Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT04244851
Status:
UNKNOWN
Last Update Posted:
2020-03-05
First Post:
2019-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-10-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2020-01-27', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evolution of malnutrition after hospital discharge', 'timeFrame': '3 months after discharge', 'description': 'Malnutrition diagnostic criteria defined by the French Health Authority :\n\n* If age ≥ 70 years old : weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI \\< 21 kg/m² and/or serum albumin level \\< 35 g/l\n* If age \\< 70 years old: weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI \\< 18,5 kg/m² level'}], 'secondaryOutcomes': [{'measure': 'Describe the path of care following the hospitalization of patients diagnosed with malnutrition at the hospital', 'timeFrame': '3 months after discharge', 'description': '* Number of hospital readmissions\n* Number of family physician consultations'}, {'measure': 'Evaluate appropriation of patient regarding malnutrition', 'timeFrame': '3 months after discharge', 'description': 'Qualitative study by semi-structured patient interviews'}, {'measure': 'Evaluate the perception of patient regarding malnutrition', 'timeFrame': '3 months after discharge', 'description': 'Qualitative study by semi-structured patient interviews'}, {'measure': 'Evaluate expectations of patient regarding malnutrition', 'timeFrame': '3 months after discharge', 'description': 'Qualitative study by semi-structured patient interviews'}, {'measure': 'Evaluate the needs of health professionals regarding undernutrition', 'timeFrame': '3 months after discharge', 'description': 'Qualitative study by semi-structured patient interviews'}, {'measure': 'Evaluate the expectations of health professionals regarding undernutrition', 'timeFrame': '3 months after discharge', 'description': 'Qualitative study by semi-structured patient interviews'}, {'measure': 'Evaluate knowledge of health professionals regarding undernutrition', 'timeFrame': '3 months after discharge', 'description': 'Qualitative study by semi-structured patient interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malnutrition,', 'qualitative study'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge.\n\nThis study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.', 'detailedDescription': 'All patients hospitalized in the post-emergency unit of Rennes University Hospital during the study period will be screened for malnutrition.\n\nData concerning newly diagnosed malnourished patients will be recorded and those patients will be contacted 3 months after their hospital discharge.\n\nA qualitative study will be conducted among malnourished patients and their families : a sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Malnourished patients diagnosed during their hospitalization in the post-emergency unit of Rennes Universisty Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malnourished patients, hospitalized in the post-emergency unit during the study period, according to the malnutrition diagnostic criteria defined by the French Health Authority :\n* age ≥ 70 years old: weight loss ≥ 5% within 1 month or ≥ 10% within 6 months and/or BMI \\<21 and or serum albumin level \\< 35 g/l\n* age \\< 70 years old : weight loss ≥ 5% in 1 month or ≥ 10% in 6 months or ≥ 10% compared to the usual weight before the onset of the disease; or BMI \\<18.5 kg / m2\n\nNon-inclusion criteria :\n\n* refusing to participate in the study\n* age \\< 18 years old\n* patients under tutorship or guardianship\n* patients living in retirement home\n* Patients without a fixed address\n\nExclusion criteria :\n\n-patients transferred in another unit'}, 'identificationModule': {'nctId': 'NCT04244851', 'acronym': 'Nutriker', 'briefTitle': 'Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission', 'orgStudyIdInfo': {'id': '35RC19_30034_NUTRIKer'}, 'secondaryIdInfos': [{'id': '2019-A01809-48', 'type': 'OTHER', 'domain': 'ansm'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Malnourished patients', 'description': 'Malnourished patients', 'interventionNames': ['Other: Malnourished patients']}], 'interventions': [{'name': 'Malnourished patients', 'type': 'OTHER', 'description': 'Data of included patients will be recorded during hospitalization using medical charts.\n\nEvery patient will be contacted by phone 3 months after hospital discharge. A sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.', 'armGroupLabels': ['Malnourished patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lilian Alix', 'role': 'CONTACT', 'email': 'lilian.alix@chu-rennes.fr'}, {'name': 'Lilian Alix', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'cecile ferragu', 'role': 'CONTACT', 'email': 'cecile.ferragu@chu-rennes.fr', 'phone': '0299282555'}, {'name': 'DRI Direction de la recherhce clinique', 'role': 'CONTACT', 'email': 'dri@chu-rennes.fr', 'phone': '0299282555'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}