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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01129141
First received: May 20, 2010
Last updated: December 21, 2015
Last verified: December 2015

May 20, 2010
December 21, 2015
January 2011
September 2015   (final data collection date for primary outcome measure)
Tinnitus Handicap Inventory [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01129141 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Telephone Tinnitus Education for Patients With Traumatic Brain Injury (TBI)
Telehealth Tinnitus Intervention for Patients With TBI
This study will continue the investigators' efforts to develop tinnitus management protocols for Veterans. More specifically, this study will develop and evaluate an adaptation of Progressive Tinnitus Management (PTM) for use as a telephone-based program for Veterans and military personnel who have experienced TBI. Adaptation of PTM as a telephone-based program 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.

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 are completing 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 Telephone Tinnitus Education (TTE). Preliminary data analyses indicate that TTE is effective. The present study will modify the TTE program in accordance with pilot study findings and evaluate the modified TTE using a randomized clinical trial design.

The 4-year study will be based at the VA National Center for Rehabilitative Auditory Research (NCRAR). TTE will be implemented and evaluated in a randomized clinical trial. Qualified candidates will be randomized to receive either immediate-TTE or Wait-List Control (WLC). All subjects will complete questionnaires at baseline and at 3, 6, 9, and 12 months post-baseline. The WLC group will receive TTE after completing the 6-month questionnaires. The primary outcome measure will be the Tinnitus Handicap Inventory (THI).

TTE intervention 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 is provided by the Study Psychologist at weeks 1, 3, and 5, and by the Study Audiologist at weeks 2 and 4, and months 3 and 6.

TTE 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tinnitus
  • Procedure: Telephone Tinnitus Education
    Telephone Tinnitus Education (TTE) is a novel home-based telehealth program. TTI intervention 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 is provided by the Study Psychologist at weeks 1, 3, and 5, and by the Study Audiologist at weeks 2 and 4, and months 3 and 6.
    Other Name: TTI
  • Procedure: Wait List Control
    Wait List Control subjects will receive TTE after completing the 6-month questionnaires. Participants assigned to Wait List Control will be instructed that they are allowed to receive any services for their tinnitus that are available to them, and that they will receive TTE following completion of the 3- and 6-month questionnaires.
  • Experimental: Arm 1
    Telephone Tinnitus Education (TTE)
    Intervention: Procedure: Telephone Tinnitus Education
  • Arm 2
    Wait List Control
    Intervention: Procedure: Wait List Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
September 2015
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01129141
C7452-I
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: James A. Henry, PhD VA Portland Health Care System, Portland, OR
VA Office of Research and Development
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP