Trial Outcomes & Findings for Telephone Tinnitus Education for Patients With Traumatic Brain Injury (TBI) (NCT NCT01129141)

Last Updated: 2017-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

205 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2017-01-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	101	104
Overall Study COMPLETED	86	91
Overall Study NOT COMPLETED	15	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tele-PTM n=101 Participants 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 n=104 Participants 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.	Total n=205 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants	73 Participants n=7 Participants	138 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants
Age, Continuous	60.24 years STANDARD_DEVIATION 10.18 • n=5 Participants	57.92 years STANDARD_DEVIATION 10.71 • n=7 Participants	59.07 years STANDARD_DEVIATION 10.49 • n=5 Participants
Gender Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Gender Male	87 Participants n=5 Participants	88 Participants n=7 Participants	175 Participants n=5 Participants
Region of Enrollment United States	101 Participants n=5 Participants	104 Participants n=7 Participants	205 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

Outcome measures

Outcome measures
Measure	Tele-PTM n=101 Participants 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 n=104 Participants 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 Baseline	69.9 units on a scale Standard Deviation 15.3	68.2 units on a scale Standard Deviation 18.7
Tinnitus Functional Index 6 months	47.8 units on a scale Standard Deviation 21.8	66.8 units on a scale Standard Deviation 18.3

Adverse Events

Tele-PTM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James A. Henry, Ph.D.

NCRAR, VA RR&D

Phone: 503.220.8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place