Tinnitus
Conditions
Keywords
Tinnitus, Traumatic Brain Injury Counseling, Counseling, Education, Evaluation studies, Quality of health care
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.
Interventions
PROCEDURETele-PTM
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.
PROCEDUREWait List Control
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Functional Index | Baseline, 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Candidates must have had a hearing test within the previous 2 years. They were required to get hearing aids if recommended and wear them for at least 1 month before entering the study. Consented candidates were assessed for phone counseling suitability. If current suicidal ideation (SI) was expressed, the subject was excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Tele-PTM 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. | 101 |
| Wait List Control 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. | 104 |
| Total | 205 |
Baseline characteristics
| Characteristic | Wait List Control | Tele-PTM | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 36 Participants | 67 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 65 Participants | 138 Participants |
| Age, Continuous | 57.92 years STANDARD_DEVIATION 10.71 | 60.24 years STANDARD_DEVIATION 10.18 | 59.07 years STANDARD_DEVIATION 10.49 |
| Gender Female | 16 Participants | 14 Participants | 30 Participants |
| Gender Male | 88 Participants | 87 Participants | 175 Participants |
| Region of Enrollment United States | 104 Participants | 101 Participants | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 101 | 0 / 104 |
| serious Total, serious adverse events | 0 / 101 | 0 / 104 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-PTM | Tinnitus Functional Index | 6 months | 47.8 units on a scale | Standard Deviation 21.8 |
| Tele-PTM | Tinnitus Functional Index | Baseline | 69.9 units on a scale | Standard Deviation 15.3 |
| Wait List Control | Tinnitus Functional Index | 6 months | 66.8 units on a scale | Standard Deviation 18.3 |
| Wait List Control | Tinnitus Functional Index | Baseline | 68.2 units on a scale | Standard Deviation 18.7 |
p-value: <0.000195% CI: [-22.86, -11.53]Mixed Models Analysis