Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-29 @ 10:50 PM
Study NCT ID:
NCT03412695
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2018-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight (kg) during hospital stay', 'timeFrame': '2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)', 'description': 'Measured standing on an electronic scale'}], 'secondaryOutcomes': [{'measure': 'Patient length of hospital stay', 'timeFrame': 'At the day of patient discharge (on day 11)', 'description': 'Length of hospital stay (LOS) will be measured for all participating patients. Average LOS in the intervention group will be compared with the average LOS in the control group'}, {'measure': 'Change in body Composition', 'timeFrame': '2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)', 'description': 'Fat free mass, muscle mass, fat mass, and phase angle. Measured by bioelectrical impedance analysis.'}, {'measure': 'Proportion of patients who receives a nutrition diagnose', 'timeFrame': "Assessed from medical journals every second day during each patient's hospital stay (11 days on average)", 'description': 'Number of patients who receives a nutrition diagnose (E46.00) will be measured among patients participating in the study. Proportion of patients who receives a nutrition diagnose in the intervention group will be compared with the proportion of patients who receives a nutrition diagnose in the control group.'}, {'measure': 'Proportion of patients who get implemented nutrition-related measures', 'timeFrame': "Assessed from medical journals every second day during each patient's hospital stay (11 days on average)", 'description': 'The decision support system gives recommendations for nutritional-related measures, based on individual symptoms and dietary intake compared to needs.'}, {'measure': 'Proportion of patients who receive a nutrition plan', 'timeFrame': "Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average)", 'description': 'According to the national guidelines all patients at nutritional risk should have an individual nutrition plan. The decision support system will generate a suggested nutrition plan, based on information recorded in the system. Proportion of patients in the intervention group who receives a nutrition plan, compared to proportion in the control group will be measured'}, {'measure': 'Re-admissions', 'timeFrame': '30 days after discharge', 'description': 'Unplanned re-admissions'}, {'measure': 'Patient generated subjective global assessment (PG-SGA) score', 'timeFrame': 'Measured on day 1 and at admission (day 11 on average)', 'description': 'The patient generated subjective global assessment (PG-SGA) is a form including questions on weight development, food intake, symptoms, and activity level and function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disease-related malnutrition', 'eHealth', 'Decision support system', 'Clinical nutrition'], 'conditions': ['Malnutrition']}, 'referencesModule': {'references': [{'pmid': '33766017', 'type': 'DERIVED', 'citation': 'Paulsen MM, Varsi C, Andersen LF. Process evaluation of the implementation of a decision support system to prevent and treat disease-related malnutrition in a hospital setting. BMC Health Serv Res. 2021 Mar 25;21(1):281. doi: 10.1186/s12913-021-06236-3.'}, {'pmid': '32241711', 'type': 'DERIVED', 'citation': "Paulsen MM, Paur I, Gjestland J, Henriksen C, Varsi C, Tangvik RJ, Andersen LF. Effects of using the MyFood decision support system on hospitalized patients' nutritional status and treatment: A randomized controlled trial. Clin Nutr. 2020 Dec;39(12):3607-3617. doi: 10.1016/j.clnu.2020.03.012. Epub 2020 Mar 19."}]}, 'descriptionModule': {'briefSummary': 'The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There is a lack of tools to follow up the nutritional treatment of these patients. The investigators develop the decision support system "MyFood" which can be used to assess patients\' dietary intake, evaluate intake against individual needs, and propose nutrition related measures and an individual nutrition plan for each patient. The investigators will study the clinical effects of using MyFood among hospitalized patients. In addition the implementation of the tool among healthcare workers will be studied.', 'detailedDescription': 'The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. Disease-related malnutrition increase the morbidity and mortality among patients and leads to longer length of stay. There is a lack of tools to follow up the nutritional treatment of patients at nutritional risk. The decision support system "MyFood" is developed in the project with the purpose to prevent and treat disease-related malnutrition. MyFood includes 4 modules: 1) A function to register patient needs and symptoms, 2) Dietary assessment function, 3) Automatic evaluation of dietary intake compared to individual needs, 4) Feedback, including a report on intake of energy, protein, and liquids compared to individual needs, and recommendations for nutritional measures and an individual nutrition plan.\n\nClinical effects of using MyFood among hospitalized patients will be studied in a randomized controlled trial. In addition, the implementation of the tool among nurses and other healthcare workers will be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* \\<72 hours expected hospital stay\n* Terminal patients\n* Pregnant\n* Psychiatric patients\n* Patients who cannot read the Norwegian Language\n* Patients diagnosed with: sickle cell anemia, haemophilia, or deep vein thrombosis'}, 'identificationModule': {'nctId': 'NCT03412695', 'briefTitle': 'Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition', 'orgStudyIdInfo': {'id': '2016/1464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Use of the MyFood tool among patients and nurses (intervention group)', 'interventionNames': ['Device: MyFood']}, {'type': 'NO_INTERVENTION', 'label': 'Arm B', 'description': 'No intervention. Regular hospital routines'}], 'interventions': [{'name': 'MyFood', 'type': 'DEVICE', 'description': 'Patients included in the intervention group will use the MyFood app to record their dietary intake. Nurses will use the report and recommendations in the MyFood tool to follow up the nutritional treatment of the patients.', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0372', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo university hospital, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project coordinator', 'investigatorFullName': 'Mari Mohn Paulsen', 'investigatorAffiliation': 'Oslo University Hospital'}}}}