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The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated.
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| Name | Class |
|---|---|
| WEBER Economía y Salud S.L. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | Active Comparator | Participants in the control group will receive nutrition advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral nutrition supplement | Dietary Supplement | Hypercaloric and high protein supplement |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of deaths | mortality registry | from randomization to 6 months |
| Number of Infections | Any diagnosed infection by a medical doctor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Regional Reina Sofía | Córdoba | Andalusia | Spain | |||
| Hospital Clínico Universitario Lozano Blesa |
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| Nutritional advice | Other | Advice given by the clinician |
|
| 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 |
| at 6 months |
| Number of secondary effects related to the intervention | Any undesirable effect due to the intervention | from randomization to 6 months |
| Zaragoza |
| Aragon |
| Spain |
| Complejo Asistencial Universitario de León | León | Castille and León | 24008 | Spain |
| Complejo Asistencial de Segovia | Segovia | Castille and León | Spain |
| Hospital Universitari Germans Trias I Pujol de Badalona | Badalona | Catalonia | Spain |
| Hospital Universitari Joan Xxiii de Tarragona | Tarragona | Catalonia | Spain |
| Hospital General Nuestra Señora Del Prado | Talavera de la Reina | Toledo | Spain |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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