NCT05734586

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

January 27, 2023

Last Update Submit

January 24, 2024

Conditions

Swallowing DisorderSarcopanic Dysphagia

Keywords

PreventionNutritionRe-education

Outcome Measures

Primary Outcomes (1)

  • Proportion of complete achievement of steps 1 and 2

    The judgment criterion is validated if 1. Stage 1 is performed and the EAT-10 \< 2 or if 2. Stage 1 is performed with an EAT-10 ≥ 2 and stage 2 is performed within 3 days after stage 1

    Three days

Secondary Outcomes (6)

  • Percentage of eligible patients refusing to participate in the study

    18 months

  • Age, gender, comorbidities (CIRS-G), autonomy (ADL, IADL), co-medications

    19 months

  • Rate of partial completion of the protocol

    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)

    19 months

  • Composition and disciplines of the care team

    19 months

  • +1 more secondary outcomes

Study Arms (1)

DYSPHAGING Interventional group

OTHER

* 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 questionnaireProcedure: Protective measures for the upper airways

Interventions

EAT-10 (Eating assessment Tool) screening questionnaireOTHER

After inclusion, issuance of the EAT-10 screening questionnaire for swallowing disorders by the healthcare team

DYSPHAGING Interventional group
Protective measures for the upper airwaysPROCEDURE

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

DYSPHAGING Interventional group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient aged ≥ 70 years,
  • Patient affiliated to a social security system,
  • Patient hospitalized in the health sector or in a medico-social institute,
  • Patient under legal protection, guardianship or curatorship,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud - Court Séjour Gériatrique

Lyon, 69495, France

RECRUITING

Related Publications (1)

  • Durlach O, Tripoz-Dit-Masson S, Masse-Deragon N, Subtil F, Niasse-Sy Z, Herledan C, Guittard L, Goldet K, Merazga S, Chabert M, Suel A, Dayde D, Merdinian M, Falandry C. Feasibility of a screening and prevention procedure for risks associated with dysphagia in older patients in geriatric units: the DYSPHAGING pilot study protocol. BMJ Open. 2024 Apr 19;14(4):e081333. doi: 10.1136/bmjopen-2023-081333.

    PMID: 38642998DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Marion MERDINIAN, Dr

CONTACT

00 33 4 78 86 56 83marion.merdinian@chu-lyon.fr

Claire FALANDRY, Pr

CONTACT

00 33 4 78 86 66 34claire.falandry@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 21, 2023

Study Start

June 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations

FR(1)