Cost-effectiveness of Multidisciplinary Management of Tinnitus

Tinnitus Clinical Trial

Official title:

Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733044
• Other study ID #: 06-0012
• Secondary ID: ZonMw 80-007022-
• Status: Completed
• Phase: N/A
• First received: August 7, 2008
• Last updated: May 6, 2013
• Start date: September 2007
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: July 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjective tinnitus complaints

• Referred to Tinnitus centre Limburg

Exclusion Criteria:

• Not being able to write and read in Dutch

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tinnitus

Intervention

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:
• 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.

Locations

Country	Name	City	State
Netherlands	Hoensbroeck Audiological Centre	Hoensbroek	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3)		At baseline and 3, 8 and 12 months follow-up	No
Secondary	Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI)		At baseline and at 3, 8 and 12 months follow-up	No
Secondary	Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ)		At baseline and at 3, 8 and 12 months follow-up	No
Secondary	Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ)		At baseline and at 3, 8 and 12 months follow-up	No
Secondary	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	No
Secondary	Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS).		At baseline and at 3, 8 and 12 months follow-up	No
Secondary	Costs, as measured with a retrospective cost questionnaire		At baseline and at 3,8 and 12 months follow-up	No