An interventional study of Tele-PTM and Wait List Control in Tinnitus, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-26.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's enrollment of 205 is above the median of 60 across 339 interventional studies indexed under Tinnitus.
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Inclusion Criteria:
Inclusion criteria include:
Exclusion Criteria:
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
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
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.
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.
Time frame: Baseline, 6 months
Potential participants (candidates) were referred to the study by fliers posted at U.S. VA and Military sites. Civilians were not actively recruited for the study, but some discovered it via clinicaltrials.gov or by word of mouth. Candidates contacted the study team and were screened for potential eligibility over the phone.
| Milestone | Tele-PTM | Wait List Control |
|---|---|---|
| Started | 101 | 104 |
| Completed | 86 | 91 |
| Not completed | 15 | 13 |
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.
| units on a scale | Tele-PTM | Wait List Control |
|---|---|---|
| Baseline | 69.9 ± 15.3 | 68.2 ± 18.7 |
| 6 months | 47.8 ± 21.8 | 66.8 ± 18.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tele-PTM | — | 0/101 (0%) | 0/101 (0%) |
| Wait List Control | — | 0/104 (0%) | 0/104 (0%) |
| Age, Categorical(Participants) | Tele-PTM | Wait List Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 65 | 73 | 138 |
| >=65 years | 36 | 31 | 67 |
| Age, Continuous(years) | Tele-PTM | Wait List Control | Total |
|---|---|---|---|
| Mean | 60.24 ± 10.18 | 57.92 ± 10.71 | 59.07 ± 10.49 |
| Gender(Participants) | Tele-PTM | Wait List Control | Total |
|---|---|---|---|
| Female | 14 | 16 | 30 |
| Male | 87 | 88 | 175 |
| Region of Enrollment(Participants) | Tele-PTM | Wait List Control | Total |
|---|---|---|---|
| United States | 101 | 104 | 205 |
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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