Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-28 @ 10:16 PM
Study NCT ID:
NCT01861366
Status:
COMPLETED
Last Update Posted:
2013-05-23
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Nutritional Guidelines and Effects in Nursing Home Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-22', 'studyFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biochemical markers', 'timeFrame': '2 years', 'description': 'Blood samples are collected for analysis of vitamin D, albumin, CRP (C-reactive protein), insulin-like growth factor 1 (IGF-1), creatinine and cystatin C, which gives biochemical information on the nutritional status, inflammation activity and renal function.'}, {'measure': 'Morbidity', 'timeFrame': '2 years', 'description': 'Morbidity is assessed with Charlson Comorbidity Index (CCI).'}], 'primaryOutcomes': [{'measure': 'Nutritional status', 'timeFrame': '2 years', 'description': 'Nutritional status is assessed with the Mini Nutritional Assessment-Short Form tool'}], 'secondaryOutcomes': [{'measure': 'Functional status', 'timeFrame': '2 years', 'description': 'Functional status is assessed with ADL (Activities in Daily Living) Barthel index.'}, {'measure': 'Cognitive status', 'timeFrame': '2 years', 'description': 'Cognitive status is assessed with Short Portable Mental Status Questionnaire (SPMSQ).'}, {'measure': 'Health-related Quality of Life', 'timeFrame': '2 years', 'description': 'Health-related Quality of Life is assessed with EQ-5D.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Implementation', 'Guidelines', 'Nutrition', 'Nursing home'], 'conditions': ['Implementation Strategies', 'Nutritional Outcome of Nursing Home Residents']}, 'referencesModule': {'references': [{'pmid': '25560819', 'type': 'DERIVED', 'citation': 'Torma J, Winblad U, Saletti A, Cederholm T. Strategies to implement community guidelines on nutrition and their long-term clinical effects in nursing home residents. J Nutr Health Aging. 2015 Jan;19(1):70-6. doi: 10.1007/s12603-014-0522-4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine two implementation strategies (external facilitation and educational outreach visit) when introducing nutritional guidelines in the elderly care setting and to evaluate the results of the implementation by clinical outcome measures of the nursing home residents.\n\nThe hypothesis is that the residents affected by the external facilitation strategy will stay stable in the measured clinical outcomes, while the residents influenced by the educational outreach visit will deteriorate during the implementation process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of 65 or older\n* nursing home resident\n* persons who manage the examination methods (interviews and blood samples)\n\nExclusion Criteria:\n\n\\- persons in terminal stage of life'}, 'identificationModule': {'nctId': 'NCT01861366', 'briefTitle': 'Implementation of Nutritional Guidelines and Effects in Nursing Home Residents', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Clinical Outcome in Nursing Home Residents After Implementation of Nutritional Guidelines', 'orgStudyIdInfo': {'id': 'MuMs07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External facilitator', 'description': 'The external facilitation is a one year multifaceted intervention, including support, guidance, practice audit and feedback, training targeted to a team of practitioners involving the unit manager, the nurses and diet aides at the nursing home. The facilitator is a researcher and dietician.', 'interventionNames': ['Other: A one year multifaceted implementation strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational outreach visit', 'description': 'The outreach visit is a three hour lecture about the nutritional guidelines targeted to a team of practitioners including the unit manager, the nurses and diet aides at the nursing home. The trained person giving the lecture is a researcher and dietician.', 'interventionNames': ['Other: A three hour lecture about the guidelines']}], 'interventions': [{'name': 'A one year multifaceted implementation strategy', 'type': 'OTHER', 'armGroupLabels': ['External facilitator']}, {'name': 'A three hour lecture about the guidelines', 'type': 'OTHER', 'armGroupLabels': ['Educational outreach visit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'state': 'Uppsala County', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Tommy Cederholm, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}