services only to the degree needed by individual patients. Preliminary analyses of our pilot data provide evidence that PTM is an effective and efficient means of providing tinnitus management services to Veterans. Importantly, The Veterans Affairs (VA) Audiology and Speech Pathology Program Office has identified PTM as a standardized method of tinnitus management for use at all VA medical centers. It is essential to more definitively evaluate PTM for routine application at VA medical centers. Accordingly, the specific aim of this study was to conduct a randomized clinical trial at multiple VA medical centers to evaluate the effectiveness and clinical utility of PTM as compared to usual care.

Plan. The 3-year study was based at the VA National Center for Rehabilitative Auditory Research (NCRAR), and PTM was implemented and evaluated in a randomized clinical trial at the Memphis VA Medical Center and at the VA Connecticut Healthcare System (West Haven). During months 0-6: (a) All clinical materials for conducting PTM were modified (especially with the addition of Cognitive-Behavioral Therapy - CBT); (b) training materials were developed (the web-based PTM training program for VA audiologists was updated; PTM training will be developed for VA psychologists); (c) by random selection, five audiologists (two in Memphis, three in West Haven) were identified to conduct PTM and five (two in Memphis, three in West Haven) were identified to conduct usual care; (d) the five PTM audiologists (the West Haven study psychologist developed the training). By month 7, the randomized clinical trial was implemented at the two VA sites and continued through year 3.

Methods. Prior to conducting the clinical trial, PTM was modified to incorporate critical components of CBT at all levels of intervention so as to address the psychological effects of tinnitus. Qualifying Veteran subjects (n=150 at each site) were randomized into either PTM or usual care. Self-perceived tinnitus handicap was evaluated pre- and post-intervention for each subject using the Tinnitus Handicap Inventory. The five audiologists and two psychologists who participate in this study were interviewed to determine their level of satisfaction with the PTM protocol to which they are assigned. Evaluation of the program will determine its efficacy, and will identify areas of needed improvement.

Relevance to VA's Mission. Although tinnitus is the second most common service-connected disability, most VA medical centers do not provide comprehensive clinical services for Veterans suffering from tinnitus. This study extends our current work, which has focused on the development of a comprehensive tinnitus management protocol that can be implemented efficiently in VA hospitals. Further development of PTM has the potential of providing needed tinnitus services to Veterans across the country for a relatively small cost and with minimal impact on individual VA hospitals.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • are eligible for audiology services at their respective VAMC;
  • report the chronic presence of tinnitus (i.e., they have tinnitus that they can usually hear when they listen for it in a quiet room);
  • report that their tinnitus is at least a "small" problem; and
  • are willing to give verbal consent.

Exclusion Criteria:

  • are not Veterans;
  • have received previous tinnitus services at their VAMC;
  • report that their tinnitus is "no problem";
  • are unable (for any reason) to fulfill all of the requirements of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015781

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Tennessee
VA Medical Center, Memphis
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Investigators
Principal Investigator: James Henry, PhD VA Medical Center, Portland
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01015781     History of Changes
Other Study ID Numbers: C7213-R
Study First Received: November 16, 2009
Last Updated: May 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Tinnitus
Counseling
Education
Rehabilitation of hearing impaired
Triage
Evaluation studies
Quality of health care

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014