- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326556
Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People (RIEHO-C)
March 25, 2020 updated by: Virginia BRANCO
Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People, With Sensor-based Measurements of the Peri-individual Environment: a Prospective Cohort
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
80 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prospective cohort for etiological and prognostic purposes
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To describe the quality of the peri-individual atmospheric environment, both indoor and outdoor
Time Frame: 3 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2020
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
September 1, 2021
Study Registration Dates
First Submitted
March 25, 2020
First Submitted That Met QC Criteria
March 25, 2020
First Posted (Actual)
March 30, 2020
Study Record Updates
Last Update Posted (Actual)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- ACE ICSEN 17PIA725
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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