Cost-effectiveness of a Smartphone Application for Tinnitus Treatment (The CATT Trial): A Study Protocol of a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- Change in Tinnitus Functional Index (TFI)
研究概览
简要总结
The twofold aim of this single-blind two-arm 1:1 randomised control trial 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.
详细描述
Background: Tinnitus is a highly prevalent symptom with a variety of possible underlying diseases, affecting 10-15% of the adult population. Apart from the heterogenous clinical origin, it is also characterised by a diverse clinical representation, often causing distress and interfering with daily functioning and quality of life. In case the tinnitus is influenced by alterations in somatosensory afference from the cervical spine or temporomandibular area, due to increased muscle tension or movement restrictions, it is referred to as somatic or somatosensory tinnitus (ST). ST is known to react well to physiotherapy treatment, but currently, it is hard to motivate patients to do their home exercises properly and the necessary tinnitus counselling is often lacking.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study patients will be blinded towards the group they will be randomised to, but the therapist cannot be blinded, as she knows whether a patient receives the treatment every week or every two weeks. To limit the risk of bias related to lack of blinding of the therapist, all evaluation measurements will be performed by a blinded assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (+ 18 years old) with Somatic tinnitus (ST), diagnosed according to the diagnostic criteria for ST
- •Fluent in Dutch
- •Own smartphone and able to use common applications without support
排除标准
- •Other types of tinnitus
- •Active middle ear pathology
- •An active psychiatric disorder (such as anxiety disorder or clinical depression) diagnosed by the psychiatric team of Antwerp University Hospital
结局指标
主要结局
Change in Tinnitus Functional Index (TFI)
时间窗: from baseline to one month follow-up (also tested after last treatment session and at three months follow-up)
The primary outcome is the change in Tinnitus functional index (TFI) score from baseline to one month after the treatment. This timepoint was chosen since previous research indicated that the largest treatment effect on TFI is to be expected four to seven weeks after the last treatment session. The TFI is a self-report questionnaire comprising 25 questions, each scored by an eleven-point Likert scale, objectifying the impact and severity of tinnitus. Eight subscores are differentiated, namely intrusiveness, sense of control, cognitive complaints, sleep disturbance, auditory difficulties, relaxation, quality of life (QOL) and emotional distress. The total score and subscores are noted on a scale of 0 to 100. Higher scores indicate higher levels of tinnitus-related distress. TFI has a good test-retest reliability (r: 0.78), discriminant validity with the Beck Depression Inventory-Primary Care (r: 0.56) and convergent validity with the Tinnitus Handicap Inventory (THI) (r: 0.86).
次要结局
- Cervical spine mobility(from baseline to one and three months follow-up)
- Coordination of deep neck extensors(from baseline to one and three months follow-up)
- Coordination of shoulder stabilizing muscles(from baseline to one and three months follow-up)
- Myofascial triggerpoints(from baseline to one and three months follow-up)
- Speech-in-noise (SPIN) understanding(from baseline to one and three months follow-up)
- Joint Repositioning Accuracy (JRA)(from baseline to one and three months follow-up)
- Hyperacusis Questionnaire (HQ)(from baseline to one and three months follow-up)
- Speech-in-quiet (SPIQ) understanding(from baseline to one and three months follow-up)
- VAS for tinnitus loudness(from baseline to one and three months follow-up)
- Temporomandibular disorder (TMD) pain screener score(from baseline to one and three months follow-up)
- Productivity Cost Questionnaire (iPCQ)(monthly between baseline and three months follow-up)
- Strength of deep neck flexors(from baseline to one and three months follow-up)
- Jaw mobility(from baseline to one and three months follow-up)
- Tinnitus Loudness matching(from baseline to one and three months follow-up)
- Hospital Anxiety and Depression Scale (HADS)(from baseline to one and three months follow-up)
- Pure tone hearing thresholds(from baseline to one and three months follow-up)
- EuroQol (EQ-5D)(baseline, after last treatment session and at one and three months follow-up)
- Tinnitus pitch matching(from baseline to one and three months follow-up)
- Neck Bournemouth Questionnaire (NBQ) score(from baseline to one and three months follow-up)
研究者
Sarah Michiels
Prof. Dr.
Hasselt University