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

Primary Purpose

Swallowing Disorder, Sarcopanic Dysphagia

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EAT-10 (Eating assessment Tool) screening questionnaire
Protective measures for the upper airways
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Swallowing Disorder focused on measuring Prevention, Nutrition, Re-education

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Lyon Sud - Court Séjour Gériatrique

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DYSPHAGING Interventional group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of eligible patients refusing to participate in the study
Number of eligible patients who refused to participate in the study
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.
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
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.
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
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.

Full Information

First Posted
January 27, 2023
Last Updated
February 8, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05734586
Brief Title
Screening for Sarcopenic Dysphagia and the Implementation of Measures to Prevent Its Complications in Geriatric Patients [DYSPHAGING-PILOT]
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorder, Sarcopanic Dysphagia
Keywords
Prevention, Nutrition, Re-education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DYSPHAGING Interventional group
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
EAT-10 (Eating assessment Tool) screening questionnaire
Intervention Description
After inclusion, issuance of the EAT-10 screening questionnaire for swallowing disorders by the healthcare team
Intervention Type
Procedure
Intervention Name(s)
Protective measures for the upper airways
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of complete achievement of steps 1 and 2
Description
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
Time Frame
Three days
Secondary Outcome Measure Information:
Title
Percentage of eligible patients refusing to participate in the study
Description
Number of eligible patients who refused to participate in the study
Time Frame
18 months
Title
Age, gender, comorbidities (CIRS-G), autonomy (ADL, IADL), co-medications
Description
Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.
Time Frame
19 months
Title
Rate of partial completion of the protocol
Description
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
Time Frame
19 months
Title
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)
Description
Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.
Time Frame
19 months
Title
Composition and disciplines of the care team
Description
At the end of the study, all data on the each allied health professionals will be collected on the dysphaging sheet
Time Frame
19 months
Title
Caregiver satisfaction (Likert scale).
Description
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.
Time Frame
19 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion MERDINIAN, Dr
Phone
00 33 4 78 86 56 83
Email
marion.merdinian@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire FALANDRY, Pr
Phone
00 33 4 78 86 66 34
Email
claire.falandry@chu-lyon.fr
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud - Court Séjour Gériatrique
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion MERDINIAN, Dr
Phone
00 33 4 78 86 56 83
Email
marion.merdinian@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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