Cost-effectiveness of Multidisciplinary Management of Tinnitus
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|ClinicalTrials.gov Identifier: NCT00733044|
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : May 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Behavioral: Specialized Care Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||492 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||July 2012|
Experimental: Specialized Care
Stepped-care cognitive behavioural approach with elements from tinnitus retraining therapy
Behavioral: Specialized Care
The intervention consists of the integration of integral tinnitus management provided by a specialized tinnitus centre in the health care system. The tinnitus centre offers care following a stepped-care approach with two levels. The first level of intervention consists of audiological diagnostics and intervention, a tinnitus educational group session and a individual consult with a clinical psychologist. For patients with mild complaints this basic intervention is expected to suffice. For patients with moderate to severe complaints a second level of intervention exists. This level of intervention consists of combinations of the following therapies: Cognitive Behavioural Therapy (CBT), Attention Diversion (AD), exposure techniques, and Relaxation Therapy (RT).
Other Name: Multidisciplinary care
Active Comparator: 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
Other: Usual Care
Usual care consists of a standardized version of treatment that is currently applied in peripheral audiological centres throughout the Netherlands. A telephone survey was conducted amongst all audiological centres (n=28) in the Netherlands. The results of this survey determined the content of the usual care treatment protocol in the current study. The treatment consists of audiological diagnostics and intervention and, if necessary, one or more consults with a social worker with a maximum of ten one hour sessions.
- Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) [ Time Frame: At baseline and 3, 8 and 12 months follow-up ]
- Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI) [ Time Frame: At baseline and at 3, 8 and 12 months follow-up ]
- Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ) [ Time Frame: At baseline and at 3, 8 and 12 months follow-up ]
- Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ) [ Time Frame: 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) [ Time Frame: At baseline and at 3, 8 and 12 months follow-up ]
- Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS). [ Time Frame: At baseline and at 3, 8 and 12 months follow-up ]
- Costs, as measured with a retrospective cost questionnaire [ Time Frame: At baseline and at 3,8 and 12 months follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733044
|Hoensbroeck Audiological Centre|
|Hoensbroek, Limburg, Netherlands, 6432CC|
|Principal Investigator:||Johan WS Vlaeyen, Prof, PhD||Maastricht University|
|Principal Investigator:||Manuela A Joore, PhD||Maastricht University Medical Center|
|Principal Investigator:||Lucien J Anteunis, PhD||Maastricht University Medical Center|