Clinical trial NCT04706689: Development and Validation of the SWADOC Tool
Official title: The Development and Validation of the SWADOC Tool: A Study Protocol for a Multicentric Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Swallowing Disorders
Dysphagia
Disorders of Consciousness
Assessment Tool
Speech Therapy
Keywords: swallowing
dysphagia
disorders of consciousness
severe brain injury
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Centre du Cerveau², Centre hospitalier universitaire de Liège
name: Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)
name: Cliniques de Soins Spécialisés Valdor-Pèrî
name: Centre Hospitalier Neurologique William Lennox (UCL)
name: Centre Hospitalier Universitaire de Liege
name: Centre Hospitalier Universitaire de Nīmes
name: Uzès hospital
name: Fontfroide functional re-education centre, Montpellier, France
First posted: 2021-01-13
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be carried out in patients with DOC or emerging from DOC following severe acquired brain injury. Patients will be divided into four groups according to their clinical diagnosis assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs): UWS, MCS-, MCS+ and EMCS. Participants will be recruited from inpatient neurological rehabilitation programs in post-coma units and rehabilitation services, or hospitalized for an evaluation of multimodal assessment of consciousness for diagnostic and prognostic purposes.

We will include 26 patients in each group, which will result in a total of 104 patients.

Brief summary: Background: After a period of coma, patients with severe brain injury may present disorders of consciousness (DOC). A wide proportion of these patients also suffer from severe dysphagia. Assessment and therapy of swallowing disabilities of DOC patients are essential because dysphagia has major functional consequences and comorbidities. Dysphagia evaluation in patients with DOC is hampered by the lack of adapted tools. The first aim of the study was to develop a new tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), and propose a validation protocol. The SWADOC tool has been developed to help therapists to apprehend components related to swallowing in patients with DOC. The second aim is to appreciate the relationship between patients' level of consciousness and SWADOC items and scores.

Method/design: In this multicentric prospective cohort, 104 patients with DOC will be tested three times during two consecutive days with the SWADOC tool. Statistical analyses will focus on the reliability and validity of the SWADOC tool, especially the intra and inter-rater reliability, internal consistency, measures of dispersion and concurrent validity with the FOTT Swallowing Assessment of Saliva (FOTT-SAS). The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R)

Discussion: The assessment of swallowing abilities among patients with DOC is the first necessary step towards the development of an individualized dysphagia care plan. A validated scoring tool will be essential for clinicians to better apprehend dysphagia in DOC patients and to document the evolution of their disorders.


Eligibility criteria: Inclusion Criteria :

* Age above 18-year-old
* Perfect knowledge of French language before the injury
* Previous event of coma phase caused by a severe acquired brain injury
* Medical stability (absence of mechanical ventilation and sedation, no acute medical pathology such as infection or respiratory distress)
* No neurological or otorhinolaryngological disease which can impact swallowing prior to the brain injury
* Minimum of 28 days since the acquired brain injury at inclusion
* Diagnosis of UWS, MCS-, MCS+ or EMCS based on the CRS-R or SECONDs
* Informed consent from legal representative of the patient
* Affiliated patient or beneficiary of a health insurance plan (for French participants only).

Primary outcomes:
measure: Change in the SWADOC-scored during three sessions (Examiner 1) - Intra-reliability
timeFrame: 15-25 minutes (3 times in 5 business days)
measure: SECONDs
timeFrame: 7 minutes (immediately before or after the SWADOC tool in each of the three sessions)
Secondary outcomes:
measure: SWADOC-scored by Examiner 2 (inter-reliability)
timeFrame: 15-25 minutes - immediately before or after one of the three sessions
measure: FOTT-SAS (Examiner 1)
timeFrame: Immediately after one of the three sessions
Other outcomes:
Locations:
city: Ottignies-Louvain-la-Neuve
country: Belgium
facility: Centre Hospitalier Neurologique William Lennox (UCL)
state: Brabant Wallon
city: Fraiture
country: Belgium
facility: Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz
city: Jette
country: Belgium
facility: Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)
city: Liège
country: Belgium
facility: Centre du Cerveau², University Hospital of Liège
city: Liège
country: Belgium
facility: Cliniques de Soins Spécialisés Valdor-Pèrî
city: Montpellier
country: France
facility: Fontfroide functional re-education centre
city: Nîmes
country: France
facility: CHU Nîmes
city: Uzès
country: France
facility: Uzès hospital
Study officials:
affiliation: University of Liege, Giga Consciousness
name: Olivia Gosseries, PhD
role: STUDY_DIRECTOR
References:
citation: Melotte E, Maudoux A, Delhalle S, Lagier A, Thibaut A, Aubinet C, Kaux JF, Vanhaudenhuyse A, Ledoux D, Laureys S, Gosseries O. Swallowing in individuals with disorders of consciousness: A cohort study. Ann Phys Rehabil Med. 2021 Jul;64(4):101403. doi: 10.1016/j.rehab.2020.04.008. Epub 2020 Jul 18.
citation: Sanz LRD, Aubinet C, Cassol H, Bodart O, Wannez S, Bonin EAC, Barra A, Lejeune N, Martial C, Chatelle C, Ledoux D, Laureys S, Thibaut A, Gosseries O. SECONDs Administration Guidelines: A Fast Tool to Assess Consciousness in Brain-injured Patients. J Vis Exp. 2021 Feb 6;(168). doi: 10.3791/61968.
citation: Mortensen J, Jensen D, Kjaersgaard A. A validation study of the Facial-Oral Tract Therapy Swallowing Assessment of Saliva. Clin Rehabil. 2016 Apr;30(4):410-5. doi: 10.1177/0269215515584381. Epub 2015 Apr 28.
citation: Bicego A, Lejoly K, Maudoux A, Lefebvre P, Laureys S, Schweizer V, Diserens K, Faymonville ME, Vanhaudenhuyse A. [Swallowing in disorders of consciousness]. Rev Neurol (Paris). 2014 Oct;170(10):630-41. doi: 10.1016/j.neurol.2014.04.004. Epub 2014 Jun 18. French.
citation: Wannez S, Gosseries O, Azzolini D, Martial C, Cassol H, Aubinet C, Annen J, Martens G, Bodart O, Heine L, Charland-Verville V, Thibaut A, Chatelle C, Vanhaudenhuyse A, Demertzi A, Schnakers C, Donneau AF, Laureys S. Prevalence of coma-recovery scale-revised signs of consciousness in patients in minimally conscious state. Neuropsychol Rehabil. 2018 Dec;28(8):1350-1359. doi: 10.1080/09602011.2017.1310656. Epub 2017 Apr 11.
citation: Melotte E, Belorgeot M, Herr R, Simon J, Kaux JF, Laureys S, Sanz LRD, Lagier A, Morsomme D, Pellas F, Gosseries O. The Development and Validation of the SWADOC: A Study Protocol for a Multicenter Prospective Cohort Study. Front Neurol. 2021 Apr 29;12:662634. doi: 10.3389/fneur.2021.662634. eCollection 2021.