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Clinical Trials/NCT05734586
NCT05734586RecruitingNot Applicable

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

Hospices Civils de Lyon1 site in 1 country102 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
102
Locations
1
Primary Endpoint
Proportion of complete achievement of steps 1 and 2

Study Overview

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.

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
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
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.
  • •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.

Arms & Interventions

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.

Intervention: EAT-10 (Eating assessment Tool) screening questionnaire (Other)

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.

Intervention: Protective measures for the upper airways (Procedure)

Outcomes

Primary Outcomes

Proportion of complete achievement of steps 1 and 2

Time Frame: Three days

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

Secondary Outcomes

  • Percentage of eligible patients refusing to participate in the study(18 months)
  • Composition and disciplines of the care team(19 months)
  • Rate of partial completion of the protocol(19 months)
  • Age, gender, comorbidities (CIRS-G), autonomy (ADL, IADL), co-medications(19 months)
  • Caregiver satisfaction (Likert scale).(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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