Evidence map›Paper›PMID 35606823›Full record

ArticleTrials2022

Cost-effectiveness of a smartphone Application for Tinnitus Treatment (the CATT trial): a study protocol of a randomised controlled trial.

Sara Demoen, Laure Jacquemin, Annick Timmermans, Vincent Van Rompaey, Olivier Vanderveken, Hanne Vermeersch, Iris Joossen, Julie Van Eetvelde, Winfried Schlee, Wim Marneffe and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05245318 (Cost-effectiveness of a Smartphone Application for Tinnitus Treatment), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05245318 naunknown statusnot on this map

Cost-effectiveness of a Smartphone Application for Tinnitus Treatment (The CATT Trial): A Study Protocol of a Randomised Controlled Trial

TypeinterventionalSponsorHasselt UniversityRan2022 to 2025Enrolled334ConditionsTinnitusArmsStandard Clinical care, Blended physiotherapy program
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Sara DemoenRehabilitation Research Center, REVAL, faculty of Rehabilitation Sciences, Hasselt University, 3500, Hasselt, Belgium. sara.demoen@uhasselt.be.ORCID http://orcid.org/0000-0003-0317-5079
Laure JacqueminDepartment of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital, 2650, Edegem, Belgium.
Annick TimmermansRehabilitation Research Center, REVAL, faculty of Rehabilitation Sciences, Hasselt University, 3500, Hasselt, Belgium.
Vincent Van RompaeyDepartment of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital, 2650, Edegem, Belgium.
Olivier VandervekenDepartment of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital, 2650, Edegem, Belgium.
Hanne VermeerschDepartment of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital, 2650, Edegem, Belgium.
Iris JoossenDepartment of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital, 2650, Edegem, Belgium.
Julie Van EetveldeRehabilitation Research Center, REVAL, faculty of Rehabilitation Sciences, Hasselt University, 3500, Hasselt, Belgium.
Winfried SchleeDepartment of Psychiatry and Psychotherapy, University of Regensburg, 93053, Regensburg, Germany.
Wim MarneffeFaculty of Business Economics, Hasselt University, 3500, Hasselt, Belgium.
Janis LuytenFaculty of Business Economics, Hasselt University, 3500, Hasselt, Belgium.
Annick Gilles *Department of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital, 2650, Edegem, Belgium.
Sarah Michiels *Rehabilitation Research Center, REVAL, faculty of Rehabilitation Sciences, Hasselt University, 3500, Hasselt, Belgium.

Funding

FWO Vlaanderen T02221N
6 · The paper itself

Abstract

backgroundTinnitus is a highly prevalent symptom, affecting 10-15% of the adult population. Tinnitus influenced by alterations in somatosensory afference from the neck or jaw is referred to as somatic tinnitus (ST). ST is known to respond positively to physiotherapy treatment; however, it is challenging to motivate patients to systematically perform home exercises correctly, and the necessary tinnitus counselling is often lacking. The aim of this study is twofold, namely to investigate both the effectiveness and cost-effectiveness of a blended physiotherapy program for ST, including a smartphone application designed to increase exercise therapy compliance and provide tinnitus counselling.

methodsThis study is designed as a single-blind two-arm 1:1 randomised controlled trial (RCT). Adult patients diagnosed with ST, without psychiatric comorbidities and with experience in using a smartphone, will be recruited at the Ear Nose Throat (ENT) department of the Antwerp University Hospital (UZA). Patients will be randomised into two groups. The experimental group will receive the blended physiotherapy program comprising six in-clinic physiotherapy sessions over a period of 12 weeks (1x/2 weeks) and an exercise and counselling program provided by the smartphone application. The control group will receive the standard care program comprising twelve weekly in-clinic physiotherapy sessions. Each physiotherapy session has a duration of 30 min. The primary outcome measure is the change in Tinnitus Functional Index (TFI) score. Additionally, a cost-effectiveness analysis will be performed from a societal perspective considering both direct and indirect costs. There will be follow-up assessments at one and 3 months after the final treatment session. DISCUSSION: Our study is the first to combine both tinnitus counselling and neck/jaw treatment provided by a digital application in a blended physiotherapy program. This, in order to empower ST patients to improve and better manage their own health and, possibly, reduce economic costs by alleviating the tinnitus burden that ST patients experience. The strengths of the planned RCT are the high-quality methodological design, the large sample size and the expertise of the involved multidisciplinary research team.

trial registrationClinicaltrials.gov NCT05245318 . Registered on 26 January 2022.

Indexed as

Mobile ApplicationsTinnitusAdultCost-Benefit AnalysisHumansPhysical Therapy ModalitiesRandomized Controlled Trials as TopicSmartphoneTreatment OutcomeBlended physiotherapyRandomised controlled trialSmartphone applicationSomatic tinnitusTelerehabilitation

Identifiers

PMID35606823
PMCPMC9125968

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.