Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-11 @ 5:25 PM
Study NCT ID:
NCT02122120
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2014-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Aritficial Diet and Complex Care in Home Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 456}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-23', 'studyFirstSubmitDate': '2014-04-19', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': '24 months'}], 'primaryOutcomes': [{'measure': 'Number of complications', 'timeFrame': '24 moths'}], 'secondaryOutcomes': [{'measure': 'Number of hospital admissions', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['enteral nutrition, tube feeding, nutritional support'], 'conditions': ['Dietary Modification']}, 'referencesModule': {'references': [{'pmid': '23528323', 'type': 'BACKGROUND', 'citation': 'Majka AJ, Wang Z, Schmitz KR, Niesen CR, Larsen RA, Kinsey GC, Murad AL, Prokop LJ, Murad MH. Care coordination to enhance management of long-term enteral tube feeding: a systematic review and meta-analysis. JPEN J Parenter Enteral Nutr. 2014 Jan;38(1):40-52. doi: 10.1177/0148607113482000. Epub 2013 Mar 25.'}, {'pmid': '24965306', 'type': 'DERIVED', 'citation': 'Klek S, Hermanowicz A, Dziwiszek G, Matysiak K, Szczepanek K, Szybinski P, Galas A. Home enteral nutrition reduces complications, length of stay, and health care costs: results from a multicenter study. Am J Clin Nutr. 2014 Aug;100(2):609-15. doi: 10.3945/ajcn.113.082842. Epub 2014 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently.\n\nObjective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.', 'detailedDescription': 'Background: Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently.\n\nObjective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.\n\nDesign: The observational multicentre study in the group of 456 HEN patients was performed between January 2007 and July 2013. Two twelve-month periods were compared. During the first one patients were tube fed with home-made diet without monitoring, while during the other the complex HEN was carried out. The latter included tube feeding and complex monitoring by nutrition support team. Number of complications, hospital admissions, length of hospital stay (LOS), biochemical and anthropometric parameters and costs of hospitalization were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '456 patients during home tube feeding', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indications for home tube feeding (HTF),\n* complete present and past medical history,\n* tube feeding for at least twelve months before HEN and at least twelve months afterwards.\n\nExclusion Criteria:\n\n* doubtful indications for HEN, no access or an incomplete medical record,\n* treatment period shorter than 12 months either before or after enrolment'}, 'identificationModule': {'nctId': 'NCT02122120', 'briefTitle': 'The Value of Aritficial Diet and Complex Care in Home Nutrition', 'organization': {'class': 'OTHER', 'fullName': "Stanley Dudrick's Memorial Hospital"}, 'officialTitle': 'Home Enteral Nutrition (HEN) Reduces Complications, Length of Stay and Health-care Costs: Results From the Multicenter Study.', 'orgStudyIdInfo': {'id': 'HEN1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before HEN', 'description': 'Patients with tube feeding with kitchen diet for at least twelve months', 'interventionNames': ['Dietary Supplement: HEN']}], 'interventions': [{'name': 'HEN', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients with tube feeding with FSMP for at least twelve months', 'armGroupLabels': ['Before HEN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32-050', 'city': 'Skawina', 'state': 'Malopolska', 'country': 'Poland', 'facility': "Stanley Dudrick's Memorial Hospital", 'geoPoint': {'lat': 49.97524, 'lon': 19.82869}}], 'overallOfficials': [{'name': 'Stanislaw Klek, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Stanley Dudrick's Memorial Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Stanley Dudrick's Memorial Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Departement', 'investigatorFullName': 'Stanislaw Klek', 'investigatorAffiliation': "Stanley Dudrick's Memorial Hospital"}}}}