Individual and Environmental Risk Factors of Unplanned Admissions of Elderly (RIEHO)
| Tracking Information | |||||
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| First Received Date ICMJE | September 29, 2009 | ||||
| Last Updated Date | February 13, 2013 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00986739 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Individual and Environmental Risk Factors of Unplanned Admissions of Elderly | ||||
| Official Title ICMJE | Individual and Environmental Risk Factors of Unplanned Admissions of Elderly : RIEHO Inception Cohort | ||||
| Brief Summary | The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution. |
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| 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.
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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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 |
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| Condition ICMJE | Elderly Gravida | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1200 | ||||
| Estimated Completion Date | July 2013 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 80 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00986739 | ||||
| Other Study ID Numbers ICMJE | AOM 08205 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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