Cost-effectiveness of Multidisciplinary Management of Tinnitus
- Conditions
- Tinnitus
- Interventions
- Behavioral: Specialized CareOther: Usual Care
- Registration Number
- NCT00733044
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 492
- Subjective tinnitus complaints
- Referred to Tinnitus centre Limburg
- Not being able to write and read in Dutch
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Specialized Care Specialized Care Stepped-care cognitive behavioural approach with elements from tinnitus retraining therapy Usual Care Usual Care Audiological diagnostics and intervention and, if necessary, one or more consultations with a social worker with a maximum of ten one hour session
- Primary Outcome Measures
Name Time Method Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) At baseline and 3, 8 and 12 months follow-up
- Secondary Outcome Measures
Name Time Method Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI) At baseline and at 3, 8 and 12 months follow-up Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ) At baseline and at 3, 8 and 12 months follow-up Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ) At baseline and at 3, 8 and 12 months follow-up 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 Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS). At baseline and at 3, 8 and 12 months follow-up Costs, as measured with a retrospective cost questionnaire At baseline and at 3,8 and 12 months follow-up
Trial Locations
- Locations (1)
Hoensbroeck Audiological Centre
🇳🇱Hoensbroek, Limburg, Netherlands