Tinnitus Clinical Trial
Official title:
Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the
general population. Among severe sufferers it causes disability in various areas. As a
result of the tinnitus quality of life is often impaired. At present there is no cure or
uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence
suggests an integral multidisciplinary approach in treating tinnitus is effective. The main
objective of this study is to examine the effectiveness, costs, and cost-effectiveness of an
integral treatment provided by a specialized tinnitus center versus usual care. This paper
describes the study protocol.
Methods/Design: In a randomized controlled clinical trial 198 tinnitus patients will be
randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus
sufferers referred to the audiological centre are eligible. Included patients will be
followed for 12 months.
Primary outcome measure is generic quality of life (measured with the Health Utilities Index
Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus
cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data
the number of patients to include is 198. Economic evaluation will be from a societal
perspective.
Discussion/ Conclusion: This is, to our knowledge, the first randomized controlled trial
that evaluates an integral treatment of tinnitus that includes a full economic evaluation
from a societal perspective. If this intervention proves to be effective and cost-effective,
implementation of this intervention is considered and anticipated.
Status | Completed |
Enrollment | 492 |
Est. completion date | July 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjective tinnitus complaints - Referred to Tinnitus centre Limburg Exclusion Criteria: - Not being able to write and read in Dutch |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Netherlands | Hoensbroeck Audiological Centre | Hoensbroek | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Maastricht University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) | At baseline and 3, 8 and 12 months follow-up | No | |
Secondary | Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI) | At baseline and at 3, 8 and 12 months follow-up | No | |
Secondary | Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ) | At baseline and at 3, 8 and 12 months follow-up | No | |
Secondary | Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ) | At baseline and at 3, 8 and 12 months follow-up | No | |
Secondary | Dysfunctional beliefs and/or cognitions regarding the tinnitus, as measured with the Tinnitus Coping and Cognition list (TCCL) | At baseline and at 3, 8 and 12 months follow-up | No | |
Secondary | Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS). | At baseline and at 3, 8 and 12 months follow-up | No | |
Secondary | Costs, as measured with a retrospective cost questionnaire | At baseline and at 3,8 and 12 months follow-up | No |
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