Cost-effectiveness of Multidisciplinary Management of Tinnitus

May 6, 2013 updated by: Iris Maes, Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

492

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Hoensbroek, Limburg, Netherlands, 6432CC
        • Hoensbroeck Audiological Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjective tinnitus complaints
  • Referred to Tinnitus centre Limburg

Exclusion Criteria:

  • Not being able to write and read in Dutch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At baseline and 3, 8 and 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
At baseline and at 3,8 and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Maastricht University

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 6, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-0012
  • ZonMw 80-007022-98-07715

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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