Development and Validation of the SWADOC Tool
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| ClinicalTrials.gov Identifier: NCT04706689 |
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Recruitment Status :
Recruiting
First Posted : January 13, 2021
Last Update Posted : September 29, 2021
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Swallowing Disorders Dysphagia Disorders of Consciousness Assessment Tool Speech Therapy | Behavioral: SWADOC tool Behavioral: FOTT-SAS |
| Study Type : | Observational |
| Estimated Enrollment : | 104 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Development and Validation of the SWADOC Tool: A Study Protocol for a Multicentric Prospective Cohort Study |
| Actual Study Start Date : | July 24, 2020 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | June 30, 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Unresponsive wakefulness syndrome patients (UWS)
The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
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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. Behavioral: 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 |
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Minimally conscious patients MINUS (MCS-)
The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
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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. Behavioral: 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 |
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Minimally conscious patients PLUS
The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
|
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. Behavioral: 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 |
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Patients emerging from the minimally conscious state (EMCS)
The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
|
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. Behavioral: 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 |
- Change in the SWADOC-scored during three sessions (Examiner 1) - Intra-reliability [ Time Frame: 15-25 minutes (3 times in 5 business days) ]
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.
- SECONDs [ Time Frame: 7 minutes (immediately before or after the SWADOC tool in each of the three sessions) ]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.
- SWADOC-scored by Examiner 2 (inter-reliability) [ Time Frame: 15-25 minutes - immediately before or after one of the three sessions ]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.
- FOTT-SAS (Examiner 1) [ Time Frame: Immediately after one of the three sessions ]
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706689
| Contact: Evelyne Mélotte, M.D. | 00323663915 | evelyne.melotte@chuliege.be | |
| Contact: Marion Belorgeot, M.D. | marion.belorgeot@wanadoo.fr |
| Belgium | |
| Centre Hospitalier Neurologique William Lennox (UCL) | Recruiting |
| Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium, 1340 | |
| Contact: Nicolas Lejeune, M.D., Ph.D. nicolas.lejeune@chnwl.be | |
| Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz | Recruiting |
| Fraiture, Belgium, 4557 | |
| Contact: Jenny Paluszkiewicz jpaluszkiewicz@chuliege.be | |
| Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB) | Recruiting |
| Jette, Belgium | |
| Contact: Valérie Chavet, M.D. Valerie.Chavet@erasme.ulb.ac.be | |
| Contact: Elodie Guichard, M.D. Elodie.Guichard@erasme.ulb.ac.be | |
| Centre du Cerveau², University Hospital of Liège | Recruiting |
| Liège, Belgium, 4000 | |
| Contact: Evelyne Mélotte, M.D. +323667248 evelyne.melotte@chuliege.be | |
| Contact: Olivia Gosseries, Ph.D. +3243663954 ogosseries@uliege.be | |
| Cliniques de Soins Spécialisés Valdor-Pèrî | Recruiting |
| Liège, Belgium, 4000 | |
| Contact: Haroun Jedidi, M.D. haroun.jedidi@alumni.uliege.be | |
| France | |
| Fontfroide functional re-education centre | Recruiting |
| Montpellier, France | |
| Contact: Jean-Baptiste Chevallier +33 4 67 61 79 79 jeanbaptiste.chevallier@wanadoo.fr | |
| CHU Nîmes | Not yet recruiting |
| Nîmes, France | |
| Contact: Frederic Pellas +33 4 66 68 38 56 frederic.pellas@chu-nimes.fr | |
| Uzès hospital | Not yet recruiting |
| Uzès, France | |
| Contact: Valérie Dimanchin +33 4 66 63 71 00 valerie.dimanchin@chuzes.fr | |
| Study Director: | Olivia Gosseries, PhD | University of Liege, Giga Consciousness |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Olivia Gosseries, Neuropsychologist, PhD, Co-director of the Coma Science Group, Research Associate at FRS-FNRS, University of Liege |
| ClinicalTrials.gov Identifier: | NCT04706689 |
| Other Study ID Numbers: |
2020_79 |
| First Posted: | January 13, 2021 Key Record Dates |
| Last Update Posted: | September 29, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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swallowing dysphagia disorders of consciousness severe brain injury |
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Deglutition Disorders Consciousness Disorders Communication Disorders Disease Pathologic Processes Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Pharyngeal Diseases Otorhinolaryngologic Diseases Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurocognitive Disorders Mental Disorders Neurodevelopmental Disorders |