Development and Validation of the SWADOC Tool

Dysphagia Clinical Trial

Official title:

The Development and Validation of the SWADOC Tool: A Study Protocol for a Multicentric Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706689
• Other study ID #: 2020_79
• Status: Recruiting
• Start date: July 24, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: University of Liege
• Contact: Evelyne Mélotte, M.D.
• Phone: 00323663915
• Email: evelyne.melotte[@]chuliege.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Assessment Tool
• Communication Disorders
• Consciousness Disorders
• Deglutition Disorders
• Disorders of Consciousness
• Dysphagia
• Speech Therapy
• Swallowing Disorders

Intervention

Behavioral:
• SWADOC tool
The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients. It is composed of an average of 50 qualitative items and a subsection named "SWADOC-scored" comprising 8 quantitative items.
• FOTT-SAS
Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required

Locations

Country	Name	City	State
Belgium	Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz	Fraiture
Belgium	Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)	Jette
Belgium	Centre du Cerveau², University Hospital of Liège	Liège
Belgium	Cliniques de Soins Spécialisés Valdor-Pèrî	Liège
Belgium	Centre Hospitalier Neurologique William Lennox (UCL)	Ottignies-Louvain-la-Neuve	Brabant Wallon
France	Fontfroide functional re-education centre	Montpellier
France	CHU Nîmes	Nîmes
France	Uzès hospital	Uzès

Sponsors (9)

Lead Sponsor	Collaborator
University of Liege	Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB), Centre du Cerveau², Centre hospitalier universitaire de Liège, Centre Hospitalier Neurologique William Lennox (UCL), Centre Hospitalier Universitaire de Liege, Centre Hospitalier Universitaire de Nimes, Cliniques de Soins Spécialisés Valdor-Pèrî, Fontfroide functional re-education centre, Montpellier, France, Uzès hospital

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the SWADOC-scored during three sessions (Examiner 1) - Intra-reliability	The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection "SWADOC-scored" includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24).; The better the score is, the better the swallowing is.	15-25 minutes (3 times in 5 business days)
Primary	SECONDs	The Simplified Evaluation of CONsciousness Disorders (SECONDs): it features a shorter administration time (median of 7 minutes) and required only a mirror as material. It consists of 8 items: observation and reporting spontaneous behaviors, response to command, communication, visual pursuit and fixation, pain localization, oriented behaviors and arousal. The SECONDs provides a total score directly reflecting one diagnosis (0 = coma, 1 = UWS, 2-5 = MCS-, 6-7 = MCS+, 8 = EMCS). The better the score is, the better the consciousness level is.	7 minutes (immediately before or after the SWADOC tool in each of the three sessions)
Secondary	SWADOC-scored by Examiner 2 (inter-reliability)	The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection "SWADOC-scored" includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24). The better the score is, the better the swallowing is.	15-25 minutes - immediately before or after one of the three sessions
Secondary	FOTT-SAS (Examiner 1)	FOTT-SAS (Facial Oral Tract Therapy Swallowing Assessment of Saliva) The FOTT-SAS is a reliable assessment for detecting aspiration risk in patients with acquired brain injury.; The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated (the better the score is, the better the swallowing is, minimum of 0, maximum of 7).; The observations made during the assessment will permit to score the FOTT-SAS and verify the concurrent validity of the SWADOC tool.	Immediately after one of the three sessions