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临床试验/NCT04228900
NCT04228900Unknown不适用

Nutrition and Medication Management in Home-dwelling Older Adults. Study II: Malnutrition in Older Adults: An Intervention Based on Medication Review and Individual Nutritional Plan

University of Oslo1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年8月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Change from Baseline Body weight at 24th week

研究概览

简要总结

The project "Nutrition and Medication management in home-dwelling older adults" consist of two separate studies witch are described in the same study protocol. This is the second study in this Project. The first study (cross sectional) is described separately; Identification: 2017/12883-1

Undernutrition is common in older adults. The causes are many and include drug therapy. Drug side effects, as loss of appetite, nausea, or dry mouth, may contribute to malnutrition, impaired health and loss of function.

In patients with malnutrition or at risk for malnutrition we will evaluate an intervention consisting of:

  • an "individual nutritional plan" with different measures aiming at improving nutritional status.
  • a systematic drug review.

详细描述

The participants will be recruited by the home nursing services or by a nurse at a short-time ward in the nursing home.

The composite intervention consists has two components (A and B):

Component A: Clinical assessment and critical medication review

Drawing on information from the medical history, clinical finding according to examination made by the principal investigator (trained physician), information from the General Practitioner (GP) and the findings from blood tests, we will make a systematic and critical medication review. This systematic review has the following considerations:

  • Are drug-drug unintended interactions likely to occur? Interaction analysis supported by https:// www.interaksjoner.no
  • Are there use of potentially inappropriate medication? Assessed based on the Norwegian General Practice Nursing -Home criteria.
  • Could nutritional related problems like loss of appetite, dry mouth and nausea, be attribute to adverse drug effects? Assessed by the list we made of drugs who often contributes to these side effects according to The Norwegian Pharmaceutical Product Compendium.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Age 70 year or more
  • Receiving home nurse care each second week or more often
  • Mini Nutritional Assessment short form (MNA-SF): 0-11 point (malnourished or at risk for malnutrition)

排除标准

  • Life expectance less than 6 month
  • Serious cognitive impairment
  • In need of enteral-/ parenteral nutrition
  • Not able to stand up for weight measure
  • The home care service are not responsible for medication delivery.

研究组 & 干预措施

Intervention group

Experimental

Drug review and tailored nutritional supply.

干预措施: Individualized plan for improvement of nutrition (Dietary Supplement)

Intervention group

Experimental

Drug review and tailored nutritional supply.

干预措施: Systematic drug review (Drug)

结局指标

主要结局

Change from Baseline Body weight at 24th week

时间窗: Baseline, 24th week

measurement of the participants weight

次要结局

  • Change from Baseline Health- related quality of life at 24th week(Baseline, 24th week)
  • Change from Baseline Activity of Daily living (ADL) at 24th week(Baseline, 24th week)
  • Change from Baseline Admission to nursing home at 24th week(Baseline, 24th week)
  • Change from Baseline Admission to hospital at 24th week(Baseline, 24th week)
  • Change from Baseline Mini Nutritional Assessment short form (MNA-SF) at 24th week(Baseline, 24th week)
  • Change from Baseline Number of drugs in daily use at 24th week(Baseline, 24th week)
  • Change from Baseline Number of drugs in daily use considered inappropriate at 24th week(Baseline, 24th week)
  • Change from Baseline Number of drugs in daily with high risk causing nausea, loss of appetite, and dry mouth at 24th week.(Baseline, 24th week)

研究者

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

Mari Fiske

Principal investigator

University of Oslo

研究点 (1)

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