search
Back to results

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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-PTM
Wait List Control
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Traumatic Brain Injury Counseling, Counseling, Education, Evaluation studies, Quality of health care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tele-PTM

Wait List Control

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Tinnitus Functional Index
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

Full Information

First Posted
May 20, 2010
Last Updated
November 30, 2016
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT01129141
Brief Title
Telephone Tinnitus Education for Patients With Traumatic Brain Injury (TBI)
Official Title
Telehealth Tinnitus Intervention for Patients With TBI
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Traumatic Brain Injury Counseling, Counseling, Education, Evaluation studies, Quality of health care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-PTM
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tele-PTM
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Wait List Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinnitus Functional Index
Description
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.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A. Henry, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26074306
Citation
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.
Results Reference
result
PubMed Identifier
29847413
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs