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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05734586
Collaborator
(none)
102
1
1
19.1
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: EAT-10 (Eating assessment Tool) screening questionnaire
  • Procedure: Protective measures for the upper airways
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility Study of Screening for Sarcopenic Dysphagia and the Implementation of Measures to Prevent Its Complications in Geriatric or Institutionalized Patients Aged ≥ 70 Years.
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of complete achievement of steps 1 and 2 [Three days]

    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

Secondary Outcome Measures

  1. Percentage of eligible patients refusing to participate in the study [18 months]

    Number of eligible patients who refused to participate in the study

  2. Age, gender, comorbidities (CIRS-G), autonomy (ADL, IADL), co-medications [19 months]

    Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.

  3. Rate of partial completion of the protocol [19 months]

    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

  4. 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]

    Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.

  5. Composition and disciplines of the care team [19 months]

    At the end of the study, all data on the each allied health professionals will be collected on the dysphaging sheet

  6. Caregiver satisfaction (Likert scale). [19 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Exclusion Criteria:
  • Patient unable to feed orally,

  • Patient under legal protection, guardianship or curatorship,

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Lyon Sud - Court Séjour Gériatrique Lyon France 69495

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05734586
Other Study ID Numbers:
  • 69HCL22_0474
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023