Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-29 @ 9:17 PM
Study NCT ID:
NCT03679832
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients
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': 1670}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Length of Stay', 'timeFrame': 'From Date of Admission until Date of Discharge or Death from any cause, assessed through follow up (30-day Post Discharge)', 'description': 'Chart Review'}], 'secondaryOutcomes': [{'measure': 'Healthcare Resource Utilization', 'timeFrame': 'Hospital Admission to 30-day Post Discharge', 'description': 'Chart Review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'This study includes pre and post-Quality Improvement Program groups. A nutrition-focused Quality Improvement Program will be implemented to assess the health and economic outcomes in malnourished hospitalized patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to a single-site in Vietnam meeting eligibility criteria for retrospective or prospective participation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at risk / malnourished, defined by an MST score ≥ 2 the first 24 hours post hospital admission\n* Patients are admitted for the following diagnoses: Respiratory, Digestive Surgery, Cardiology, General Internal Medicine (including Endocrinology), and Gastrointestinal\n* Patient is able to consume foods and beverages orally\n* Patients with life expectancy ≥ 30 days\n* Patient is literate and willing to voluntarily sign and date Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Subject has severe dementia or delirium and has no dedicated caregiver who could assure their compliance with QIP study requirements\n* Subject has an eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures\n* Subject is known to be allergic or intolerant to any ingredient found in the study products\n* Subject is pregnant\n* Subject is intubated, receiving tube feeding or parenteral nutrition'}, 'identificationModule': {'nctId': 'NCT03679832', 'briefTitle': 'A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Assessing the Impact of A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients in an Academic University Hospital in Vietnam', 'orgStudyIdInfo': {'id': 'HA32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Historical Group 1', 'description': 'Patients admitted at UMC between September 2015 and October 2016'}, {'label': 'Historical Group 2', 'description': 'Patients admitted at UMC between November 2016 and up to the beginning of the QIP'}, {'label': 'Nutrition-Focused QIP', 'description': 'Patients admitted at UMC that meet eligibility criteria and prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption 30-days post discharge'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University Medical Center', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Suela Sulo, PhD,MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Medical Center, Vietnam', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}