Screening for Sarcopenic Dysphagia and the Implementation of Measures to Prevent Its Complications in Geriatric Patients [DYSPHAGING-PILOT] (DYSPHAGING-P)

Feasibility Study of Screening for Sarcopenic Dysphagia and the Implementation of Measures to Prevent Its Complications in Geriatric or Institutionalized Patients Aged ≥ 70 Years.

Sarcopenic dysphagia is described as a swallowing disorder caused by a loss of muscle mass and strength, sarcopenia. It induces chronic complications like micro-inhalations and the worsening of chronic undernutrition, according to a vicious circle. Awareness of the high prevalence of sarcopenic dysphagia and its serious consequences among elderly people with disabilities and hospitalized patients is recent, which explains the low rate of screening in the population concerned. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most exposed population are needed.

Two European learned societies have developed recommendations that include increased awareness of swallowing disorders, the use of screening scores, preventive measures, diagnostic standardization, and implemented interventions (rehabilitation, textural adaptation, etc.). In order to respect these recommendations, a pedagogical sheet, entitled DYSPHAGING was elaborated within our unit in a multiprofessional way in 4 steps (1 - Screen; 2 - Protect; 3 - Confirm; 4 - Rehabilitate).

This feasibility study aims to evaluate the rate of completion and the conditions for implementing steps 1 and 2 in hospital and institutional care units.

Study Overview

• Status: Recruiting
• Conditions: Swallowing Disorder; Sarcopanic Dysphagia
• Intervention / Treatment: Other: EAT-10 (Eating assessment Tool) screening questionnaire; Procedure: Protective measures for the upper airways

Detailed Description

Sarcopenic dysphagia is described as a swallowing disorder caused by a loss of muscle mass and strength, sarcopenia. It induces chronic complications like micro-inhalations and the worsening of chronic undernutrition, according to a vicious circle. Awareness of the high prevalence of sarcopenic dysphagia and its serious consequences among elderly people with disabilities and hospitalized patients is recent, which explains the low rate of screening in the population concerned. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most exposed population are needed.

Two European learned societies have developed recommendations that include increased awareness of swallowing disorders, the use of screening scores, preventive measures, diagnostic standardization, and implemented interventions (rehabilitation, textural adaptation, etc.). In order to respect these recommendations, a pedagogical sheet, entitled DYSPHAGING was elaborated within our unit in a multiprofessional way in 4 steps (1 - Screen; 2 - Protect; 3 - Confirm; 4 - Rehabilitate).

This feasibility study aims to evaluate the rate of completion and the conditions for implementing steps 1 and 2 in hospital and institutional care units.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion MERDINIAN, Dr; Phone Number: 00 33 4 78 86 56 83; Email: marion.merdinian@chu-lyon.fr
• Study Contact Backup: Name: Claire FALANDRY, Pr; Phone Number: 00 33 4 78 86 66 34; Email: claire.falandry@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69495
    • Recruiting
    • Centre Hospitalier Lyon Sud - Court Séjour Gériatrique
    • Contact: Marion MERDINIAN, Dr; Phone Number: 00 33 4 78 86 56 83; Email: marion.merdinian@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged ≥ 70 years,
• Patient affiliated to a social security system,
• Patient hospitalized in the health sector or in a medico-social institute,
• Patient informed of the study (information leaflet provided) and having orally signified their consent to inclusion in the study.
• Patient under legal protection, guardianship or curatorship,

Exclusion Criteria:

• Patient unable to feed orally,
• Patient with an active pathology responsible for acute swallowing disorders (< 3 months) (neurodegenerative pathology with predominant motor impairment such as Charcot's disease, stroke, ENT disease).
• Patient unable to answer the questionnaire.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: DYSPHAGING Interventional group; Step 1: delivery of the EAT-10 questionnaire for swallowing disorders screening;; Step 2: in case of EAT≥2 score, immediate implementation of upper airway protection measures in 3 areas:1: Postural adjustments; 2 : Hygienic and dietary rules ; 3: Food textures The hypothesis is that allied health professionals in acute geriatric wards, rehabilitation units, and Long Term Care Units are able to implement the current recommendations for screening for sarcopenic dysphagia and to implement preventive measures but in a systematic way. Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records. At the end of the study, each allied health professionals who has been involved in the care of at least one patient will fill out a satisfaction questionnaire.

Other: EAT-10 (Eating assessment Tool) screening questionnaire; After inclusion, issuance of the EAT-10 screening questionnaire for swallowing disorders by the healthcare team; Procedure: Protective measures for the upper airways; In the event of an EAT ≥2 score, immediate implementation or within three days by the healthcare team of protective measures for the upper airways in 3 sectors: 1: Postural maneuvers; 2: Hygienodietetic rules; 3: Food textures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of complete achievement of steps 1 and 2	The judgment criterion is validated if; Stage 1 is performed and the EAT-10 < 2 or if; Stage 1 is performed with an EAT-10 ≥ 2 and stage 2 is performed within 3 days after stage 1	Three days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eligible patients refusing to participate in the study	Number of eligible patients who refused to participate in the study	18 months
Age, gender, comorbidities (CIRS-G), autonomy (ADL, IADL), co-medications	Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.	19 months
Rate of partial completion of the protocol	Proportion of non-performance of step 1 and/or step 2 within the time limit. Proportion of steps 2 carried out incompletely), description of the reasons	19 months
Diagnosis of undernutrition and/or neurocognitive disorders and/or patent lung infection and/or COPD described in the patient's medical file, nutritional risk situation assessed by the Mini Nutritional Assessment® (MNA)	Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.	19 months
Composition and disciplines of the care team	At the end of the study, all data on the each allied health professionals will be collected on the dysphaging sheet	19 months
Caregiver satisfaction (Likert scale).	At the end of the study, each allied health professionals who has been involved in the care of at least one patient will fill out a satisfaction questionnaire.	19 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition; Prevention; Re-education
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 69HCL22_0474

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No