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Cost-effectiveness of Multidisciplinary Management of Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Specialized Care
Usual Care
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tinnitus focused on measuring Objective tinnitus, Tinnitus, RCT, Specialised treatment, Usual care, Cost-effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjective tinnitus complaints
  • Referred to Tinnitus centre Limburg

Exclusion Criteria:

  • Not being able to write and read in Dutch

Sites / Locations

  • Hoensbroeck Audiological Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Specialized Care

Usual Care

Arm Description

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

Audiological diagnostics and intervention and, if necessary, one or more consultations with a social worker with a maximum of ten one hour session

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI)
Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ)
Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ)
Dysfunctional beliefs and/or cognitions regarding the tinnitus, as measured with the Tinnitus Coping and Cognition list (TCCL)
Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS).
Costs, as measured with a retrospective cost questionnaire

Full Information

First Posted
August 7, 2008
Last Updated
May 6, 2013
Sponsor
Maastricht University Medical Center
Collaborators
Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT00733044
Brief Title
Cost-effectiveness of Multidisciplinary Management of Tinnitus
Official Title
Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Maastricht University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Objective tinnitus, Tinnitus, RCT, Specialised treatment, Usual care, Cost-effectiveness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
492 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specialized Care
Arm Type
Experimental
Arm Description
Stepped-care cognitive behavioural approach with elements from tinnitus retraining therapy
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Audiological diagnostics and intervention and, if necessary, one or more consultations with a social worker with a maximum of ten one hour session
Intervention Type
Behavioral
Intervention Name(s)
Specialized Care
Other Intervention Name(s)
Multidisciplinary care
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ)
Time Frame
At baseline and at 3, 8 and 12 months follow-up
Title
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
Title
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
Title
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
Title
Costs, as measured with a retrospective cost questionnaire
Time Frame
At baseline and at 3,8 and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjective tinnitus complaints Referred to Tinnitus centre Limburg Exclusion Criteria: Not being able to write and read in Dutch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan WS Vlaeyen, Prof, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuela A Joore, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucien J Anteunis, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoensbroeck Audiological Centre
City
Hoensbroek
State/Province
Limburg
ZIP/Postal Code
6432CC
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22633033
Citation
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.
Results Reference
derived
PubMed Identifier
19210767
Citation
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.
Results Reference
derived

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Cost-effectiveness of Multidisciplinary Management of Tinnitus

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