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

Swallowing Disorder Clinical Trial

— DYSPHAGING-P  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734586
• Other study ID #: 69HCL22_0474
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Marion MERDINIAN, Dr
• Phone: 00 33 4 78 86 56 83
• Email: marion.merdinian[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Disorder

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud - Court Séjour Gériatrique	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of eligible patients refusing to participate in the study	Number of eligible patients who refused to participate in the study	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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