Environmental ExposureRIEHO-CNCT04326556
Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People
A study testing Prospective cohort for etiological and prognostic purposes in people with Environmental Exposure and Individual Difference, run by Virginia BRANCO.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Environmental Exposure, Individual Difference
- What is being tested?
- Prospective cohort for etiological and prognostic purposes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Environmental Exposure, Individual Difference
- Being tested
- Prospective cohort for etiological and prognostic purposes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective cohort for etiological and prognostic purposesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort for etiological and prognostic purposes | Experimental | Not described Receives: Other: Prospective cohort for etiological and prognostic purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia BRANCO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Virginia BRANCO, University of Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326556
- Sponsor's protocol ID
- ACE ICSEN 17PIA725
- Acronym
- RIEHO-C
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People, With Sensor-based Measurements of the Peri-individual Environment: a Prospective Cohort
- ClinicalTrials.gov ID
- NCT04326556
- Acronym / sponsor ID
- RIEHO-C / ACE ICSEN 17PIA725
- Conditions
- Environmental Exposure, Individual Difference
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Virginia BRANCOUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort for etiological and prognostic purposes | Experimental | Other: Prospective cohort for etiological and prognostic purposes |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective cohort for etiological and prognostic purposesSubjects 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. | Other | Prospective cohort for etiological and prognostic purposes |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective cohort for etiological and prognostic purposes in people with Environmental Exposure and Individual Difference, run by Virginia BRANCO.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe AEGERTER, PhD (01 49 09 56 68, philippe.aegerter@uvsq.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the quality of the peri-individual atmospheric environment, both indoor and outdoor (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.