Hearing LossNCT00371436
Progressive Intervention Program for Tinnitus Management
A study testing Progressive Audiologic Tinnitus Management in people with Hearing Loss and Tinnitus, run by US Department of Veterans Affairs at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss, Tinnitus
- What is being tested?
- Progressive Audiologic Tinnitus Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Medical Center, Portland
Portland, Oregon, 97201
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612
About this study
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.
Read the detailed description
The 2004 VA Annual Benefits Report reveals that tinnitus is the third most common individual service-connected disability in veterans. As of September 30, 2005, there were 339,573 veterans who had been awarded a service connection for their tinnitus, with annual compensation amounting to over $418,000,000 (Office of Policy and Planning, VA Central Office). In addition to being a major expense for VHA, tinnitus is a health care problem that is inadequately addressed at most VA medical centers. We have developed a research-based model of tinnitus clinical management that is designed for efficient implementation in VA Audiology clinics. The objective of this study is to establish the model program at a VA Audiology clinic, and to evaluate its efficacy with veteran patients and its acceptability to audiologists.
The study is based at the NCRAR, and a prototype tinnitus management program will be established in the Audiology Clinic at the James A. Haley (Tampa) VA Medical Center. 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. It is hypothesized that progressive intervention will result in a significant reduction in self-perceived tinnitus handicap relative to usual care.
A comprehensive web-based tinnitus training course for audiologists has been developed, as well as a patient tinnitus-information book that uses principles of low health literacy. Six audiologists at the Tampa VA are participating in the study, of which three were randomly selected to complete the training course as preparation to conduct each of five levels of progressive intervention: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individualized management. The other three audiologists have not received the training, and these "usual care" audiologists provide intervention that more closely typifies what is done at some VA medical centers.
Patients will be randomized to one of the two groups. All patients will complete outcomes questionnaires (Tinnitus Handicap Inventory [THI] and Veterans Short Form-36 health survey [SF-36V]) at baseline, immediately post-treatment and 6 months post treatment. Outcomes of the THI will be compared between the two groups of patients to test the hypothesis. Data from the SF-36V will be used in secondary outcomes analyses. Each of the six audiologists will be interviewed informally to determine their satisfaction with the tinnitus services that they provide, and how they feel they are meeting the needs of their patients. The three web-based-trained audiologists will provide formative data to the Co-PI on an ongoing basis to monitor and adjust the program to achieve the best possible outcomes.
Development and evaluation of this prototype program will establish its practical utility for addressing the tinnitus needs of veterans in a comprehensive, yet efficient, fashion. If the study shows that the program is effective, then the program could establish the standard for tinnitus management at all VA medical centers-meeting the needs of all veterans who have access to VA services.
- Conditions
- Hearing Loss, Tinnitus
- Being tested
- Progressive Audiologic Tinnitus Management, Usual Care
- Keywords
- Counseling, Education, Evaluation studies, Quality of health care, Rehabilitation of hearing impaired, Triage
- Medical subject headings
- Hearing Loss, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Audiologic Tinnitus ManagementProcedure or surgery
Also called PATM
The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.
Usual CareProcedure or surgery
Also called UC
Typical audiologic care that would be received in a VA Audiology Clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Progressive Audiologic Tinnitus Management |
| Usual Care (UC) | Other | Typical audiologic care that would be received in a VA Audiology Clinic. Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James A Henry, PhD, Principal investigator, VA Medical Center, Portland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371436
- Sponsor's protocol ID
- C4488-R
- Status last verified
- Mar 2015
- First submitted
- 31 Aug 2006
- Last updated
- 8 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20625568Myers 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.
PubMed 25144174
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Intervention Program for Tinnitus Management
- ClinicalTrials.gov ID
- NCT00371436
- Acronym / sponsor ID
- C4488-R
- Conditions
- Hearing Loss, Tinnitus
- Keywords
- Counseling, Education, Evaluation studies, Quality of health care, Rehabilitation of hearing impaired, Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 8 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The 2004 VA Annual Benefits Report reveals that tinnitus is the third most common individual service-connected disability in veterans. As of September 30, 2005, there were 339,573 veterans who had been awarded a service connection for their tinnitus, with annual compensation amounting to over $418,000,000 (Office of Policy and Planning, VA Central Office). In addition to being a major expense for VHA, tinnitus is a health care problem that is inadequately addressed at most VA medical centers. We have developed a research-based model of tinnitus clinical management that is designed for efficient implementation in VA Audiology clinics. The objective of this study is to establish the model program at a VA Audiology clinic, and to evaluate its efficacy with veteran patients and its acceptability to audiologists.
The study is based at the NCRAR, and a prototype tinnitus management program will be established in the Audiology Clinic at the James A. Haley (Tampa) VA Medical Center. 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. It is hypothesized that progressive intervention will result in a significant reduction in self-perceived tinnitus handicap relative to usual care.
A comprehensive web-based tinnitus training course for audiologists has been developed, as well as a patient tinnitus-information book that uses principles of low health literacy. Six audiologists at the Tampa VA are participating in the study, of which three were randomly selected to complete the training course as preparation to conduct each of five levels of progressive intervention: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individualized management. The other three audiologists have not received the training, and these "usual care" audiologists provide intervention that more closely typifies what is done at some VA medical centers.
Patients will be randomized to one of the two groups. All patients will complete outcomes questionnaires (Tinnitus Handicap Inventory [THI] and Veterans Short Form-36 health survey [SF-36V]) at baseline, immediately post-treatment and 6 months post treatment. Outcomes of the THI will be compared between the two groups of patients to test the hypothesis. Data from the SF-36V will be used in secondary outcomes analyses. Each of the six audiologists will be interviewed informally to determine their satisfaction with the tinnitus services that they provide, and how they feel they are meeting the needs of their patients. The three web-based-trained audiologists will provide formative data to the Co-PI on an ongoing basis to monitor and adjust the program to achieve the best possible outcomes.
Development and evaluation of this prototype program will establish its practical utility for addressing the tinnitus needs of veterans in a comprehensive, yet efficient, fashion. If the study shows that the program is effective, then the program could establish the standard for tinnitus management at all VA medical centers-meeting the needs of all veterans who have access to VA services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Audiologic Tinnitus Management (PATM) | Active comparator | Procedure: Progressive Audiologic Tinnitus ManagementThe 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. |
| Usual Care (UC) | Other | Procedure: Usual CareTypical audiologic care that would be received in a VA Audiology Clinic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Audiologic Tinnitus ManagementAlso: PATMThe five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management. | Procedure or surgery | Progressive Audiologic Tinnitus Management (PATM) |
| Usual CareAlso: UCTypical audiologic care that would be received in a VA Audiology Clinic. | Procedure or surgery | Usual Care (UC) |
Primary outcome
THI (Tinnitus Handicap Inventory)
Time frame: Baseline, 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20625568Henry 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.
- Results publication: PubMed 25144174Myers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Henry, PhD principal investigator
VA Medical Center, Portland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Audiologic Tinnitus Management in people with Hearing Loss and Tinnitus, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THI (Tinnitus Handicap Inventory) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371436, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.