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

Primary Purpose

Malnutrition, Nutrition Disorders

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oral nutrition supplement
Nutritional advice
Sponsored by
Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring nutritional supplement, cost-effectiveness, cost-utility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Complejo Hospitalario Regional Reina Sofía
  • Hospital Clínico Universitario Lozano Blesa
  • Complejo Asistencial Universitario de León
  • Complejo Asistencial de Segovia
  • Hospital Universitari Germans Trias I Pujol de Badalona
  • Hospital Universitari Joan Xxiii de Tarragona
  • Hospital General Nuestra Señora Del Prado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

Participants in the control group will receive nutrition advice

Outcomes

Primary Outcome Measures

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
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
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
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.)
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.)
Number of participants Diagnosed of malnutrition
Diagnosis of malnutrition using GLIM criteria
Number of participants Diagnosed of malnutrition
Diagnosis of malnutrition using GLIM criteria
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)
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)
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))
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))
Strength and endurance
30-second Chair Stand Test
Strength and endurance
30-second Chair Stand Test
Strength
hand grip strength test
Strength
hand grip strength test
Number of Hospital admittance
Number of admittance from randomization
Number of Hospital admittances
Number of admittance from randomization
Number of Medical doctor visits
Visits to any outpatient medical office

Secondary Outcome Measures

Number of deaths
mortality registry
Number of Infections
Any diagnosed infection by a medical doctor
Number of secondary effects related to the intervention
Any undesirable effect due to the intervention

Full Information

First Posted
April 15, 2019
Last Updated
May 13, 2022
Sponsor
Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
Collaborators
WEBER Economía y Salud S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03944161
Brief Title
Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
Acronym
COSENUT
Official Title
Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated.
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
May 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
Collaborators
WEBER Economía y Salud S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Nutrition Disorders
Keywords
nutritional supplement, cost-effectiveness, cost-utility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive nutrition advice
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral nutrition supplement
Intervention Description
Hypercaloric and high protein supplement
Intervention Type
Other
Intervention Name(s)
Nutritional advice
Intervention Description
Advice given by the clinician
Primary Outcome Measure Information:
Title
Body mass index
Description
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
Title
Body mass index
Description
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
Title
Body mass index
Description
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
Title
Change in nutritional status
Description
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
Title
Change in nutritional status
Description
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
Title
Number of participants Diagnosed of malnutrition
Description
Diagnosis of malnutrition using GLIM criteria
Time Frame
from baseline-12 weeks
Title
Number of participants Diagnosed of malnutrition
Description
Diagnosis of malnutrition using GLIM criteria
Time Frame
from baseline-6 months
Title
Health related quality of life
Description
EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
Time Frame
from baseline-12 weeks
Title
Health related quality of life
Description
EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
Time Frame
from baseline-6 months
Title
Functional status
Description
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))
Time Frame
from baseline-12 weeks
Title
Functional status
Description
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))
Time Frame
from baseline-6 months
Title
Strength and endurance
Description
30-second Chair Stand Test
Time Frame
from baseline-12 weeks
Title
Strength and endurance
Description
30-second Chair Stand Test
Time Frame
from baseline-6 months
Title
Strength
Description
hand grip strength test
Time Frame
from baseline-12 weeks
Title
Strength
Description
hand grip strength test
Time Frame
from baseline-6 months
Title
Number of Hospital admittance
Description
Number of admittance from randomization
Time Frame
at 30 days
Title
Number of Hospital admittances
Description
Number of admittance from randomization
Time Frame
from randomization to 6 months
Title
Number of Medical doctor visits
Description
Visits to any outpatient medical office
Time Frame
from randomization to 6 months
Secondary Outcome Measure Information:
Title
Number of deaths
Description
mortality registry
Time Frame
from randomization to 6 months
Title
Number of Infections
Description
Any diagnosed infection by a medical doctor
Time Frame
at 6 months
Title
Number of secondary effects related to the intervention
Description
Any undesirable effect due to the intervention
Time Frame
from randomization to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Complejo Hospitalario Regional Reina Sofía
City
Córdoba
State/Province
Andalucía
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
State/Province
Aragón
Country
Spain
Facility Name
Complejo Asistencial Universitario de León
City
León
State/Province
Castilla Y León
ZIP/Postal Code
24008
Country
Spain
Facility Name
Complejo Asistencial de Segovia
City
Segovia
State/Province
Castilla Y León
Country
Spain
Facility Name
Hospital Universitari Germans Trias I Pujol de Badalona
City
Badalona
State/Province
Cataluña
Country
Spain
Facility Name
Hospital Universitari Joan Xxiii de Tarragona
City
Tarragona
State/Province
Cataluña
Country
Spain
Facility Name
Hospital General Nuestra Señora Del Prado
City
Talavera De La Reina
State/Province
Toledo
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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