Cost-effectiveness of Multidisciplinary Management of Tinnitus

NCT00733044 | Completed

• 2 other identifiers: 06-0012ZonMw 80-007022-98-07715
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Objective tinnitus; Tinnitus; RCT; Specialised treatment; Usual care; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3)

  At baseline and 3, 8 and 12 months follow-up

Secondary Outcomes (6)

• Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI)

  At baseline and at 3, 8 and 12 months follow-up

• Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ)

  At baseline and at 3, 8 and 12 months follow-up

• Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ)

  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)

  At baseline and at 3, 8 and 12 months follow-up

• Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS).

  At baseline and at 3, 8 and 12 months follow-up

Study Arms (2)

Specialized Care

EXPERIMENTAL

Stepped-care cognitive behavioural approach with elements from tinnitus retraining therapy

Behavioral: Specialized Care

Usual Care

ACTIVE COMPARATOR

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

Interventions

Specialized Care BEHAVIORAL

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).

Also known as: Multidisciplinary care

Specialized Care

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjective tinnitus complaints
• Referred to Tinnitus centre Limburg

You may not qualify if:

• Not being able to write and read in Dutch

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Maastricht University: collaborator

Study Sites (1)

Hoensbroeck Audiological Centre

Hoensbroek, Limburg, 6432CC, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 22633033 DERIVED

• 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.

  PMID: 19210767 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Patient Care Team

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 12, 2008
• Study Start: September 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2012
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

NL (1)