Validation of a Screening Tool for Swallowing Disorders for the Elderly (DéGluT'G)

January 10, 2024 updated by: University Hospital Center of Martinique

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Fort-de-France, France, 97261
        • Recruiting
        • University Hospital Center of Martinique
        • Contact:
        • Principal Investigator:
          • Seendy Bartholet, PhD
        • Sub-Investigator:
          • Bruno Perasie
        • Sub-Investigator:
          • Nerlande Ulysse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient aged 75 or over hospitalized in the Geriatric Short-Stay Unit
Two caregivers from the Geriatric Short-Stay Unit will successively administer the "Deglut'G" tool to each patient, blind to each other, and blind to the SLP and ENT doctor examination. All patients will have a SLP examination and an ENT doctor examination aimed at detecting swallowing disorders.

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.

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the concordance between the results of the SLP examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders.
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 12 months

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
Measure the concordance of the measurements obtained with the Deglut'G tool between two caregivers, for the detection of swallowing disorders
Time Frame: 12 months
Inter-rater reliability of Deglut'G screening
12 months
Estimate the average time it takes to use the Deglut'G tool
Time Frame: 12 months
Time taken to take the Déglut'G tests (in minutes)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Seendy Bartholet, PhD, University Hospital Center of Martinique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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