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

Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral380 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

380

Conditions

Malnutrition Nutrition Disorders

Interventions

Oral nutrition supplementDIETARY_SUPPLEMENT

Hypercaloric and high protein supplement

Nutritional adviceOTHER

Advice given by the clinician

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Complejo Hospitalario Regional Reina Sofía

Córdoba, Andalusia, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

Complejo Asistencial Universitario de León

León, Castille and León, Spain

Complejo Asistencial de Segovia

Segovia, Castille and León, Spain

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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.)

Time frame: 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.)

Time frame: from basal-6 months

Number of participants Diagnosed of malnutrition

Diagnosis of malnutrition using GLIM criteria

Time frame: from baseline-12 weeks

Number of participants Diagnosed of malnutrition

Diagnosis of malnutrition using GLIM criteria

Time frame: 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)

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes