Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-02 @ 1:21 PM
Study NCT ID:
NCT01873456
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064686', 'term': 'Nutritionists'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-06-06', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'up to 6 months', 'description': 'EuroQol (EQ-5D) is a questionnaire with five questions to be answered in three categories. The five questions deal of movement, self-care, usual activities, pain / discomfort and anxiety / depression and any problems with this'}], 'secondaryOutcomes': [{'measure': 'Nutritional status', 'timeFrame': 'up to 6 months', 'description': 'Assessment of weight'}, {'measure': 'Hand grip strength', 'timeFrame': 'up to 6 months', 'description': 'Residents and clients hand grip strength is determined using the dynamometer The dynamometer consists of a narrow handle with two strings as the older must squeezing so hard, they manage three times. The highest value will be used.'}, {'measure': 'Costs', 'timeFrame': 'up to 6 months', 'description': 'Here is used information on additional costs of nutrition efforts, which on the one hand involves all costs associated with the effort, while on the other hand also be seen on the savings that can be attached to the outcome of the effort. Since the purpose is to illustrate the cost-effectiveness, the net profit on the cost side is also compared with the effect of nutritional intervention in terms of improved quality of life, and hence would be able to shed light on efforts from both resource use and a health effect'}, {'measure': 'Activities of Daily Living and cognitive performance', 'timeFrame': 'up to 6 months', 'description': 'Data is collected by Means of the resident assessment instrument'}, {'measure': 'physical strength', 'timeFrame': 'up to 6 months', 'description': '30 seconds chair stand is used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Frail Older Adults']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Beck AM, Keiding H, Christensen AG, Hansen BS, Svendsen SD, et al. (2015) Multidisciplinary Nutritional Support for Page 2 of 7 Undernutrition in Older Adults in Nursing Home and Home-Care is Cost-Effective. SOJ Nur Health Care 1(1): 1-7.'}, {'pmid': '25163483', 'type': 'RESULT', 'citation': 'Beck AM, Gogsig Christensen A, Stenbaek Hansen B, Damsbo-Svendsen S, Kreinfeldt Skovgaard Moller T, Boll Hansen E, Keiding H. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial. Nutr J. 2014 Aug 28;13:86. doi: 10.1186/1475-2891-13-86.'}, {'pmid': '26553461', 'type': 'RESULT', 'citation': 'Beck AM, Christensen AG, Hansen BS, Damsbo-Svendsen S, Moller TK. Multidisciplinary nutritional support for undernutrition in nursing home and home-care: A cluster randomized controlled trial. Nutrition. 2016 Feb;32(2):199-205. doi: 10.1016/j.nut.2015.08.009. Epub 2015 Sep 3.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Screening for nutritional risk\n\nExclusion Criteria:\n\n* terminal condition or do not wish to participate'}, 'identificationModule': {'nctId': 'NCT01873456', 'acronym': 'CES', 'briefTitle': 'Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?', 'orgStudyIdInfo': {'id': 'CES1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multifactorial nutritional intervention', 'description': 'dietician, resistance type exercise, dysphagia assessment and treatment', 'interventionNames': ['Other: multifactorial nutritional intervention']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'usual care'}], 'interventions': [{'name': 'multifactorial nutritional intervention', 'type': 'OTHER', 'otherNames': ['dietician, resitance type exercise, dysphagia assessment and treatment'], 'armGroupLabels': ['Multifactorial nutritional intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Home care and nursing homes', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Anne Marie Beck', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reserarch Director', 'investigatorFullName': 'Christian Bitz', 'investigatorAffiliation': 'Copenhagen University Hospital at Herlev'}}}}