Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT07234669
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2023-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietitian-supported Meal-ordering and Systematic Nutritional Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional intake', 'timeFrame': 'Through study completion, an average of 5 days', 'description': 'Mean daily energy and protein intake in percentage of estimated requrements'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Through study completion, an average of 5 days', 'description': 'Number of days from admission date at the pulmonary ward to discharge.'}, {'measure': 'Readmission', 'timeFrame': 'Measured at day 30', 'description': 'Number of participants that have been readmitted after discharge'}, {'measure': '30-days mortality', 'timeFrame': 'Measured at day 30', 'description': 'Measured as vital status at follow-up'}, {'measure': "Patients' experience of whether they received nutritional guidance during hospitalisation", 'timeFrame': 'Measured at day of discharge, on average day 5', 'description': 'The degree to which patients experience to have received nutritional guidance measured on 5-point Likert scales (5 indicating very high degree, 1 indicating very low degree)'}]}, 'conditionsModule': {'conditions': ['Pulmonary Diseases', 'Malnutrition']}, 'descriptionModule': {'briefSummary': "The study investigates whether clinical dietitians at a hospital ward can improve patients' dietary intake during hospitalisation, and whether it can prevent patients from being admitted efter discharge and improve their prognosis. Dietary intake will be measured daily and readmittance within 30 days from discharge will be registered. Questionnaires will be used to assess patients' satisfaction with nutritional care during hospitalisation.", 'detailedDescription': "Clinical dietitians have been an integrated part of the medical pulmonary ward at Gødstrup Hospital since early 2022. They carry out nutritional screening, nutritional treatment and assisst and guide patients in ordering of meals from the hospital's flexible á la carte food service concept.\n\nThe study aims to evaluate the effect of the clinical dietitians' effort on patients nutritional intake, risk of readmittance after discharge and 30-days mortality.\n\nThe study is observational, and no changes to the current standard of nutritional care will be implemented throughout the study period. Nutritional intake will be measured daily throughout hospitalisation. Readmittances and vital status will be measured at day 30.\n\nTo evaluate the effect of the dietitians' effort, data will be compared to historical data from a previous completed study at the same ward.\n\nPatient satisfaction with nutrional care during hospitalisation will be measured with a purpose-designed questionnaire.\n\nInformed written consent will be obtained from all patients before inclusion, and they will be informed that their partitipation is voluntary and that they can withdraw their consent at anytime."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at nutritional risk admitted to the pulmonary medical ward at Gødstrup Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly admitted at the medical pulmonary ward\n* Expected admittance of minimum 48 hours\n* At nutritional risk defined as a Nutritional Risk Screening 2002 Score of \\>=3\n* Able to understand and speak Danish\n\nExclusion Criteria:\n\n* Terminal illness\n* Dementia\n* Enteral or parenteral nutrition\n* Need of texture-modified diet or other special diets'}, 'identificationModule': {'nctId': 'NCT07234669', 'briefTitle': 'Dietitian-supported Meal-ordering and Systematic Nutritional Care', 'organization': {'class': 'OTHER', 'fullName': 'Gødstrup Hospital'}, 'officialTitle': 'Dietitian-supported Meal-ordering and Systematic Nutritional Care', 'orgStudyIdInfo': {'id': '2023-01'}}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Gødstrup Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Marianne B Kristensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gødstrup Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gødstrup Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}