Clinical trial NCT03944161: Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
Official title: Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malnutrition
Nutrition Disorders
Keywords: nutritional supplement
cost-effectiveness
cost-utility
Lead sponsor: Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
Sponsor class: OTHER
Collaborators: name: WEBER Economía y Salud S.L.
First posted: 2019-05-09
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Body mass index
timeFrame: baseline
measure: Body mass index
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 6 months
measure: Change in nutritional status
timeFrame: from baseline-12 weeks
measure: Change in nutritional status
timeFrame: from basal-6 months
measure: Number of participants Diagnosed of malnutrition
timeFrame: from baseline-12 weeks
measure: Number of participants Diagnosed of malnutrition
timeFrame: from baseline-6 months
measure: Health related quality of life
timeFrame: from baseline-12 weeks
measure: Health related quality of life
timeFrame: from baseline-6 months
measure: Functional status
timeFrame: from baseline-12 weeks
measure: Functional status
timeFrame: from baseline-6 months
measure: Strength and endurance
timeFrame: from baseline-12 weeks
measure: Strength and endurance
timeFrame: from baseline-6 months
measure: Strength
timeFrame: from baseline-12 weeks
measure: Strength
timeFrame: from baseline-6 months
measure: Number of Hospital admittance
timeFrame: at 30 days
measure: Number of Hospital admittances
timeFrame: from randomization to 6 months
measure: Number of Medical doctor visits
timeFrame: from randomization to 6 months
Secondary outcomes:
measure: Number of deaths
timeFrame: from randomization to 6 months
measure: Number of Infections
timeFrame: at 6 months
measure: Number of secondary effects related to the intervention
timeFrame: from randomization to 6 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Complejo Hospitalario Regional Reina Sofía
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
state: Aragón
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
state: Castilla Y León
city: Segovia
country: Spain
facility: Complejo Asistencial de Segovia
state: Castilla Y León
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol de Badalona
state: Cataluña
city: Tarragona
country: Spain
facility: Hospital Universitari Joan Xxiii de Tarragona
state: Cataluña
city: Talavera De La Reina
country: Spain
facility: Hospital General Nuestra Señora Del Prado
state: Toledo
Study officials:
References: