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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01129141
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : November 23, 2016
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tinnitus
Interventions Procedure: Tele-PTM
Procedure: Wait List Control
Enrollment 205
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.
Arm/Group Title Tele-PTM Wait List Control
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 101 104
Completed 86 91
Not Completed 15 13
Arm/Group Title Tele-PTM Wait List Control Total
Hide Arm/Group Description 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. Total of all reporting groups
Overall Number of Baseline Participants 101 104 205
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 104 participants 205 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
65
  64.4%
73
  70.2%
138
  67.3%
>=65 years
36
  35.6%
31
  29.8%
67
  32.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 104 participants 205 participants
60.24  (10.18) 57.92  (10.71) 59.07  (10.49)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 104 participants 205 participants
Female
14
  13.9%
16
  15.4%
30
  14.6%
Male
87
  86.1%
88
  84.6%
175
  85.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 101 participants 104 participants 205 participants
101
 100.0%
104
 100.0%
205
 100.0%
1.Primary Outcome
Title Tinnitus Functional Index
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tele-PTM Wait List Control
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 101 104
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 69.9  (15.3) 68.2  (18.7)
6 months 47.8  (21.8) 66.8  (18.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tele-PTM, Wait List Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.198
Confidence Interval (2-Sided) 95%
-22.86 to -11.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.88
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tele-PTM Wait List Control
Hide Arm/Group Description 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.
All-Cause Mortality
Tele-PTM Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tele-PTM Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/104 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tele-PTM Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/104 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James A. Henry, Ph.D.
Organization: NCRAR, VA RR&D
Phone: 503.220.8262 ext 57466
EMail: james.henry@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01129141    
Other Study ID Numbers: C7452-I
First Submitted: May 20, 2010
First Posted: May 24, 2010
Results First Submitted: October 3, 2016
Results First Posted: November 23, 2016
Last Update Posted: January 26, 2017