Development and Validation of the SWADOC Tool

University of Liege

Status: Enrolling

Conditions: Dysphagia; Swallowing Disorders; Speech Therapy; Disorders of Consciousness; Assessment Tool

Treatments: Behavioral: SWADOC tool; Behavioral: FOTT-SAS

Study type: Observational

Funder types: Other

Identifiers

NCT04706689

2020_79

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

104 participants in 4 patient groups

Unresponsive wakefulness syndrome patients (UWS)

Description:

The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).

Treatment:

Behavioral: FOTT-SAS

Behavioral: SWADOC tool

Minimally conscious patients MINUS (MCS-)

Description:

The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).

Treatment:

Behavioral: FOTT-SAS

Behavioral: SWADOC tool

Minimally conscious patients PLUS

Description:

The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).

Treatment:

Behavioral: FOTT-SAS

Behavioral: SWADOC tool

Patients emerging from the minimally conscious state (EMCS)

Description:

The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).

Treatment:

Behavioral: FOTT-SAS

Behavioral: SWADOC tool