N/A
N=205
Telephone Tinnitus Education for Patients With Traumatic Brain Injury (TBI)
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT01129141 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Tinnitus Functional Index — 69.9; 68.2; 47.8; 66.8 units on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tele-PTM (Procedure); Wait List Control (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinnitus Functional Index |
69.9; 68.2; 47.8; 66.8 | <.0001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01129141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.