Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in functional limitations and activities of daily living (single validated questionnaire)
研究概览
简要总结
The aim of this study is to assess the benefit of a 3-month intervention with oral nutritional supplements (ONS) in older ambulant patients with reference to functional limitations and quality of life as well as the consumption of health care resources.
详细描述
Study participants are assessed upon discharge from the hospital and again after 3 months. Upon discharge all patients receive nutrition counselling with special focus on an energy rich diet. Additionally, the intervention group receives ONS. The investigators hypothesize an improvement in functional limitations and health economic benefits due to the post-hospital nutritional intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Informed written consent
- •Independent community dwelling after discharge
- •Existing or risk of malnutrition
- •Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
- •Life expectancy of > 3 months according to treating doctor
- •No severe heart disease (New York Heart Association (NYHA) functional classification of 3+), liver disease (Child Pugh Score = A, B) or kidney insufficiency (glomerular filtration rate < 30 ml/min)
- •No chemo or radiation therapy
- •No derailed diabetes mellitus or metabolic decompensation
排除标准
- •Age < 60 years
- •Lack of informed written consent
- •Dependent living conditions after discharge
- •No risk of malnutrition
- •Low cognitive status according to Mini-Mental State Examination (MMSE < 24 points)
- •Life expectancy of < 3 months according to treating doctor
- •Severe heart disease (New York Heart Association (NYHA) functional classification of 3+), liver disease (Child Pugh Score = C) or kidney insufficiency (glomerular filtration rate < 30 ml/min)
- •Chemo or radiation therapy
- •Derailed diabetes mellitus or metabolic decompensation
结局指标
主要结局
Change in functional limitations and activities of daily living (single validated questionnaire)
时间窗: Baseline (hospital discharge) and after 3 months
次要结局
- Consumption of health care resources (questionnaire) and cost analysis(From baseline (hospital discharge) during subsequent 3 months)
- Functional Parameter: timed up & go(Baseline (hospital discharge) and after 3 months)
- Functional Parameter: stair climbing(Baseline (hospital discharge) and after 3 months)
- Strength Parameter: Hand grip strength(Baseline (hospital discharge) and after 3 months)
- Functional Parameter: gait analysis(Baseline (hospital discharge) and after 3 months)
- Strength Parameter: Knee extension strength(Baseline (hospital discharge) and after 3 months)
- Functional Parameter: lung function(Baseline (hospital discharge) and after 3 months)
- Quality of life (validated questionnaire)(Baseline (hospital discharge) and after 3 months)
- Body composition (bioelectric impedance analysis)(Baseline (hospital discharge) and after 3 months)
研究者
Kristina Norman
PD Dr. Kristina Norman
Charite University, Berlin, Germany