Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT03944161
Status:
TERMINATED
Last Update Posted:
2022-05-19
First Post:
2019-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'whyStopped': 'The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-13', 'studyFirstSubmitDate': '2019-04-15', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index', 'timeFrame': 'baseline', '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"}, {'measure': 'Body mass index', 'timeFrame': '12 weeks', '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"}, {'measure': 'Body mass index', 'timeFrame': '6 months', '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"}, {'measure': 'Change in nutritional status', 'timeFrame': 'from baseline-12 weeks', '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.)'}, {'measure': 'Change in nutritional status', 'timeFrame': 'from basal-6 months', '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.)'}, {'measure': 'Number of participants Diagnosed of malnutrition', 'timeFrame': 'from baseline-12 weeks', 'description': 'Diagnosis of malnutrition using GLIM criteria'}, {'measure': 'Number of participants Diagnosed of malnutrition', 'timeFrame': 'from baseline-6 months', 'description': 'Diagnosis of malnutrition using GLIM criteria'}, {'measure': 'Health related quality of life', 'timeFrame': 'from baseline-12 weeks', 'description': 'EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)'}, {'measure': 'Health related quality of life', 'timeFrame': 'from baseline-6 months', 'description': 'EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)'}, {'measure': 'Functional status', 'timeFrame': 'from baseline-12 weeks', '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))'}, {'measure': 'Functional status', 'timeFrame': 'from baseline-6 months', '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))'}, {'measure': 'Strength and endurance', 'timeFrame': 'from baseline-12 weeks', 'description': '30-second Chair Stand Test'}, {'measure': 'Strength and endurance', 'timeFrame': 'from baseline-6 months', 'description': '30-second Chair Stand Test'}, {'measure': 'Strength', 'timeFrame': 'from baseline-12 weeks', 'description': 'hand grip strength test'}, {'measure': 'Strength', 'timeFrame': 'from baseline-6 months', 'description': 'hand grip strength test'}, {'measure': 'Number of Hospital admittance', 'timeFrame': 'at 30 days', 'description': 'Number of admittance from randomization'}, {'measure': 'Number of Hospital admittances', 'timeFrame': 'from randomization to 6 months', 'description': 'Number of admittance from randomization'}, {'measure': 'Number of Medical doctor visits', 'timeFrame': 'from randomization to 6 months', 'description': 'Visits to any outpatient medical office'}], 'secondaryOutcomes': [{'measure': 'Number of deaths', 'timeFrame': 'from randomization to 6 months', 'description': 'mortality registry'}, {'measure': 'Number of Infections', 'timeFrame': 'at 6 months', 'description': 'Any diagnosed infection by a medical doctor'}, {'measure': 'Number of secondary effects related to the intervention', 'timeFrame': 'from randomization to 6 months', 'description': 'Any undesirable effect due to the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutritional supplement', 'cost-effectiveness', 'cost-utility'], 'conditions': ['Malnutrition', 'Nutrition Disorders']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.', 'detailedDescription': '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...\n\nUnitary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 y\n* Nutritional status B or C (GSA criteria)\n* Presenting one of the following conditions:\n* Cancer patient after surgery, radiotherapy on antineoplastic treatment.\n* Hip fracture\n* Heart failure NYHA (New York Heart Association) III-IV.\n* Breathing failure GOLD 3 o 4: FEV1 (forced expiratory volume at one second ) \\<50%.\n* Renal failure GFR\\<30 (glomerular filtration rate )\n* Participants agreeing the informed consent\n\nExclusion Criteria:\n\n* Cancer patients: esophagus, stomach, pancreas and Head and neck\n* Hospital admitted patients at the time of recruitment\n* Life expectancy below 3 months\n* Pregnant or nursing women\n* Use of oral nutritional supplements in the three months prior the enrolment\n* History of allergy to oral nutritional supplements\n* Diabetes mellitus type 1.\n* Participation in any other study at the time of enrolment\n* Cognitive limitations to participate in the study'}, 'identificationModule': {'nctId': 'NCT03944161', 'acronym': 'COSENUT', 'briefTitle': 'Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral'}, 'officialTitle': 'Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain', 'orgStudyIdInfo': {'id': '01_2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', '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.', 'interventionNames': ['Dietary Supplement: Oral nutrition supplement', 'Other: Nutritional advice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants in the control group will receive nutrition advice', 'interventionNames': ['Other: Nutritional advice']}], 'interventions': [{'name': 'Oral nutrition supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hypercaloric and high protein supplement', 'armGroupLabels': ['Intervention group']}, {'name': 'Nutritional advice', 'type': 'OTHER', 'description': 'Advice given by the clinician', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Córdoba', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Complejo Hospitalario Regional Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Zaragoza', 'state': 'Aragon', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '24008', 'city': 'León', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Complejo Asistencial Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Segovia', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Complejo Asistencial de Segovia', 'geoPoint': {'lat': 40.94808, 'lon': -4.11839}}, {'city': 'Badalona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias I Pujol de Badalona', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Tarragona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Universitari Joan Xxiii de Tarragona', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'city': 'Talavera de la Reina', 'state': 'Toledo', 'country': 'Spain', 'facility': 'Hospital General Nuestra Señora Del Prado', 'geoPoint': {'lat': 39.96348, 'lon': -4.83076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral', 'class': 'OTHER'}, 'collaborators': [{'name': 'WEBER Economía y Salud S.L.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}