Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-02-27 @ 10:32 AM
Study NCT ID:
NCT02348892
Status:
UNKNOWN
Last Update Posted:
2015-01-28
First Post:
2015-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-22', 'studyFirstSubmitDate': '2015-01-16', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost-utility analysis (CUA)', 'timeFrame': '6 months', 'description': "A differential cost-utility ratio will be used to compare both interventions. The evaluation of costs will take into account direct health care insurance cost, hospital costs and patient cost (according to the french health care insurance system). The evaluation of utility will be based on the evaluation of patient's quality of life, measured by EuroQol EQ-5D."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Elderly Patients in Complex Situations']}, 'descriptionModule': {'briefSummary': 'The large share of chronic diseases correlated with an aging population calls to develop necessary coordination between the hospital and non-hospital (professional of the city, home ...) to create new complementarities.\n\nSince July 2013, the Nantes University Hospital experiences the establishment of a coordinator route patient in Gerontology. The evaluation program of the benefit of coordinating the course in elderly patients in health establishment (PROCOPES) must allow to prove the efficiency of the intervention of a coordinator route patient, following elderly patients in complex situations, both within the hospital and outside the hospital (home, nursing home,...). The objective of PROCOPES is to show the added value of an innovative position that can make the link between the hospital and the city on deemed complex situations.The pilot study results present a strong interest for health care settings, nursing home and in the world of research. It will also permit to have preliminary data for bigest studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The eligible patients for the study will be the patients of 70 and more years old hospitalized in the Nantes UH in the acute care medical department internal medical departement medical urgency, rehabilitation unit, neurology, gastro-enterology of the CHU of Nantes and which are in complex medical and social situation, whoever is their motive for hospitalization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of 70 and more years old\n* Patient living on Nantes\n* Hospitalized in Nantes UH\n* Patient whose the hospitalization is not relevant at the time of the request of trajectory case manager\n* Patient whose the situation is complex (without solution at the time of the request)\n* Patient (or legal representative) having given his assent of participation\n\nExclusion Criteria:\n\n* Patient (or legal representative) refusing to participate in the protocol\n* Patient whose follow-up is impossible (ex: programmed move, life expectation)'}, 'identificationModule': {'nctId': 'NCT02348892', 'acronym': 'PROCOPES', 'briefTitle': 'Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.', 'orgStudyIdInfo': {'id': 'RC14_0343'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With coordinator', 'description': 'Elderly patients, in complex situation, taken care by coordinator', 'interventionNames': ['Other: Coordinator']}, {'label': 'Without coordinator', 'description': 'Elderly patients, in complex situation, taken care by the classic plan', 'interventionNames': ['Other: Classic plan']}], 'interventions': [{'name': 'Coordinator', 'type': 'OTHER', 'description': 'Patients in complex situation taken care by coordinator', 'armGroupLabels': ['With coordinator']}, {'name': 'Classic plan', 'type': 'OTHER', 'description': 'Patients in complex situation taken care by classic plan', 'armGroupLabels': ['Without coordinator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles Berrut', 'role': 'CONTACT', 'email': 'gilles.berrut@chu-nantes.fr'}, {'name': 'Dibon Christelle', 'role': 'CONTACT', 'email': 'christelle.dibon@chu-nantes.fr'}], 'facility': 'Nantes UH', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}