Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-04 @ 10:09 AM
Study NCT ID:
NCT02138968
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2014-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Economic Assessment of a Pre-frail Screening Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2014-05-12', 'studyFirstSubmitQcDate': '2014-05-14', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain according Visual Analog Scale.', 'timeFrame': 'One year'}], 'primaryOutcomes': [{'measure': 'Frailty according to L.Fried criteria (questionnaire).', 'timeFrame': 'One year', 'description': 'L.Fried frailty criteria: (Robust: 0 criteria; Pre-frail: 1-2 criteria; Frail: \\>=3 criteria)\n\n1. Weight loss\n2. Fatigue\n3. Poor physical activity\n4. Low walking speed\n5. Low muscle strength Reference of L.Fried: J Gerontol A Biol Sci Med Sci. 2001 Mar; 56(3):M146-56. PMID: 11253156.'}, {'measure': 'Functional capacity according to Barthel score and Timed up and go test.', 'timeFrame': 'One year', 'description': 'Barthel score and Timed up and go test.'}], 'secondaryOutcomes': [{'measure': 'Nutritional status according to MNA-sf.', 'timeFrame': 'One year', 'description': 'Mini Nutritional Assessment short form (MNA-sf).'}, {'measure': 'Quality of live according to EuroQoL.', 'timeFrame': 'One year', 'description': 'EuroQoL.'}, {'measure': 'Mortality', 'timeFrame': 'One year'}, {'measure': 'Health resource consumption (composite measure)', 'timeFrame': 'One year', 'description': 'Number of visits to primary care center, number of visits to hospital emergency department, number of hospitalizations, days of hospital stay, institutionalization to nursing homes, visits to nutritionist and visits to social services.'}]}, 'conditionsModule': {'keywords': ['Pre-frailty', 'Frail', 'Exercise', 'Nutritional assessment', 'Functional capacity'], 'conditions': ['Pre-frail', 'Elderly']}, 'referencesModule': {'references': [{'pmid': '28064172', 'type': 'DERIVED', 'citation': 'Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, Palomera E, Tarradelles M, Papiol M. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017 May 1;46(3):401-407. doi: 10.1093/ageing/afw242.'}]}, 'descriptionModule': {'briefSummary': 'The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 70 years consulting in primary care\n* Non institutionalized\n* Pre-frailty according to L.Fried criteria (1 or 2 criteria)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patient not able to stand by himself/herself\n* Dementia\n* Palliative care or life expectancy less than 6 months\n* Blind patient\n* unstable clinical situation\n* Participation in other programs, studies or trials for elderly people'}, 'identificationModule': {'nctId': 'NCT02138968', 'briefTitle': 'Clinical and Economic Assessment of a Pre-frail Screening Program', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari del Maresme'}, 'officialTitle': 'Clinical and Economic Assessment of an Opportunistic Screening Program for Pre-frailty State in Elderly Population.', 'orgStudyIdInfo': {'id': '17/13'}, 'secondaryIdInfos': [{'id': 'CEIC 17/13', 'type': 'OTHER', 'domain': 'CEIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multidimensional intervention', 'description': 'Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.', 'interventionNames': ['Other: Multidisciplinary intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care'}], 'interventions': [{'name': 'Multidisciplinary intervention', 'type': 'OTHER', 'description': 'Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.', 'armGroupLabels': ['Multidimensional intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari del Maresme', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}], 'overallOfficials': [{'name': 'Mateu Serra-Prat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundació Salut del Consorci Sanitari del Maresme'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari del Maresme', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}