Telephone Tinnitus Education for Patients With Traumatic Brain Injury (TBI)
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Purpose
This study will continue our 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.
| Condition | Intervention |
|---|---|
|
Tinnitus |
Procedure: Telephone Tinnitus Education Procedure: Wait List Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Telehealth Tinnitus Intervention for Patients With TBI |
- Tinnitus Handicap Inventory [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 336 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Telephone Tinnitus Education (TTE)
|
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
|
|
Arm 2
Wait List Control
|
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.
|
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. Our 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). We 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria include:
- "clinically significant" tinnitus according to the initial score on the 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| Contact: Christine S Kaelin, MBA | (503) 220-8262 ext 57153 | christine.kaelin@va.gov |
| Contact: Emily Thielman, MS | (503) 220-8262 ext 51936 | emily.thielman@va.gov |
| United States, Oregon | |
| VA Medical Center, Portland | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: James Henry, PhD 503-220-8262 ext 57466 James.Henry@va.gov | |
| Contact: Christine S Kaelin, MBA (503) 220-8262 ext 57153 christine.kaelin@va.gov | |
| Principal Investigator: James Henry, PhD | |
| Principal Investigator: | James Henry, PhD | VA Medical Center, Portland |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01129141 History of Changes |
| Other Study ID Numbers: | C7452-I |
| Study First Received: | May 20, 2010 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Tinnitus Traumatic Brain Injury Counseling Counseling |
Education Evaluation studies Quality of health care |
Additional relevant MeSH terms:
|
Tinnitus Brain Injuries Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013