Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain

Study Overview
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Brief Summary
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The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.

Detailed Description
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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.

Official Title
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Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain

Conditions
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Malnutrition, Nutrition Disorders

Intervention / Treatment
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* Dietary Supplement: Oral nutrition supplement
* Other: Nutritional advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 y 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 Exclusion Criteria: 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 1. Participation in any other study at the time of enrolment Cognitive limitations to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants in the intervention group will receive an oral nutrition supplement bottle (200/220 ml) with >20 % of protein and 1.5 Kcal/ml without fibre twice a day during 12 weeks and nutritional advice. | Dietary Supplement: Oral nutrition supplement<br>* Hypercaloric and high protein supplement<br>Other: Nutritional advice<br>* Advice given by the clinician<br>|
| Active Comparator: Control group<br>Participants in the control group will receive nutrition advice | Other: Nutritional advice<br>* Advice given by the clinician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | 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 | baseline | 
| Body mass index | 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 | 12 weeks | 
| Body mass index | 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 | 6 months | 
| Change in nutritional status | 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.) | from baseline-12 weeks | 
| Change in nutritional status | 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.) | from basal-6 months | 
| Number of participants Diagnosed of malnutrition | Diagnosis of malnutrition using GLIM criteria | from baseline-12 weeks | 
| Number of participants Diagnosed of malnutrition | Diagnosis of malnutrition using GLIM criteria | from baseline-6 months | 
| Health related quality of life | EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status) | from baseline-12 weeks | 
| Health related quality of life | EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status) | from baseline-6 months | 
| Functional status | 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)) | from baseline-12 weeks | 
| Functional status | 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)) | from baseline-6 months | 
| Strength and endurance | 30-second Chair Stand Test | from baseline-12 weeks | 
| Strength and endurance | 30-second Chair Stand Test | from baseline-6 months | 
| Strength | hand grip strength test | from baseline-12 weeks | 
| Strength | hand grip strength test | from baseline-6 months | 
| Number of Hospital admittance | Number of admittance from randomization | at 30 days | 
| Number of Hospital admittances | Number of admittance from randomization | from randomization to 6 months | 
| Number of Medical doctor visits | Visits to any outpatient medical office | from randomization to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of deaths | mortality registry | from randomization to 6 months | 
| Number of Infections | Any diagnosed infection by a medical doctor | at 6 months | 
| Number of secondary effects related to the intervention | Any undesirable effect due to the intervention | from randomization to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional supplement, cost-effectiveness, cost-utility