Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-28 @ 9:17 AM
Study NCT ID:
NCT01285869
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2011-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-24', 'studyFirstSubmitDate': '2011-01-27', 'studyFirstSubmitQcDate': '2011-01-27', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare resources utilization (readmissions and consultations to hospital and emergency department).', 'timeFrame': '1 year after hospital admission for pneumonia', 'description': 'To achieve the variables related to the healthcare resource utilization, computarized medical records will be reviewed and all patients will be followed up by telephone interview one year after discharge.The cause for readmission will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Functional status', 'timeFrame': '1 year after hospital admission for pneumonia', 'description': 'Data will be obtained by review of medical records and telephone interview one year after discharge.\n\nDependency in basic activities of daily living will be scored using the Barthel Index (Mahoney \\& Barthel. Maryland State Med J 14; 61-65) which measures the capacity to perform ten basic activities and gives a quantitative estimation of the patient level of dependency, scoring to 0 (totally dependent) to 100 (totally independent).'}, {'measure': 'Institutionalization', 'timeFrame': '1 year after hospital admission for pneumonia', 'description': 'Data will be obtained by review of medical records and telephone interview one year after discharge.'}, {'measure': 'Survival', 'timeFrame': '1 year after hospital admission for pneumonia', 'description': 'Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'Intervention Studies', 'Aged', 'Aged, 80 and over', 'Geriatric Assessment'], 'conditions': ['Community-acquired Pneumonia', 'Healthcare-associated Pneumonia']}, 'referencesModule': {'references': [{'pmid': '26526565', 'type': 'BACKGROUND', 'citation': 'Torres OH, Gil E, Comas MT, Saez ME, Clotet S, Ramirez HD, Mateo M, Ruiz D. [Impact of a multidimensional intervention in elderly patients with community-acquired pneumonia: IMIEPCAP clinical trial]. Rev Esp Geriatr Gerontol. 2016 Jan-Feb;51(1):37-43. doi: 10.1016/j.regg.2015.09.004. Epub 2015 Oct 30. Spanish.'}], 'seeAlsoLinks': [{'url': 'http://www.elsevier.es/es-revista-revista-espanola-geriatria-gerontologia-124-linkresolver-impacto-una-intervencion-multidimensional-pacientes-S0211139X15001808', 'label': 'Link to the article with description of the study is provided'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that long-term outcome in elderly patients admitted with the diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) would improve with a multidimensional intervention including assessment of co-morbidities, nutritional, functional and cognitive status and immunization.', 'detailedDescription': 'Detailed description published in "Revista Española de Geriatría y Gerontología" (see citation and link)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly patients (aged 65 years and over), of either sex, not dependent for basic activities of daily living (Barthel index ≥60 points).\n* Diagnosed with community-acquired pneumonia at the Emergency Department or Day Hospitals at "Hospital de la Santa Creu I Santa Pau"\n* Admitted to hospital.\n\nExclusion Criteria:\n\n* Derived from other acute care hospitals.\n* Patients with HIV infection.\n* Neutrophil counter\\<1000/mm3\n* Transplanted patients.\n* Barthel index\\<60 points.\n* Terminal disease.\n* No signed informed consent.'}, 'identificationModule': {'nctId': 'NCT01285869', 'acronym': 'IMIEPAP', 'briefTitle': 'Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia: a Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'IIBSP-INT-2010-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multidisciplinar intervention', 'description': 'Patients that will receive the multidimensional intervention during the ambulatory follow-up.', 'interventionNames': ['Other: Multidimensional intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional follow up', 'description': 'This is an observation only group and outpatient follow up will be indicated in accordance with usual and customary practices.'}], 'interventions': [{'name': 'Multidimensional intervention', 'type': 'OTHER', 'otherNames': ['Comprehensive geriatric assesment'], 'description': 'The patient will be cited 2 months after hospital discharge for a geriatric evaluation carried out by a geriatric nurse and an internist with geriatric training. The duration of the first visit is 45-60 minutes. The visit consists of: 1. Assessment of the pneumonia resolution, co-morbidities, aspiration risk, risk of multiresistant infections, and the immunization, functional and cognitive status. 2. An individualized intervention plan. The patient and family or caregiver will receive an educational intervention, a written report with the planned intervention and an educational leaflet. Those patients who require further assessment or follow up of the intervention will receive 1 or 2 more visits and all the patients will be cited one year after the first visit.', 'armGroupLabels': ['Multidisciplinar intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Olga H Torres, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, {'name': 'Domingo Ruiz, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}