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

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

Study Overview

• Status: Terminated
• Conditions: Nutrition Disorders; Malnutrition
• Intervention / Treatment: Dietary supplement: Oral nutrition supplement; Other: Nutritional advice

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.

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Córdoba, Andalucía, Spain
      • Complejo Hospitalario Regional Reina Sofía
  • Aragón
    • Zaragoza, Aragón, Spain
      • Hospital Clinico Universitario Lozano Blesa
  • Castilla Y León
    • León, Castilla Y León, Spain, 24008
      • Complejo Asistencial Universitario de León
    • Segovia, Castilla Y León, Spain
      • Complejo Asistencial de Segovia
  • Cataluña
    • Badalona, Cataluña, Spain
      • Hospital Universitari Germans Trias I Pujol de Badalona
    • Tarragona, Cataluña, Spain
      • Hospital Universitari Joan Xxiii de Tarragona
  • Toledo
    • Talavera De La Reina, Toledo, Spain
      • Hospital General Nuestra Señora del Prado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 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; Hypercaloric and high protein supplement; Other: Nutritional advice; Advice given by the clinician
ACTIVE_COMPARATOR: Control group; Participants in the control group will receive nutrition advice	Other: Nutritional advice; Advice given by the clinician

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
• Collaborators: WEBER Economía y Salud S.L.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2019
• Primary Completion (ACTUAL): May 11, 2022
• Study Completion (ACTUAL): May 11, 2022

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: cost-effectiveness; nutritional supplement; cost-utility
• Additional Relevant MeSH Terms: Malnutrition; Nutrition Disorders
• Other Study ID Numbers: 01_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No