Telephone Tinnitus Education for Patients With Traumatic Brain Injury (TBI)

Not Applicable

Completed

Conditions: Tinnitus

Interventions: Procedure: Wait List Control
Procedure: Tele-PTM

Registration Number: NCT01129141

Lead Sponsor: VA Office of Research and Development

Brief Summary: This study continues the investigators' efforts to develop tinnitus management protocols for Veterans. More specifically, this study developed and evaluated an adaptation of Progressive Tinnitus Management (PTM) for use as a telephone-based program for Veterans and military personnel who have experienced TBI. This adaptation, called Tele-PTM, is a telephone-based program and has the potential of providing needed tinnitus services to Veterans with and without TBI for a relatively small cost and with minimal impact on individual VA hospitals.

Detailed Description: Traumatic brain injury (TBI) is strongly associated with tinnitus. Tinnitus management for Veterans and military members with TBI has become a critical concern. The investigators' research has focused on developing effective, evidence-based methods of tinnitus management for Veterans. These efforts led to the development of Progressive Tinnitus Management (PTM). The investigators completed a pilot study to adapt PTM to meet the unique tinnitus management needs of Veterans and military members with TBI using a novel home-based telehealth program called Tele-PTM. Preliminary data analyses indicated that Tele-PTM is effective. The present study modified the PTM program in accordance with pilot study findings and evaluated Tele-PTM using a randomized clinical trial design.

The 4-year study was based at the VA National Center for Rehabilitative Auditory Research (NCRAR). Tele-PTM was implemented and evaluated in a randomized clinical trial. Qualified candidates were randomized to receive either Tele-PTM or Wait-List Control (WLC). All subjects completed questionnaires at baseline and at 3, 6, 9, and 12 months post-baseline. The WLC group received Tele-PTM after completing the 6-month questionnaires. The primary outcome measure was the Tinnitus Functional Index (TFI).

Tele-PTM involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.

Tele-PTM has the potential of providing needed tinnitus services to Veterans and active military personnel across the country for a relatively small cost and with minimal impact on individual VA hospitals.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 205

Inclusion Criteria

Inclusion criteria include:

"clinically significant" tinnitus according to the initial score on the Tinnitus and Hearing Survey (THS) (minimum total score of 4 on section A; if score is 4-6, one item must be at least 3);
demonstrates understanding of the requirements of the study (based on adequate responses to the questions by the RC that assess capacity-to-consent);
has had a hearing test within the past 2 years (and was fitted with hearing aids if appropriate); and
motivated and capable of participating (including ability to communicate over the telephone in English).

Exclusion Criteria

Callers who do not meet all of these criteria will be excluded from study participation.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait List Control	Wait List Control	Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
Tele-PTM	Tele-PTM	Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.

Primary Outcome Measures

Name	Time	Method
Tinnitus Functional Index	Baseline, 6 months	The TFI served as the primary outcome measure. The TFI is a 25-item self-report questionnaire that has documented validity both for scaling the severity and negative impact of tinnitus, and for measuring treatment-related changes in tinnitus (responsiveness) (Meikle et al., 2012). The total score for the TFI ranges from 0 to 100, with higher scores indicating greater problems with tinnitus. The TFI has excellent internal consistency (Cronbach's α = .97) and high test-retest reliability (r = .86) (Meikle et al., 2012). The authors of the TFI estimated that a 13-point decrease on the TFI for an individual is likely to reflect a change that feels meaningful to the person.

Secondary Outcome Measures