Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT03555461
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2018-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine
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': 'ACTUAL', 'count': 563}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence or absence of malnutrition', 'timeFrame': 'The inclusion day', 'description': 'presence or absence of malnutrition based on BMI and / or percentage of weight loss'}, {'measure': 'Score EPA', 'timeFrame': 'The inclusion day', 'description': 'score obtained with the EPA® tool (assessment of food intake)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting a general practioner in his activity of substitute doctor,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be an adult,\n* Consulting the principal investigator, a general practitioner in his activity of substitute doctor,\n* During the inclusion period,\n* Not opposed to participating in the study.\n\nExclusion Criteria:\n\n* Patients benefiting from artificial nutrition,\n* Patients with advanced dementia,\n* Pregnant or postpartum women,\n* Patients who do not understand or speak French,\n* Patients treated with diuretics who have had a change in treatment dosage during the last 6 months,\n* Patients for whom weight measurement is not possible in the office (wheelchair, disability ...),\n* Patients who have already been included once,\n* Patients who have had surgery for obesity,\n* Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty, ...'}, 'identificationModule': {'nctId': 'NCT03555461', 'acronym': 'GEN-EPA', 'briefTitle': 'Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine', 'orgStudyIdInfo': {'id': '35RC17_3087-GEN-EPA'}}, 'contactsLocationsModule': {'locations': [{'zip': '35690', 'city': 'Acigné', 'country': 'France', 'facility': 'Cabinet médical des Rosiers', 'geoPoint': {'lat': 48.13538, 'lon': -1.5337}}, {'zip': '56240', 'city': 'Berné', 'country': 'France', 'facility': 'Cabinet médical des Docteurs Le Vagueres et Godard,', 'geoPoint': {'lat': 47.9953, 'lon': -3.39208}}, {'zip': '56440', 'city': 'Languidic', 'country': 'France', 'facility': 'Cabinet médical du Dr Berthier,', 'geoPoint': {'lat': 47.83358, 'lon': -3.15811}}], 'overallOfficials': [{'name': 'Ronan PhD Thibault', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}