The CATT Trial: Cost-effectiveness of a Smartphone Application for Tinnitus Treatment
NCT ID: NCT05245318
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
334 participants
INTERVENTIONAL
2022-03-01
2025-12-01
Brief Summary
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Detailed Description
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Objective: The twofold aim of this study is to examine if the treatment effect and cost-effectiveness of a smartphone application, designed to increase therapy compliance and provide tinnitus counselling, as part of a blended physiotherapy program, is, as hypothesised, as good as or better in comparison to standard clinical care.
Methods and design: This study is designed as a single-blind two-arm 1:1 randomised control trial. Adult patients diagnosed with ST, without psychiatric comorbidities and with basic knowledge of the use of a smartphone, will be recruited at the Ear Nose Throat (ENT) department of the Antwerp university hospital (UZA). After inclusion and baseline measurements, patients will be randomised to one of the treatment groups. The experimental group will receive the blended physiotherapy program containing six in-clinic physiotherapy sessions over a period of twelve weeks (1x/2weeks) and access to the exercise and counselling program provided by the smartphone application. The control group will receive the standard care physiotherapy program comprising twelve weekly in-clinic physiotherapy sessions. As a primary outcome measure, the change in Tinnitus Functional Index (TFI) score at 1 month after the last treatment will be used. Secondary outcome measures are the visual analogue scale (VAS) for tinnitus loudness, Neck Bournemouth Questionnaire (NBQ), Temporomandibular disorder (TMD) pain screener, clinical neck and jaw tests, pure tone audiometry, speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding, psychoacoustic tinnitus measures (tinnitus pitch and loudness matching), the Hospital Anxiety and Depression Scale (HADS), the Hyperacusis Questionnaire (HQ). Additionally, a cost-effectiveness analysis will be performed informing on both medical costs and indirect costs. Data from the Euroqol EQ-5D and iMTA Productivity Cost Questionnaire (PCQ) will be used in this analysis. Data for all outcome measures will be collected at baseline, one month after the last treatment session and three months after the last treatment session.
Discussion: This is the first study to combine both tinnitus counselling and neck/jaw pain treatment provided by a digital application in a blended physiotherapy program. This is in order to empower ST patients to improve and better manage their own health and possibly reduce economic costs by alleviating the tinnitus burden ST patients experience. The advantages of this single-blind two-arm randomised controlled trial are the high-quality methodological design, the great sample size and the expertise of the research team.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard clinical care control group
Standard physiotherapy program of 12 weeks (1 treatment session /week)
Standard Clinical care
The standard care treatment comprises 12 face-to-face individual physiotherapy sessions at a ratio of 1 session a week. Every patient in the control group will be treated in a tailored manner according to their results on the baseline measurements. The multimodal treatment program will consist of exercises to increase strength, endurance and coordination of the cervical spine and shoulder stabilising muscles, exercises to increase mobility and improve posture. In case of jaw complaints stretching exercises of the masticatory muscles are added to the program. In addition, manual mobilisations and manual techniques to decrease muscle tension in neck and jaw muscles can be added to the exercise program if necessary. Patients will receive counselling to learn about their neck/jaw complaints but no tinnitus counselling. Patients will be motivated to perform the exercise program at home on a daily basis. Patients will be evaluated weekly.
Experimental blended physiotherapy program group
Blended physiotherapy program of 12 weeks with exercises and counselling provided through a smartphone application and 6 face-to-face treatment sessions (1 physiotherapy treatment session every 2 weeks)
Blended physiotherapy program
The experimental group will receive a blended physiotherapy program consisting of six physiotherapy treatments over a period of 12 weeks, meaning one treatment session every two weeks. In addition, a smartphone application will offer the patients a daily exercise program, based upon the standard physiotherapy treatment, and psychological counselling. Before the start of the program, the exercises will be tailored to the area, type and degree of the patient's dysfunctions. During the six physiotherapy treatment sessions patients will (if needed), receive additional manual mobilisations to increase mobility of the neck and/or temporomandibular joints or manual techniques to decrease muscle tension in neck and jaw muscles. Additional counselling on knowledge about neck and jaw pain and advice about good posture and movement habits will also be provided by the physiotherapist during these six treatment sessions.
Interventions
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Standard Clinical care
The standard care treatment comprises 12 face-to-face individual physiotherapy sessions at a ratio of 1 session a week. Every patient in the control group will be treated in a tailored manner according to their results on the baseline measurements. The multimodal treatment program will consist of exercises to increase strength, endurance and coordination of the cervical spine and shoulder stabilising muscles, exercises to increase mobility and improve posture. In case of jaw complaints stretching exercises of the masticatory muscles are added to the program. In addition, manual mobilisations and manual techniques to decrease muscle tension in neck and jaw muscles can be added to the exercise program if necessary. Patients will receive counselling to learn about their neck/jaw complaints but no tinnitus counselling. Patients will be motivated to perform the exercise program at home on a daily basis. Patients will be evaluated weekly.
Blended physiotherapy program
The experimental group will receive a blended physiotherapy program consisting of six physiotherapy treatments over a period of 12 weeks, meaning one treatment session every two weeks. In addition, a smartphone application will offer the patients a daily exercise program, based upon the standard physiotherapy treatment, and psychological counselling. Before the start of the program, the exercises will be tailored to the area, type and degree of the patient's dysfunctions. During the six physiotherapy treatment sessions patients will (if needed), receive additional manual mobilisations to increase mobility of the neck and/or temporomandibular joints or manual techniques to decrease muscle tension in neck and jaw muscles. Additional counselling on knowledge about neck and jaw pain and advice about good posture and movement habits will also be provided by the physiotherapist during these six treatment sessions.
Eligibility Criteria
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Inclusion Criteria
* Fluent in Dutch
* Own smartphone and able to use common applications without support
Exclusion Criteria
* Active middle ear pathology
* An active psychiatric disorder (such as anxiety disorder or clinical depression) diagnosed by the psychiatric team of Antwerp University Hospital
18 Years
ALL
No
Sponsors
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Universiteit Antwerpen
OTHER
University Hospital, Antwerp
OTHER
University of Regensburg
OTHER
Hasselt University
OTHER
Responsible Party
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Sarah Michiels
Prof. Dr.
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Demoen S, Jacquemin L, Timmermans A, Van Rompaey V, Vanderveken O, Vermeersch H, Joossen I, Van Eetvelde J, Schlee W, Marneffe W, Luyten J, Gilles A, Michiels S. Cost-effectiveness of a smartphone Application for Tinnitus Treatment (the CATT trial): a study protocol of a randomised controlled trial. Trials. 2022 May 23;23(1):435. doi: 10.1186/s13063-022-06378-7.
Other Identifiers
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T002221N
Identifier Type: -
Identifier Source: org_study_id
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