Cost-effectiveness of Multidisciplinary Management of Tinnitus

This study has been completed.
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Iris Maes, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00733044
First received: August 7, 2008
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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 Intervention
Tinnitus
Behavioral: Specialized Care
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ) [ Time Frame: At baseline and at 3, 8 and 12 months follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Costs, as measured with a retrospective cost questionnaire [ Time Frame: At baseline and at 3,8 and 12 months follow-up ] [ Designated as safety issue: No ]

Enrollment: 492
Study Start Date: September 2007
Study Completion Date: July 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjective tinnitus complaints
  • Referred to Tinnitus centre Limburg

Exclusion Criteria:

  • Not being able to write and read in Dutch
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733044

Locations
Netherlands
Hoensbroeck Audiological Centre
Hoensbroek, Limburg, Netherlands, 6432CC
Sponsors and Collaborators
Maastricht University Medical Center
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
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Iris Maes, MSc, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00733044     History of Changes
Other Study ID Numbers: 06-0012, ZonMw 80-007022-98-07715
Study First Received: August 7, 2008
Last Updated: May 6, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Objective tinnitus
Tinnitus
RCT
Specialised treatment
Usual care
Cost-effectiveness

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014