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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in France

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.

  1. 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.
  2. 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.
  3. 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.

  1. 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)
  1. Typology of elderly people

    Measured: 3 years

  2. Types of weather patterns and environmental

    Measured: 3 years

  3. Modeling of pollution levels and a dose-response relationship

    Measured: 3 years

  4. Validity of questionnaire RAI (Resident Assessment Instrument): reproducibility, internal consistency, validity of structure and against criterion

    Measured: 3 years

  5. 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.

  1. First posted30 Sep 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

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)
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

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.

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