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临床试验/NCT04042987
NCT04042987已完成不适用

Assessing Malnutrition Prevalence and Impact of a Nutrition-Focused Quality Improvement Program (QIP) Among Community-Dwelling Malnourished Colombian Patients Receiving Care in an Ambulatory Health Clinic

Abbott Nutrition1 个研究点 分布在 1 个国家目标入组 1,325 人开始时间: 2019年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,325
试验地点
1
主要终点
Prevalence of Malnutrition

研究概览

简要总结

This study aims to assess the malnutrition prevalence of Colombian community-dwelling adults and evaluate the feasibility of a nutrition-focused QIP implemented in a Colombian ambulatory care facility on healthcare utilization.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • Patient is screened as being malnourished or at risk for malnutrition
  • Patient can consumer beverages and food orally
  • Patients have a life expectancy of equal or greater than 90 days
  • Patient is literate and willing to voluntarily sign and date an Informed Consent Form (ICF) after it is explained

排除标准

  • Patient is pregnant
  • Patient is intubated, receiving tube feeding or parenteral nutrition
  • Patient has severe dementia, delirium or history of significant psychiatric disorder and no dedicated caregiver who could assure their compliance with QIP study requirements and help with the completion of QIP study materials
  • Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures
  • Patient has an allergy or intolerance to any of the ONS ingredients
  • Patients does not want to participate or sign ICF
  • Patient is bedridden or confined in a wheelchair

结局指标

主要结局

Prevalence of Malnutrition

时间窗: Change from Baseline to Week 10 post-QIP enrollment

Measured by the Mini Nutritional Assessment (MNA®) a maximum 30 point scale resulting in a single Malnutrition Indicator Score where lower number indicates malnutrition

次要结局

  • Healthcare Resource Utilization(10-weeks follow-up period post enrollment from ambulatory care facility)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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