Malnutrition, Nutrition Disorders
Conditions
Keywords
nutritional supplement, cost-effectiveness, cost-utility
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTOral nutrition supplement
Hypercaloric and high protein supplement
OTHERNutritional advice
Advice given by the clinician
Sponsors
WEBER Economía y Salud S.L.
Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Medical doctor visits | from randomization to 6 months | Visits to any outpatient medical office |
| Strength | from baseline-12 weeks | hand grip strength test |
| Number of Hospital admittance | at 30 days | Number of admittance from randomization |
| Number of Hospital admittances | from randomization to 6 months | Number of admittance from randomization |
| Body mass index | baseline | 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 |
| Change in nutritional status | from baseline-12 weeks | 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.) |
| Number of participants Diagnosed of malnutrition | from baseline-12 weeks | Diagnosis of malnutrition using GLIM criteria |
| Health related quality of life | from baseline-12 weeks | EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status) |
| Functional status | from baseline-12 weeks | 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)) |
| Strength and endurance | from baseline-12 weeks | 30-second Chair Stand Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of secondary effects related to the intervention | from randomization to 6 months | Any undesirable effect due to the intervention |
| Number of deaths | from randomization to 6 months | mortality registry |
| Number of Infections | at 6 months | Any diagnosed infection by a medical doctor |
Countries
Spain
Outcome results
None listed