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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01129141
First received: May 20, 2010
Last updated: November 30, 2016
Last verified: November 2016
Results First Received: October 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tinnitus
Interventions: Procedure: Tele-PTM
Procedure: Wait List Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Tele-PTM   Wait List Control
STARTED   101   104 
COMPLETED   86   91 
NOT COMPLETED   15   13 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Tele-PTM   Wait List Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   104   205 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 60.24  (10.18)   57.92  (10.71)   59.07  (10.49) 
Gender 
[Units: Participants]
Count of Participants
     
Female      14  13.9%      16  15.4%      30  14.6% 
Male      87  86.1%      88  84.6%      175  85.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   101   104   205 


  Outcome Measures

1.  Primary:   Tinnitus Functional Index   [ Time Frame: Baseline, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: James A. Henry, Ph.D.
Organization: NCRAR, VA RR&D
phone: 503.220.8262 ext 57466
e-mail: james.henry@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01129141     History of Changes
Other Study ID Numbers: C7452-I
Study First Received: May 20, 2010
Results First Received: October 3, 2016
Last Updated: November 30, 2016