Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04326556
Status:
UNKNOWN
Last Update Posted:
2020-03-30
First Post:
2020-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2020-03-25', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the quality of the peri-individual atmospheric environment, both indoor and outdoor', 'timeFrame': '3 years', 'description': 'The quality of the peri-individual atmospheric environment will be described by the distribution (average, maximum and cumulative values) of the daily concentrations of pollutants (PM10, NO2).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Environmental Exposure', 'Individual Difference']}, 'descriptionModule': {'briefSummary': 'The elderly are weakened by the accumulation of chronic diseases. Their acute decompensation often leads to unscheduled hospitalization, which constitutes a breach of care with often serious consequences in terms of morbidity and mortality. Few studies have identified all the risk factors for unscheduled hospitalization in the very elderly. This project deals with the impact of air pollution on the very elderly as a source of physiological decompensations leading to unscheduled hospitalizations, in association with other individual and environmental risk factors. It complements the Rieho cohort that followed 973 elderly people on the same objective and enriches it with the use of sensors measuring the peri-individual atmospheric environment.', 'detailedDescription': 'In order to facilitate the perspective and scientific valorization of these data, the experimental design and population characteristics reproduce those of the RIEHO cohort (Coordinator P Aegerter), which aims to identify individual and environmental risk factors for unscheduled hospitalization of the elderly and included 973 people over 80 years of age with a 2-year follow-up, closed in early 2017. Indeed, the workforce mobilized in the Rieho-C study is undersized to measure an association between air quality and a major health impact (hospitalization or death), this objective can only be achieved by adding Rieho-C data to those of Rieho.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Person over 80 years of age consulting in the geriatrics department of Ste-Périne Hospital (Gerontology Consultations, Dr A Hiance- Delahaye, Head of Department Pr J Ankri. Paris XVI), for a standardised geriatric assessment, for any reason, if it does not result in immediate or foreseeable hospitalisation within 2 weeks,\n* Living at home or in a residence,\n* Subject living in Ile-de-France,\n* Subject speaking French; this study requires minimal participation of subjects (wearing sensors, qualitative interview) that does not appear compatible with comprehension problems,\n* MMSE Score ≥ 15\n* ADL score ≥ 3\n* Affiliated with a health insurance plan or eligible,\n* Person who has signed an informed and written consent.\n\nExclusion Criteria:\n\n* Subject whose state of health requires hospitalization within two weeks,\n* Subject under guardianship or curatorship,\n* Subject living in collective housing (retirement home) or entering an institution within 2 weeks,\n* Abundant thoracic hair causing poor contact of the ECG electrodes of the physiological sensor,\n* Rejection of patient's contact information, refuses to answer questionnaires and follow-up visits, or refuses to wear sensors, Impossibility, during the initial assessment, to establish at least telephone contact with the caregiver when he or she organizes the home visit,\n* Subject already included in the study."}, 'identificationModule': {'nctId': 'NCT04326556', 'acronym': 'RIEHO-C', 'briefTitle': 'Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'University of Versailles'}, 'officialTitle': 'Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People, With Sensor-based Measurements of the Peri-individual Environment: a Prospective Cohort', 'orgStudyIdInfo': {'id': 'ACE ICSEN 17PIA725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective cohort for etiological and prognostic purposes', 'interventionNames': ['Other: Prospective cohort for etiological and prognostic purposes']}], 'interventions': [{'name': 'Prospective cohort for etiological and prognostic purposes', 'type': 'OTHER', 'description': 'Subjects benefit from a standardized, comprehensive geriatric evaluation in accordance with the recommendations of good practice during a geriatric consultation. It is completed by a measurement of the gripping force using a dynamometer and a measurement of the respiratory parameters (vital capacity) using a spirometer. The following acts are added to the consultation: the completion of questionnaires, a semi-directed interview focused on the perception of air pollution, the wearing on the chest for one week of an individual mobile physiological signal sensor (DM with CE marking) and the wearing (on the belt or in a bag) for one week of a portable device with two air pollution sensors.', 'armGroupLabels': ['Prospective cohort for etiological and prognostic purposes']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Philippe AEGERTER, PhD', 'role': 'CONTACT', 'email': 'philippe.aegerter@uvsq.fr', 'phone': '01 49 09 56 68'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia BRANCO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'director of value creation', 'investigatorFullName': 'Virginia BRANCO', 'investigatorAffiliation': 'University of Versailles'}}}}