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临床试验/NCT05389098
NCT05389098招募中不适用

L'Alimentation Manger-mains, le Plaisir au Bout Des Doigts : Etude Pilote randomisée, en Ouvert et en Groupes parallèles

University Hospital, Tours4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
4
主要终点
Audit & Questionnaire of feasibility

研究概览

简要总结

Food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. This new way of eating can help limit weight loss, increase food intake, gain independence and improve the enjoyment of eating for residents.

详细描述

According to the Haute Autorité de Santé (HAS), undernutrition affects between 15 and 38% of elderly people living in institutions and between 50 and 60% of hospitalized elderly people. In addition, a significant decrease in satisfaction with meals was observed with increasing level of dependence.

The objective of the study is to evaluate the feasibility of implementing the finger food in care settings that could have a positive impact on the nutritional status of elderly people living in EHPAD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
75 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female residents over 75 years old living in a Accommodation facility for dependent elderly people for at least 3 months
  • Presenting at least one of the following 3 criteria:
  • Unintentional weight loss ≥ 5% in 1 month
  • Involuntary weight loss ≥ 10% in 6 months or compared to the usual weight or compared to the weight at entry to the EHPAD
  • Confirmed sarcopenia:
  • Male (at least one of the 2 criteria):
  • Dynamometer (kg): < 27 AND calf circumference (cm): < 31
  • Impedancemetry: appendicular muscle mass index < 20 kg OR appendicular muscle mass index < 7 kg/m²
  • Woman (at least one of the 2 criteria):
  • Dynamometer (kg): < 16 AND calf circumference (cm): < 31
  • Impedancemetry: appendicular muscle mass index < 15 kg OR appendicular muscle mass index < 5.5 kg/m²
  • Loss of autonomy according to the Tully scale < 12/18 with a score of 2 or 3 on the item "Able to bite, chew, swallow without making false routes"
  • Person having given free, informed and express consent
  • Person having an affiliation to a social security scheme

排除标准

  • Protected person: safeguard of justice
  • Swallowing disorder having a contra-indication to the texture of hand-eating meals.
  • Lack of motor skills in both hands
  • Specific diet: pleasure diet, salt-free, sugar-free, fiber-free, artificial nutrition
  • Wearer of a pacemaker

结局指标

主要结局

Audit & Questionnaire of feasibility

时间窗: After 3 patients included and at the end of study (6 months)

Feasibility of implementing finger food for elderly patients in care settings will be evaluate with audit and questionnaire for caregivers by a dietician independent of the study.

次要结局

  • Weight(Every two weeks during 6 months)
  • Eating pleasure(Every month during 6 months)
  • Food consumption(Each week during 6 months)
  • False routes(Every week during 6 months)
  • Autonomy (EBS)(Every month during 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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