NCT00371436

Brief Summary

The purpose of this multi-site randomized clinical study is to test a model treatment program in a VA Audiology clinic, to evaluate its efficacy, ease of implementation, and acceptability to audiologists.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

April 8, 2015

Completed
Last Updated

April 8, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

August 31, 2006

Results QC Date

November 13, 2014

Last Update Submit

March 24, 2015

Conditions

Hearing LossTinnitus

Keywords

CounselingEducationEvaluation studiesQuality of health careRehabilitation of hearing impairedTriage

Outcome Measures

Primary Outcomes (1)

  • THI (Tinnitus Handicap Inventory)

    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.

    Baseline, 6 months

Study Arms (2)

Progressive Audiologic Tinnitus Management (PATM)

ACTIVE COMPARATOR

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.

Procedure: Progressive Audiologic Tinnitus Management

Usual Care (UC)

OTHER

Typical audiologic care that would be received in a VA Audiology Clinic.

Procedure: Usual Care

Interventions

Progressive Audiologic Tinnitus ManagementPROCEDURE

The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.

Also known as: PATM
Progressive Audiologic Tinnitus Management (PATM)
Usual CarePROCEDURE

Typical audiologic care that would be received in a VA Audiology Clinic.

Also known as: UC
Usual Care (UC)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans who:
  • Are outpatients at VA clinics in the vicinity of the James A. Haley VA Medical Center in Tampa, FL
  • Have clinically significant tinnitus
  • Have no significant language barrier
  • Are capable of and willing to fulfill all study requirements

You may not qualify if:

  • Subjects must be free from any medical conditions that would interfere with study participation, e.g. medically or surgically treatable otologic disease; end-stage renal, pulmonary, or cardiovascular disease
  • Patients undergoing chemotherapy or radiation treatment
  • Patients with severe psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, 33612, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

Related Publications (2)

  • Henry JA, Zaugg TL, Myers PJ, Kendall CJ, Michaelides EM. A triage guide for tinnitus. J Fam Pract. 2010 Jul;59(7):389-93. No abstract available.

    PMID: 20625568RESULT

  • Myers PJ, Griest S, Kaelin C, Legro MW, Schmidt CJ, Zaugg TL, Henry JA. Development of a progressive audiologic tinnitus management program for Veterans with tinnitus. J Rehabil Res Dev. 2014;51(4):609-22. doi: 10.1682/JRRD.2013.08.0189.

    PMID: 25144174RESULT

MeSH Terms

Conditions

Hearing LossTinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
James A. Henry, Ph.D.
Organization
VA RR&D, NCRAR
james.henry@va.gov
5032208262

Study Officials

  • James A Henry, PhD

    VA Medical Center, Portland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

April 8, 2015

Results First Posted

April 8, 2015

Record last verified: 2015-03

Locations

US(2)