Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 380
- 试验地点
- 8
- 主要终点
- Body mass index
研究概览
简要总结
The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.
详细描述
COSNUT pretends to assess the cost-effectiveness and cost-utility of oral nutritional supplementation (ONS) in persons with malnutrition and other clinical conditions. The effectiveness will be evaluated by comparing the intervention group having ONS vs a control group only with nutrition advice. The effectiveness and resource use will be collected using quality of life assessment tools, body mass index, change in malnutrition state, number of hospital admissions, medical visits...
Unitary costs for Spain will be extracted from databases and official publications and will be applied to the number of resources used in order to calculate the costs in each of the groups. Finally, the incremental cost-effectiveness ratio will be estimated and presented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Nutritional status B or C (GSA criteria)
- •Presenting one of the following conditions:
- •Cancer patient after surgery, radiotherapy on antineoplastic treatment.
- •Hip fracture
- •Heart failure NYHA (New York Heart Association) III-IV.
- •Breathing failure GOLD 3 o 4: FEV1 (forced expiratory volume at one second ) <50%.
- •Renal failure GFR<30 (glomerular filtration rate )
- •Participants agreeing the informed consent
排除标准
- •Cancer patients: esophagus, stomach, pancreas and Head and neck
- •Hospital admitted patients at the time of recruitment
- •Life expectancy below 3 months
- •Pregnant or nursing women
- •Use of oral nutritional supplements in the three months prior the enrolment
- •History of allergy to oral nutritional supplements
- •Diabetes mellitus type
- •Participation in any other study at the time of enrolment
- •Cognitive limitations to participate in the study
结局指标
主要结局
Body mass index
时间窗: 6 months
Index for relating weight to height. Abbreviated BMI. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared
Strength
时间窗: from baseline-6 months
hand grip strength test
Strength and endurance
时间窗: from baseline-6 months
30-second Chair Stand Test
Change in nutritional status
时间窗: from basal-6 months
Change in the Global Subjective Assessment (this scale categorize participants into A, B or C being A the best nutritional status and C the worst.)
Functional status
时间窗: from baseline-6 months
Katz index (this index categorize in one of 7 categories: A,B,C,D,E,F,G from independent for all functions (A) to dependent for all functions (G))
Number of Hospital admittance
时间窗: at 30 days
Number of admittance from randomization
Number of Hospital admittances
时间窗: from randomization to 6 months
Number of admittance from randomization
Number of participants Diagnosed of malnutrition
时间窗: from baseline-6 months
Diagnosis of malnutrition using GLIM criteria
Health related quality of life
时间窗: from baseline-6 months
EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
Number of Medical doctor visits
时间窗: from randomization to 6 months
Visits to any outpatient medical office
次要结局
- Number of deaths(from randomization to 6 months)
- Number of secondary effects related to the intervention(from randomization to 6 months)
- Number of Infections(at 6 months)