Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People

NCT04326556 | Unknown

• 1 other identifier: ACE ICSEN 17PIA725
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Environmental Exposure; Individual Difference

Outcome Measures

Primary Outcomes (1)

• To describe the quality of the peri-individual atmospheric environment, both indoor and outdoor

  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).

  3 years

Study Arms (1)

Prospective cohort for etiological and prognostic purposes

EXPERIMENTAL

Other: Prospective cohort for etiological and prognostic purposes

Interventions

Prospective cohort for etiological and prognostic purposes OTHER

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.

Prospective cohort for etiological and prognostic purposes

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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,
• Living at home or in a residence,
• Subject living in Ile-de-France,
• Subject speaking French; this study requires minimal participation of subjects (wearing sensors, qualitative interview) that does not appear compatible with comprehension problems,
• MMSE Score ≥ 15
• ADL score ≥ 3
• Affiliated with a health insurance plan or eligible,
• Person who has signed an informed and written consent.

You may not qualify if:

• Subject whose state of health requires hospitalization within two weeks,
• Subject under guardianship or curatorship,
• Subject living in collective housing (retirement home) or entering an institution within 2 weeks,
• Abundant thoracic hair causing poor contact of the ECG electrodes of the physiological sensor,
• 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,
• Subject already included in the study.

Sponsors & Collaborators

• Virginia BRANCO: lead

Central Study Contacts

Philippe AEGERTER, PhD

CONTACT

01 49 09 56 68; philippe.aegerter@uvsq.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of value creation

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 30, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 30, 2020

Record last verified: 2020-03