AgeingRIEHONCT00986739
Individual and Environmental Risk Factors of Unplanned Admissions of Elderly
An observational study of Ageing, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Ageing
- How many people
- 973 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2009to Jul 2017
- Phase
- Observational
- 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
Study population: Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward
Who may be able to join
- Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward.
- Three hospitals, two located in the Paris area and one in Champagne, offering emergency care and providing geriatric services will be involved in the study.
Who cannot join
- Refusal of the patient or of helping him to sign informed consent
- Refusal of the patient or of helping him to answer
- Premature exit before initial examination
Trial locations and contacts
2 sites in 1 country.
France2 sites
hopital Ambroise Paré
Boulogne-Billancourt, 92100
Service de Court Séjour Gériatrique, CHU DE REIMS, HOPITAL MAISON-BLANCHE
Reims, 51092
About this study
Official title: Individual and Environmental Risk Factors of Unplanned Admissions of Elderly : RIEHO Inception Cohort
The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution.
Read the detailed description
Background: Chronic diseases failed concerned people, notably elderly which accumulate them. Failure of failed organ in oldest old citizens (80 and over) often leads to unplanned hospitalization which may have dreadful consequences, such as worsening condition or even death. Few studies have sought to identify all individual and environmental risk factors for unplanned hospitalization of elderly citizens. The development of a nation-wide shared medical record would allow to build an alert system if such factors can be modelled.
Objective: The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution. Classifying at risk patients might help preventing unplanned hospitalization of oldest old. Correlations between medical data and the atmospheric pollution modelling will allow us to enhance the forecast system with dose-effect functions. Validation of a multi dimensional standardised instrument (InterRAI-MDS) will help in the development of a shared medical record.
Methods : Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward. Three hospitals, two located in the Paris area and one in Champagne, offering emergency care and providing geriatric services will be involved in the study. 1,200 patients will be prospectively included in the study during a one-year period.
- Individual study Data collection involves three steps (before, during and after health event) from hospital admission (i.e. study inclusion) and relies on a multi dimensional standardized geriatric assessment using well established scales : Retrospective data collection includes medical history, health care utilization, SOCIO-economic status and functional status the days before hospital admission ; Data collection at hospital admission includes functional, mental, nutritional and depression status assessed by geriatric physician and nurse (standardized geriatric assessment) ; social support and care plan will be recorded at discharge ; SOCIO-economic conditions will also be recorded Data collection during follow-up includes health and functional status assessed at three, six, nine months and one year after first emergency visit, with help of the family and family physician. Hospitalizations and death will be recorded.
- Environmental and contextual data Meteorological data as well as data on pollution, epidemics, strikes in health care system or public transportation and public holiday will be gathered during the study period. The use of the atmospheric transport chemistry model CHIMERE will give greater spatial (2 to 3 km) and temporal (hour) resolution than airborne measurements of pollutants.
- Analysis A bidirectional case-crossover design will be used. Cases serve as their own controls through the use of information on the study subjects both before and after the event (hospitalization). Conditional logistic regression will then be used to investigate the short-term health effects of air pollution while taking into account individual characteristics.
Survival analysis with time dependant covariates (environmental factors) will give strengthening results.
A multi dimensional analysis will be performed to determine cluster of patients and patterns of environmental parameters.
Validation of the RAI-MDS instrument will rely on internal coherency, structural validity and external validity facing usual geriatric scales (ADL, IADL, MMSE, MNA, GDS).
Perspectives Identification of individual risk factors as well as evaluation of environmental threat for older people, potentialized by the setting of medical shared across caregivers could allow to develop individualized alarm and prevention systems.
- Conditions
- Ageing
- Keywords
- Chronic pathologies, elderly, atmospheric pollution, unplanned hospitalization, case-crossover
What is being measured
The primary outcome is the main question the study is designed to answer.
