Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 2:13 AM
Study NCT ID:
NCT01449968
Status:
COMPLETED
Last Update Posted:
2014-04-28
First Post:
2011-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Provision of a Mobile Geriatric Team Extra-Community Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006792', 'term': 'House Calls'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-25', 'studyFirstSubmitDate': '2011-07-07', 'studyFirstSubmitQcDate': '2011-10-07', 'lastUpdatePostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effectiveness of the visit of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month', 'timeFrame': '1 month', 'description': 'inappropriate survival without hospitalization through the emergency room at 1 month'}], 'secondaryOutcomes': [{'measure': 'follow-up rate of the proposals of UMG ext (adherence to recommendations and feasibility) and analyze the reasons for not monitoring these proposals one month', 'timeFrame': '1 month', 'description': 'follow-up of recommendations made by the mobile unit of Geriatrics'}, {'measure': 'survival without hospitalization inappropriate, mortality, changes in functional status and cognitive health care consumption up to 6 months of surgery', 'timeFrame': '6 months', 'description': 'Unplanned hospitalization rates obtained by telephone follow-up at 3 and 6 months'}, {'measure': 'effectiveness of the visit of the mobile geriatric home versus telephone follow-up of mobile geriatric unit', 'timeFrame': '6 months', 'description': 'Analysis of sub-groups'}, {'measure': 'needs and difficulties of attending physicians in the care of frail elderly patients with complex medical and social situation before and after the establishment of mobile units for geriatrics.', 'timeFrame': '1 year', 'description': 'Questionnaire to GPs in the health sector concerned'}, {'measure': 'cost effectiveness of two types of visit of the mobile unit of Geriatrics (telephone regulation and control over travel home phone)', 'timeFrame': '6 months', 'description': 'Cost of hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Geriatric Disorder', 'Mobil Unit']}, 'referencesModule': {'references': [{'pmid': '9563983', 'type': 'BACKGROUND', 'citation': 'Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, Rubenstein LZ, Carbonin P. Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ. 1998 May 2;316(7141):1348-51. doi: 10.1136/bmj.316.7141.1348.'}, {'pmid': '8105269', 'type': 'BACKGROUND', 'citation': 'Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6. doi: 10.1016/0140-6736(93)92884-v.'}, {'pmid': '11576978', 'type': 'BACKGROUND', 'citation': 'Elkan R, Kendrick D, Dewey M, Hewitt M, Robinson J, Blair M, Williams D, Brummell K. Effectiveness of home based support for older people: systematic review and meta-analysis. BMJ. 2001 Sep 29;323(7315):719-25. doi: 10.1136/bmj.323.7315.719.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month.\n\nThe primary endpoint: survival without hospitalization through the emergency inappropriate to 1 month.', 'detailedDescription': 'The purpose of this study is to assess the effectiveness of the Mobile Geriatrics on the management of complex situations in retirement homes and in ambulatory care of frail elderly patients, reported by the generalist doctor, in terms of improving the conditions of use technical support hospital follow-up recommendations given by the mobile team and their impact on outcomes of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes patients over 75 years in medical condition or psycho-social complex, followed by a general practitioner to population centers include: Grenoble, Annecy and Roanne.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 75 and over living in complex medical or psycho-social complex or at risk of hospitalization\n* Patient affiliated to social security or beneficiary of such a regime\n* Patient available for follow-up to 6 months with a caregiver or accompanying social duly appointed.\n\nExclusion Criteria:\n\n* Patient residing outside intervention sector\n* Life-threatening emergency (ambulance)\n* Lack of complexity of the situation, supported by routine care'}, 'identificationModule': {'nctId': 'NCT01449968', 'acronym': 'UMG', 'briefTitle': 'Provision of a Mobile Geriatric Team Extra-Community Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Provision of a Mobile Geriatric Team Extra-Community Hospital in Assessing and Regulating the Hospitalization of Frail Elderly Patients With Complex Medical and Social Situation', 'orgStudyIdInfo': {'id': 'DCIC 10 16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'home visit of UMG', 'description': 'home visit with evaluation and management of the situation (control over in-home telephone)', 'interventionNames': ['Other: home visit']}, {'label': 'telephone management', 'description': 'geriatric mobile unit provides a telephone advice only to the general practitioner with guidance and recommendations (call control)', 'interventionNames': ['Other: telephone management']}], 'interventions': [{'name': 'home visit', 'type': 'OTHER', 'description': 'home visit of UMG', 'armGroupLabels': ['home visit of UMG']}, {'name': 'telephone management', 'type': 'OTHER', 'otherNames': ['telephone management of the mobile unit of Geriatrics'], 'description': "telephone management of the situation reported by the patient's GP", 'armGroupLabels': ['telephone management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74000', 'city': 'Annecy', 'country': 'France', 'facility': 'CH Annecy', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital of Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '42300', 'city': 'Roanne', 'country': 'France', 'facility': 'CH Roanne', 'geoPoint': {'lat': 46.03624, 'lon': 4.06802}}], 'overallOfficials': [{'name': 'Pascal COUTURIER, PUPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geriatric unit - University Hospital of Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pr Pascal COUTURIER, University Hospital, Grenoble', 'investigatorFullName': 'AdministrateurCIC', 'investigatorAffiliation': 'University Hospital, Grenoble'}}}}