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临床试验/NCT02251496
NCT02251496已完成不适用

Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks, Weight Changes and Functional Capacity in Chronic Obstructive Pulmonary Disease; Randomized Controlled Dietary Intervention

University of Iceland2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Weight Changes

研究概览

简要总结

At least one fifth of patients in European hospitals are malnourished. Malnutrition is associated with negative consequences, including higher rates of complications, longer hospital stay, impaired wound healing and increased mortality with consequent effects on costs of healthcare. Evidence suggests that there may be benefits to some malnourished patients from receiving oral nutrition supplements in the short-term but it is not known whether these benefits can be sustained and indeed whether similar benefits may be achieved using food-based interventions of lower cost. The overall objective of the study is to compare two nutritional interventions among malnourished patients with COPD (n=200); oral nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is weight change. Secondary endpoints include forced expiratory volume in one second, forced vital capacity, six-minute walk distance, hand-grip strength, health related quality of life, length of hospital stay, energy- and protein intake, readmissions to the hospital and acute exacerbation. No studies are available comparing the supply of ONS to malnourished patients with COPD compared with the provision of regular food (in-between meals snacks). The results of the study will provide important information that might improve nutrition care in the hospital setting as well as after discharge from the hospital

详细描述

Patients with established COPD admitted to the Department of Pulmonary Medicine at Landspitali National University Hospital from September 2014-September 2016 will be screened for malnutrition using the NRS2002 screening tool, recommended by ESPEN. Those identified at risk of malnutrition and are able to give informed consent will be recruited. According to the Hospital statistics and previous studies on the frequency of malnutrition in this patient group, the time frame for recruitment is long enough to recruit 200 subjects who will be randomised into the two study groups (~ 3 subjects per week).

The following baseline data will be collected in order to identify possible confounders. This will include; socio-demographic data (age, gender, civil status, household size, family and social network); major medical diagnosis; use of medication; GOLD score (Global Initiative for Chronic Obstructive Lung Disease), depressive symptoms, cognition), additional discharge interventions (e.g. outgoing hospital teams, day care with exercise); and use of oral nutritional supplements.

Inclusion criteria are:

  • Newly admitted patients > 18 years old who were at nutritional risk according to the validated nutritional risk screening tool (NRS-2002, score 3+)
  • Able to eat orally
  • An anticipated length of hospitalization of > 3 days
  • Sufficient language proficiency

Exclusion criteria are:

研究设计

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

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

  • Newly admitted patients > 18 years old who were at nutritional risk according to the validated nutritional risk screening tool (NRS-2002, score 3+)
  • Able to eat orally
  • An anticipated length of hospitalization of > 3 days
  • Sufficient language proficiency

排除标准

  • Dysphagia
  • Food allergy or intolerance
  • Anatomical obstructions preventing oral food intake
  • Exclusion during follow-up: Subjects who withdraw their consent to participate.

结局指标

主要结局

Weight Changes

时间窗: baseline and one year from admission to the hospital

Weight changes from baseline and one year from admission to the hospital

次要结局

  • Health Related Quality of Life (HRQoL)(baseline and one year from admission to the hospital)

研究者

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

Áróra Rós Ingadóttir

Nutritionist M.Sc

University of Iceland

研究点 (2)

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