Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT03131856
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2017-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Intervention in Geriatric 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible patients were randomized to either the intervention group or control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional status', 'timeFrame': 'Three months follow-up', 'description': 'Change in body weight (kg)'}], 'secondaryOutcomes': [{'measure': 'Functional status', 'timeFrame': 'Three months follow-up', 'description': 'Barthel Index (scale 0-100)'}, {'measure': 'Functional status', 'timeFrame': 'Three months follow-up', 'description': 'Handgrip strength (kg)'}, {'measure': 'Self-rated health', 'timeFrame': 'Three months follow-up', 'description': 'Self-rated health was measured with one single question with 5 possible responses on a Likert scale: In general, how would you rate your Health?'}, {'measure': 'Re-admission', 'timeFrame': 'Up to three months', 'description': 'All-cause unplanned readmissions'}, {'measure': 'Mortality', 'timeFrame': '1) Up to 90 days after discharge 2) Up to 120 days after discharge', 'description': 'All-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geriatrics', 'Nutritional risk', 'Multi-disciplinary intervention', 'Randomized Controlled Trial'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 or above\n* BMI \\<20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill\n\nExclusion Criteria:\n\n* Terminal illness\n* Active cancer diagnosis\n* Permanently living in a nursing home\n* Not willing or able to give an informed consent.'}, 'identificationModule': {'nctId': 'NCT03131856', 'briefTitle': 'Nutritional Intervention in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Geriatric-Project-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional intervention programme', 'description': 'An individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).', 'interventionNames': ['Behavioral: Nutritional intervention programme']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care which means no individual dietary plan and no nutrition follow-up visits after discharge.'}], 'interventions': [{'name': 'Nutritional intervention programme', 'type': 'BEHAVIORAL', 'description': 'The intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse.', 'armGroupLabels': ['Nutritional intervention programme']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigater', 'investigatorFullName': 'Rikke Terp', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}