Factor to explain is unplanned hospitalizations, it will also look into the institution or death, the factors are individual characteristics (medical, functional) and environmental (family, social, physical)
Measured: 3 years
Secondary outcomes (5)
Typology of elderly people
Measured: 3 years
Types of weather patterns and environmental
Measured: 3 years
Modeling of pollution levels and a dose-response relationship
Measured: 3 years
Validity of questionnaire RAI (Resident Assessment Instrument): reproducibility, internal consistency, validity of structure and against criterion
Measured: 3 years
Appropriateness of hospital admissions
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 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Aegerter, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986739
- Sponsor's protocol ID
- AOM 08205
- Acronym
- RIEHO
- Status last verified
- Oct 2016
- First submitted
- 29 Sep 2009
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual and Environmental Risk Factors of Unplanned Admissions of Elderly : RIEHO Inception Cohort
- ClinicalTrials.gov ID
- NCT00986739
- Acronym / sponsor ID
- RIEHO / AOM 08205
- Conditions
- Ageing
- Keywords
- Chronic pathologies, elderly, atmospheric pollution, unplanned hospitalization, case-crossover
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 973 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 30 Sep 2009 (estimated)
- 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 aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution.
Detailed description
Background: Chronic diseases failed concerned people, notably elderly which accumulate them. Failure of failed organ in oldest old citizens (80 and over) often leads to unplanned hospitalization which may have dreadful consequences, such as worsening condition or even death. Few studies have sought to identify all individual and environmental risk factors for unplanned hospitalization of elderly citizens. The development of a nation-wide shared medical record would allow to build an alert system if such factors can be modelled.
Objective: The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution. Classifying at risk patients might help preventing unplanned hospitalization of oldest old. Correlations between medical data and the atmospheric pollution modelling will allow us to enhance the forecast system with dose-effect functions. Validation of a multi dimensional standardised instrument (InterRAI-MDS) will help in the development of a shared medical record.
Methods : Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward. Three hospitals, two located in the Paris area and one in Champagne, offering emergency care and providing geriatric services will be involved in the study. 1,200 patients will be prospectively included in the study during a one-year period.
- Individual study Data collection involves three steps (before, during and after health event) from hospital admission (i.e. study inclusion) and relies on a multi dimensional standardized geriatric assessment using well established scales : Retrospective data collection includes medical history, health care utilization, SOCIO-economic status and functional status the days before hospital admission ; Data collection at hospital admission includes functional, mental, nutritional and depression status assessed by geriatric physician and nurse (standardized geriatric assessment) ; social support and care plan will be recorded at discharge ; SOCIO-economic conditions will also be recorded Data collection during follow-up includes health and functional status assessed at three, six, nine months and one year after first emergency visit, with help of the family and family physician. Hospitalizations and death will be recorded.
- Environmental and contextual data Meteorological data as well as data on pollution, epidemics, strikes in health care system or public transportation and public holiday will be gathered during the study period. The use of the atmospheric transport chemistry model CHIMERE will give greater spatial (2 to 3 km) and temporal (hour) resolution than airborne measurements of pollutants.
- Analysis A bidirectional case-crossover design will be used. Cases serve as their own controls through the use of information on the study subjects both before and after the event (hospitalization). Conditional logistic regression will then be used to investigate the short-term health effects of air pollution while taking into account individual characteristics.
Survival analysis with time dependant covariates (environmental factors) will give strengthening results.
A multi dimensional analysis will be performed to determine cluster of patients and patterns of environmental parameters.
Validation of the RAI-MDS instrument will rely on internal coherency, structural validity and external validity facing usual geriatric scales (ADL, IADL, MMSE, MNA, GDS).
Perspectives Identification of individual risk factors as well as evaluation of environmental threat for older people, potentialized by the setting of medical shared across caregivers could allow to develop individualized alarm and prevention systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward
Key inclusion criteria (2 listed)
- Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward.
- Three hospitals, two located in the Paris area and one in Champagne, offering emergency care and providing geriatric services will be involved in the study.
Key exclusion criteria (3 listed)
- Refusal of the patient or of helping him to sign informed consent
- Refusal of the patient or of helping him to answer
- Premature exit before initial examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factor to explain is unplanned hospitalizations, it will also look into the institution or death, the factors are individual characteristics (medical, functional) and environmental (family, social, physical)
Time frame: 3 years
5 secondary outcomes
Typology of elderly people
Time frame: 3 years
Types of weather patterns and environmental
Time frame: 3 years
Modeling of pollution levels and a dose-response relationship
Time frame: 3 years
Validity of questionnaire RAI (Resident Assessment Instrument): reproducibility, internal consistency, validity of structure and against criterion
Time frame: 3 years
Appropriateness of hospital admissions
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
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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.
Philippe Aegerter, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ageing, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factor to explain is unplanned hospitalizations, it will also look into the institution or death, the factors are individual characteristics (medical, functional) and environmental (family, social, physical) (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 12 Sep 2017.