Trial Outcomes & Findings for Multi-Site Evaluation of Progressive Tinnitus Management (NCT NCT01015781)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

Baseline, 6 months (from Baseline)

Results posted on

2014-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate Care Immediate Care: 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	Wait List Control Wait List Control: 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. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
Overall Study STARTED	150	150
Overall Study COMPLETED	113	121
Overall Study NOT COMPLETED	37	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Site Evaluation of Progressive Tinnitus Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Care n=150 Participants 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	Wait List Control n=150 Participants 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. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.	Total n=300 Participants Total of all reporting groups
Age, Continuous	57.72 years STANDARD_DEVIATION 13.92 • n=5 Participants	58.05 years STANDARD_DEVIATION 12.05 • n=7 Participants	57.89 years STANDARD_DEVIATION 12.99 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	145 Participants n=5 Participants	141 Participants n=7 Participants	286 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants	150 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months (from Baseline)

Population: The analysis was "intention to treat (ITT)". Includes all subjects from whom both baseline and 6 month data were collected.

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.

Outcome measures

Outcome measures
Measure	Immediate Care n=112 Participants 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	Wait List Control n=119 Participants 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. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
Tinnitus Functional Index Change Score	-5.71 units on a scale Standard Deviation 18.77	.8 units on a scale Standard Deviation 17.47

Adverse Events

Immediate Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James A. Henry, Ph.D., Principal Investigator

VA RR&D, NCRAR

Phone: 5032208262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place