Departments of Nutrition and Dietetics, Internal Medicine and EMGO+ institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.
Nutr J. 2010 Feb 10;9:6. doi: 10.1186/1475-2891-9-6.
Malnutrition is a common consequence of disease in older patients. Both in hospital setting and in community setting oral nutritional support has proven to be effective. However, cost-effectiveness studies are scarce. Therefore, the aim of our study is to investigate the effectiveness and cost-effectiveness of transmural nutritional support in malnourished elderly patients, starting at hospital admission until three months after discharge.
This study is a randomized controlled trial. Patients are included at hospital admission and followed until three months after discharge. Patients are eligible to be included when they are > or = 60 years old and malnourished according to the following objective standards: Body Mass Index (BMI in kg/m2) < 20 and/or > or = 5% unintentional weight loss in the previous month and/or > or = 10% unintentional weight loss in the previous six months. We will compare usual nutritional care with transmural nutritional support (energy and protein enriched diet, two additional servings of an oral nutritional supplement, vitamin D and calcium supplementation, and consultations by a dietitian). Each study arm will consist of 100 patients. The primary outcome parameters will be changes in activities of daily living (determined as functional limitations and physical activity) between intervention and control group. Secondary outcomes will be changes in body weight, body composition, quality of life, and muscle strength. An economic evaluation from a societal perspective will be conducted alongside the randomised trial to evaluate the cost-effectiveness of the intervention in comparison with usual care.
In this randomized controlled trial we will evaluate the effect of transmural nutritional support in malnourished elderly patients after hospital discharge, compared to usual care. Primary endpoints of the study are changes in activities of daily living, body weight, body composition, quality of life, and muscle strength. An economic evaluation will be performed to evaluate the cost-effectiveness of the intervention in comparison with usual care.
Netherlands Trial Register (ISRCTN29617677, registered 14-Sep-2005).
营养不良是老年患者疾病的常见后果。无论是在医院环境还是社区环境中，口服营养支持都已被证明是有效的。然而，成本效益研究却很少。因此，我们的研究目的是调查营养不良的老年患者在住院期间至出院后三个月内进行跨壁营养支持的有效性和成本效益。
这是一项随机对照试验。患者在入院时纳入并随访至出院后三个月。当患者年龄大于或等于 60 岁且根据以下客观标准营养不良时，有资格被纳入：体重指数（BMI，kg/m2）<20 和/或在过去一个月内非故意体重减轻>或等于 5%，或在过去六个月内非故意体重减轻>或等于 10%。我们将比较常规营养护理与跨壁营养支持（能量和蛋白质丰富的饮食、两种额外的口服营养补充剂、维生素 D 和钙补充剂以及营养师咨询）。每个研究组将包括 100 名患者。主要结局参数将是干预组和对照组之间日常生活活动（确定为功能障碍和体力活动）的变化。次要结局将是体重、身体成分、生活质量和肌肉力量的变化。一项从社会角度进行的经济评估将与随机试验同时进行，以评估干预措施与常规护理相比的成本效益。
在这项随机对照试验中，我们将评估跨壁营养支持在出院后营养不良的老年患者中的效果，与常规护理相比。该研究的主要终点是日常生活活动、体重、身体成分、生活质量和肌肉力量的变化。将进行经济评估，以评估与常规护理相比干预措施的成本效益。
荷兰试验注册处（ISRCTN29617677，2005 年 9 月 14 日注册）。
