Multi-Site Evaluation of Progressive Tinnitus Management

NCT01015781 | Completed Results

• 1 other identifier: C7213-R
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Tinnitus

Keywords

Tinnitus; Counseling; Education; Rehabilitation of hearing impaired; Triage; Evaluation studies; Quality of health care

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index Change Score

  The Tinnitus Functional Index (TFI) is a tinnitus outcome measure that has been validated for "responsiveness" (Meikle et al., 2012). Prior to the TFI, no tinnitus questionnaire had been specifically designed and tested to maximize responsiveness to treatment-related change. Completion of the 25-item TFI results in an index score that can range from 0 to 100, with higher scores reflecting greater problems associated with tinnitus. The following is a general guide to facilitate interpretation of TFI scores: * \<25 = relatively mild tinnitus (little or no need for intervention) * 25-50 = significant problems with tinnitus (possible need for intervention) •\>50 = tinnitus severe enough to qualify for more aggressive intervention Data from the TFI development study (Meikle et al., 2012) suggest that a reduction in the TFI score of at least 13 points would indicate a clinical improvement that a patient would consider important or meaningful.

  Baseline, 6 months (from Baseline)

Study Arms (2)

Arm 1

EXPERIMENTAL

Progressive Tinnitus Management

Procedure: Progressive Tinnitus Management

Arm 2

OTHER

Wait List Control

Procedure: Wait List Control

Interventions

Progressive Tinnitus Management PROCEDURE

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

Also known as: PTM

Arm 1

Wait List Control PROCEDURE

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.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (3)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97201, United States

Location

VA Medical Center, Memphis

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: James A. Henry, Ph.D., Principal Investigator
• Organization: VA RR&D, NCRAR

james.henry@va.gov

5032208262

Study Officials

• James A Henry, PhD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 18, 2009
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

US (3)