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Trial Outcomes & Findings for Progressive Intervention Program for Tinnitus Management (NCT NCT00371436)

NCT ID: NCT00371436

Last Updated: 2015-04-08

Results Overview

The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

181 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2015-04-08

Participant Flow

Participant milestones

Participant milestones
Measure
Tinnitus Progressive Management
Tinnitus Progressive Management: The program follows a five-level "progressive intervention" model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.
Usual Care
Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
Overall Study
STARTED
92
89
Overall Study
COMPLETED
58
68
Overall Study
NOT COMPLETED
34
21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Progressive Intervention Program for Tinnitus Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tinnitus Progressive Management
n=92 Participants
Tinnitus Progressive Management: The program follows a five-level "progressive intervention" model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.
Usual Care
n=89 Participants
Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
Total
n=181 Participants
Total of all reporting groups
Age, Continuous
56.0 years
STANDARD_DEVIATION 11.2 • n=99 Participants
59.0 years
STANDARD_DEVIATION 10.5 • n=107 Participants
57.5 years
STANDARD_DEVIATION 10.8 • n=206 Participants
Sex: Female, Male
Female
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Sex: Female, Male
Male
89 Participants
n=99 Participants
87 Participants
n=107 Participants
176 Participants
n=206 Participants
Region of Enrollment
United States
92 participants
n=99 Participants
89 participants
n=107 Participants
181 participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The THI was completed by 58 of the 92 PATM patients at both baseline and 6 months. The THI was completed by 68 of the 89 Usual Care patients at both baseline and 6 months.

The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap.

Outcome measures

Outcome measures
Measure
Arm 1
n=58 Participants
Tinnitus Progressive Management Tinnitus Progressive Management: The program follows a five-level "progressive intervention" model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.
Arm 2
n=68 Participants
Usual Care Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
THI (Tinnitus Handicap Inventory)
Baseline
37.0 scores on a scale
Standard Deviation 24.3
43.0 scores on a scale
Standard Deviation 25.4
THI (Tinnitus Handicap Inventory)
6 months
33.0 scores on a scale
Standard Deviation 26.4
40.0 scores on a scale
Standard Deviation 27.6

Adverse Events

Tinnitus Progressive Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Usual Care

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.

VA RR&D, NCRAR

Phone: 5032208262

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place