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

Malnutrition Clinical Trial

— COSENUT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03944161
• Other study ID #: 01_2019
• Status: Terminated
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: May 11, 2022

Study information

• Verified date: May 2022
• Source: Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 380
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Nutrition Disorders

Intervention

Dietary Supplement:
• Oral nutrition supplement
Hypercaloric and high protein supplement

Other:
• Nutritional advice
Advice given by the clinician

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias I Pujol de Badalona	Badalona	Cataluña
Spain	Complejo Hospitalario Regional Reina Sofía	Córdoba	Andalucía
Spain	Complejo Asistencial Universitario de León	León	Castilla Y León
Spain	Complejo Asistencial de Segovia	Segovia	Castilla Y León
Spain	Hospital General Nuestra Señora Del Prado	Talavera De La Reina	Toledo
Spain	Hospital Universitari Joan Xxiii de Tarragona	Tarragona	Cataluña
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza	Aragón

Sponsors (2)

Lead Sponsor	Collaborator
Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral	WEBER Economía y Salud S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of participants Diagnosed of malnutrition	Diagnosis of malnutrition using GLIM criteria	from baseline-12 weeks
Primary	Number of participants Diagnosed of malnutrition	Diagnosis of malnutrition using GLIM criteria	from baseline-6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Strength and endurance	30-second Chair Stand Test	from baseline-12 weeks
Primary	Strength and endurance	30-second Chair Stand Test	from baseline-6 months
Primary	Strength	hand grip strength test	from baseline-12 weeks
Primary	Strength	hand grip strength test	from baseline-6 months
Primary	Number of Hospital admittance	Number of admittance from randomization	at 30 days
Primary	Number of Hospital admittances	Number of admittance from randomization	from randomization to 6 months
Primary	Number of Medical doctor visits	Visits to any outpatient medical office	from randomization to 6 months
Secondary	Number of deaths	mortality registry	from randomization to 6 months
Secondary	Number of Infections	Any diagnosed infection by a medical doctor	at 6 months
Secondary	Number of secondary effects related to the intervention	Any undesirable effect due to the intervention	from randomization to 6 months