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临床试验/NCT05299541
NCT05299541终止不适用

Nutritional Support in Patients Who Have Been Diagnosed at Nutritional Risk in the Hospital and Discharged Home. How we Can Improved the Prognosis and Quality of Life.

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
1
主要终点
changed financials costs per patient in health system

研究概览

简要总结

Background: Many malnourished hospital patients remain after discharge. We aimed to enhance the meal experience after discharge by delivering meals together with physical support at the home and tested if this increased food intake affected survival and quality of life.

Patients and Methods: 60 discharged patients suffering from nutritional (MUST>2) and financial frailty were included. Control group (C) took their regular nutrition at home for 6 months and study group (S) received a daily dinner tray sponsored by the municipality. Hazalla philanthropic organization encouraged the patients at lunch for 6 months. Body composition (Quadstat 4000, Bodystat, UK), energy requirements (Fitmate- COSMED, Italy) were measured at recruitement. Primary outcome was 180 days survival. In addition, in the recruitment stage and after a period of 3 and 6 months, depression and anxiety questionnaire (HADS), quality of Life Questionnaire-SF36and FIM questionnaire - designed to examine the level of independence of patients with disability were performed at days 0, 90 and 180. Statistical analysis used T- Test and ANOVA Repeated Measures. The study was approved by local IRB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • MUST =>2
  • Region of living Bney-Brak or Petah-tikwa
  • Fine cognitive state

排除标准

  • Progressive cancer
  • Fiddling by PEG or Enteral nutrient via Naso gastric tube
  • Psychiatrics disorder

结局指标

主要结局

changed financials costs per patient in health system

时间窗: 6 months

follow up through electronic medical records

changed Mortality

时间窗: 6 months

six mounth follow up through ATD (American Trans Data Corp)

Improve quality of life

时间窗: 6 months

HADS questionnaire (hospital anxiety ans depression scale), scale 0-21. 0-7: normal; 8-10: borderline; 11-21: abnormal.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre Singer

ICU Manager

Rabin Medical Center

研究点 (1)

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