Validation of a Screening Tool for Swallowing Disorders for the Elderly

Dysphagia Clinical Trial

— DéGluT'G  

Official title:

Validation of a Screening Tool for Swallowing Disorders for the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163118
• Other study ID #: 21_RIPH2-14
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: November 2023
• Source: University Hospital Center of Martinique
• Contact: Seendy Bartholet, PhD
• Phone: 05 96 55 11 76
• Email: seendy.bartholet[@]chu-martinique.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Swallowing disorder, or dysphagia, is a lack of protection of the airways during the passage of the food bolus towards the esophagus. Swallowing disorder is characterized by a feeling of discomfort when swallowing, difficult swallowing in elderly people or a blockage felt during the progression of food between the mouth and the stomach, sometimes with falsities. These disorders can be the cause of a loss of appetite and a reduction in food consumption in older people. In the most serious cases, they can lead to aspiration, weakening the pulmonary passages and possibly leading to suffocation. Swallowing disorders constitute an important public health problem due to their prevalence among the elderly. Many early readmissions could be avoided thanks to better quality of care in these patients. In the elderly, the number of comorbidities and the multiplicity of medications and drug intake increase the incidence of swallowing disorders in this population. They constitute a common pathology, probably underestimated and underdiagnosed in the geriatric population. Given the aging of the Martinique population, it is appropriate to offer an easy-to-use, quickly achievable tool for diagnostic purposes, making it possible to quickly identify potential swallowing disorders, and therefore to anticipate meal intake, and on the adaptation of the prescription to a medicinal alternative (before any food or medication taken during hospitalization). In the Geriatric Short-Stay Unit of the Martinique University Hospital, a tool called "Deglut'G", was developed, and has been used since 2015, in order to allow caregivers a rapid, reliable and relevant assessment of swallowing disorders in the elderly, in order to guide care and medication alternatives.It now appears important to validate this tool, by comparing it with the results of examinations of swallowing disorders obtained from a speech-language pathologists (SLPs) and an ENT doctor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Person aged 75 or over hospitalized in the Geriatric Short-Stay Unit,
• Person having been informed of the research,
• Person having given free written and informed consent,
• Person affiliated to a social security scheme.

Exclusion Criteria:

• Person unable to take the tests,
• Person with an oral condition that hinders normal swallowing (stomatitis, gingivitis, etc.),
• Elderly person under legal protection, under guardianship or curatorship,
• Person who refused to participate in the study.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Swallowing Disorder

Intervention

Diagnostic Test:
• Deglut'G test
Two tests to assess swallowing disorders using the Deglut'G tool will be carried out by a nurse or a caregiver from the Geriatric Short-Stay Unit, at visit 1. The tests can be taken successively, or spaced apart by a time defined by the medical team, and will be taken blind to each other. The average test administration time will be measured during the study, but the test should not exceed 10 minutes depending on the patients. The Deglut'G tool consists of an initial administration of gelled water (1 to 3 teaspoons), to identify if a cough occurs. In the event of a cough, the oral treatment is stopped; if the cough is absent, a new step this time consists of the administration of water (1 to 3 sips). In case of cough, the food will be mixed, the liquids thickened, and the medicinal treatments crushed. If there is no cough, foods and liquids can be taken as normal.
• SLP swallowing test
At visit 1, 1 to 2 hours after the last Deglut'G test, a second swallowing test will be carried out by a SLP according to his skills and according to his usual practice, independently of the Deglut'G tool. This test should not exceed 20-30 minutes depending on the patient.
• ENT doctor swallowing test
At Visit 2 (day 7 +/- 3 days after the inclusion), still as part of the short-stay hospitalization, the patient will meet an ENT doctor who will carry out an examination aimed at detecting swallowing disorders, according to his usual practice, of independent of the Deglut'G tool. The examination should not exceed 20-30 minutes depending on the patient.

Locations

Country	Name	City	State
France	University Hospital Center of Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the concordance between the results of the SLP examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders.	Concordance between the results of the Deglut'G test and the SLP assessment.; The evaluation of a swallowing disorder via the DegluT'G tool, by the geriatric short-stay unit caregivers, will be done as follows: Presence of cough following administration of gelled water : suspicion of swallowing disorder; Presence of cough following administration of water : suspicion of swallowing disorder; Absence of cough following administration of water : no swallowing disorder; This assessment will be compared to the SLP assessment, whatever the assessment method used.	12 months
Secondary	Measure the concordance between the results of the ENT doctor examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders	Concordance between the results of the Deglut'G test and the ENT doctor assessment.; The evaluation of a swallowing disorder via the DegluT'G tool, by the geriatric short-stay unit caregivers, will be done as follows: Presence of cough following administration of gelled water : suspicion of swallowing disorder; Presence of cough following administration of water : suspicion of swallowing disorder; Absence of cough following administration of water : no swallowing disorder; This assessment will be compared to the ENT doctor assessment, whatever the assessment method used.	12 months
Secondary	Measure the concordance of the measurements obtained with the Deglut'G tool between two caregivers, for the detection of swallowing disorders	Inter-rater reliability of Deglut'G screening	12 months
Secondary	Estimate the average time it takes to use the Deglut'G tool	Time taken to take the Déglut'G tests (in minutes)	12 months