Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-01 @ 12:54 PM
Study NCT ID:
NCT01141166
Status:
UNKNOWN
Last Update Posted:
2010-06-10
First Post:
2010-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Octabaix Intervention Study
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 328}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'lastUpdateSubmitDate': '2010-06-09', 'studyFirstSubmitDate': '2010-04-14', 'studyFirstSubmitQcDate': '2010-06-09', 'lastUpdatePostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of falls and rate of undernutrition risk as MNA < 23,5', 'description': 'Nutritional risk was evaluated by the MNA questionnaire'}], 'secondaryOutcomes': [{'measure': 'Different geriatrics characteristics', 'description': 'Functional, cognitive and nutritional status and social risk were assessed by instruments currently used in geriatric practice. Functional status was measured using the BI (Mahoney and Barthel, 1965) for the basic ADL, and the Lawton index (LI) (Lawton and Brody, 1969). Cognitive function was measured by the Spanish version (MEC) (Lobo et al., 1999) of the MMSE. Comorbidity by the Charlson comorbidity index (CCI)and the others.'}]}, 'conditionsModule': {'keywords': ['ELDERLY', 'NUTRITION'], 'conditions': ['Falls', 'Malnutrition']}, 'referencesModule': {'references': [{'pmid': '25887312', 'type': 'DERIVED', 'citation': 'Badia T, Formiga F, Ferrer A, Sanz H, Hurtos L, Pujol R. Multifactorial assessment and targeted intervention in nutritional status among the older adults: a randomized controlled trial: the Octabaix study. BMC Geriatr. 2015 Apr 11;15:45. doi: 10.1186/s12877-015-0033-0.'}, {'pmid': '24596458', 'type': 'DERIVED', 'citation': 'Ferrer A, Formiga F, Sanz H, de Vries OJ, Badia T, Pujol R; OCTABAIX Study Group. Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial. Clin Interv Aging. 2014 Feb 25;9:383-93. doi: 10.2147/CIA.S57580. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.', 'detailedDescription': 'Design: Randomized, controlled trial.\n\nMethod: Three hundred and twenty eight people born in 1924, after recruitment will be followed for a three year period. Subjects received two in-home visits from a trained nurse or physicians who assessed falls and nutritional risk factors using an algorithm.\n\nThe intervention consisted of recommendations to the subject and their primary physician, and other providers, telephone calls, and exercise and nutritional plan. Control subjects received a general primary care assessment.\n\nMeasurements: the primary outcome were rate of falls and rate of undernourished risk. Secondary outcomes included different geriatrics characteristics.The outcomes of this study will provide important new information to reduce the incidence of falls and the risk of undernutrition of this population by intervention. Significant differences are not expected according to social-demographics sex and other factors, but they are expected by other obtained factors and indices that could allow to detection of octogenarian people with great risk of deterioration in just a short time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '85 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized\n\nExclusion Criteria:\n\n* Institutionalized'}, 'identificationModule': {'nctId': 'NCT01141166', 'briefTitle': 'Octabaix Intervention Study', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects', 'orgStudyIdInfo': {'id': 'AFF2191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nutritional and physical rehabilitation plan', 'interventionNames': ['Behavioral: nutritional and a rehabilitation plan.']}], 'interventions': [{'name': 'nutritional and a rehabilitation plan.', 'type': 'BEHAVIORAL', 'description': 'The intervention consisted of recommendations to the subject and their primary physician, and others providers, telephone calls of a nutritional and a rehabilitation plan.', 'armGroupLabels': ['nutritional and physical rehabilitation plan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08980', 'city': 'Sant Feliu de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Assumpta Ferrer Feliu', 'geoPoint': {'lat': 41.38333, 'lon': 2.05}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': 'Preventive Services and Health Promotion Research Network', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Cecíla Borau', 'oldOrganization': 'Jordi Gol i Gurina Foundation'}}}}