Clinical trial NCT00733044: Cost-effectiveness of Multidisciplinary Management of Tinnitus
Official title: Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Objective tinnitus
Tinnitus
RCT
Specialised treatment
Usual care
Cost-effectiveness
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2008-08-12
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Subjective tinnitus complaints
* Referred to Tinnitus centre Limburg

Exclusion Criteria:

* Not being able to write and read in Dutch

Primary outcomes:
measure: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3)
timeFrame: At baseline and 3, 8 and 12 months follow-up
Secondary outcomes:
measure: Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI)
timeFrame: At baseline and at 3, 8 and 12 months follow-up
measure: Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ)
timeFrame: At baseline and at 3, 8 and 12 months follow-up
measure: Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ)
timeFrame: At baseline and at 3, 8 and 12 months follow-up
measure: Dysfunctional beliefs and/or cognitions regarding the tinnitus, as measured with the Tinnitus Coping and Cognition list (TCCL)
timeFrame: At baseline and at 3, 8 and 12 months follow-up
measure: Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS).
timeFrame: At baseline and at 3, 8 and 12 months follow-up
measure: Costs, as measured with a retrospective cost questionnaire
timeFrame: At baseline and at 3,8 and 12 months follow-up
Other outcomes:
Locations:
city: Hoensbroek
country: Netherlands
facility: Hoensbroeck Audiological Centre
state: Limburg
Study officials:
affiliation: Maastricht University
name: Johan WS Vlaeyen, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Manuela A Joore, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Lucien J Anteunis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.
citation: Cima R, Joore M, Maes I, Scheyen D, Refaie AE, Baguley DM, Vlaeyen JW, Anteunis L. Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre. BMC Health Serv Res. 2009 Feb 11;9:29. doi: 10.1186/1472-6963-9-29.