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

• ClinicalTrials.gov Identifier: NCT01129141
• Recruitment Status: Completed
• First Posted: May 24, 2010
• Results First Posted: November 23, 2016
• Last Update Posted: January 26, 2017
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tinnitus	Procedure: Tele-PTM; Procedure: Wait List Control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Telehealth Tinnitus Intervention for Patients With TBI
• Study Start Date: January 2011
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Procedure: 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.
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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Tinnitus Functional Index [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Oregon

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States, 97239

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: James A. Henry, PhD; VA Portland Health Care System, Portland, OR

More Information

Publications of Results:

Henry JA, Griest S, Thielman E, McMillan G, Kaelin C, Carlson KF. Tinnitus Functional Index: Development, validation, outcomes research, and clinical application. Hear Res. 2016 Apr;334:58-64. doi: 10.1016/j.heares.2015.06.004. Epub 2015 Jun 12.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Henry JA, Thielman EJ, Zaugg TL, Kaelin C, McMillan GP, Schmidt CJ, Myers PJ, Carlson KF. Telephone-Based Progressive Tinnitus Management for Persons With and Without Traumatic Brain Injury: A Randomized Controlled Trial. Ear Hear. 2019 Mar/Apr;40(2):227-242. doi: 10.1097/AUD.0000000000000609.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01129141
• Other Study ID Numbers: C7452-I
• First Posted: May 24, 2010
• Results First Posted: November 23, 2016
• Last Update Posted: January 26, 2017
• Last Verified: November 2016

Keywords provided by VA Office of Research and Development:

Tinnitus; Traumatic Brain Injury Counseling; Counseling; Education; Evaluation studies; Quality of health care

Additional relevant MeSH terms:

Tinnitus; Nervous System Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations