Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 2
- 主要终点
- Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjective tinnitus complaints
- •Referred to Tinnitus centre Limburg
排除标准
- •Not being able to write and read in Dutch
结局指标
主要结局
Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3)
时间窗: At baseline and 3, 8 and 12 months follow-up
次要结局
- 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)
研究者
Iris Maes
MSc
Maastricht University Medical Center
