An observational study in Swallowing Disorders, Dysphagia and Disorders of Consciousness, sponsored by University of Liege. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by University of Liege · Observational
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 104 is above the median of 84 across 249 observational studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →University of Liege is the lead sponsor of 251 studies on the registry; 50 are open to participants now.
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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 :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: FOTT-SAS
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 · Behavioral: FOTT-SAS
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 · Behavioral: FOTT-SAS
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 · Behavioral: FOTT-SAS
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.
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
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.
Time frame: 15-25 minutes (3 times in 5 business days)
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.
Time frame: 7 minutes (immediately before or after the SWADOC tool in each of the three sessions)
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.
Time frame: 15-25 minutes - immediately before or after one of the three sessions
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.
Time frame: Immediately after one of the three sessions
Plan to share: Undecided
Started Jul 2020 (actual). Primary completion is estimated for Dec 2024, 53 months after the start.
Of 117 non-industry observational studies under Deglutition Disorders, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 52. This study's planned 53 months is above that.
Counting every sponsor, half of 120 studies reached it within 25 months; a quarter within 11 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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