跳至主要内容
临床试验/NCT05734586
NCT05734586招募中不适用

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 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
1
主要终点
Proportion of complete achievement of steps 1 and 2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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,

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: 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.

干预措施: Protective measures for the upper airways (Procedure)

结局指标

主要结局

Proportion of complete achievement of steps 1 and 2

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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