Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
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.


Options:
A: Arm Label: Group 1 : G_1; Type: ACTIVE_COMPARATOR; Interventions: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset | Arm Label: Group 2 :G_2; Type: ACTIVE_COMPARATOR; Interventions: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset | Arm Label: Group3 : G_3; Type: ACTIVE_COMPARATOR; Interventions: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset | Arm Label: Group 4 : G_4; Type: ACTIVE_COMPARATOR; Interventions: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset | Arm Label: Group5 : G_5; Type: PLACEBO_COMPARATOR; Interventions: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset | Intervention Type: DEVICE; Name: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset; Assigned to Arm(s): Group 1 : G_1, Group 2 :G_2, Group 4 : G_4, Group3 : G_3, Group5 : G_5
B: Arm Label: Specialized Care; Type: EXPERIMENTAL; Interventions: Behavioral: Specialized Care | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual Care | Intervention Type: BEHAVIORAL; Name: Specialized Care; Assigned to Arm(s): Specialized Care | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Usual Care
C: Arm Label: STAR2; Type: ACTIVE_COMPARATOR; Interventions: Other: reactive auditory training | Arm Label: Treasure Hunter; Type: EXPERIMENTAL; Interventions: Other: Interactive auditory training | Arm Label: Submarine; Type: EXPERIMENTAL; Interventions: Other: Interactive auditory training | Intervention Type: OTHER; Name: reactive auditory training; Assigned to Arm(s): STAR2 | Intervention Type: OTHER; Name: Interactive auditory training; Assigned to Arm(s): Submarine, Treasure Hunter
D: Arm Label: control; Type: OTHER; Interventions: Device: hearing aids with only amplification | Arm Label: sound generator; Type: EXPERIMENTAL; Interventions: Device: sound generator | Intervention Type: DEVICE; Name: sound generator; Assigned to Arm(s): sound generator | Intervention Type: DEVICE; Name: hearing aids with only amplification; Assigned to Arm(s): control

Answer: B