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Frail Elderly Subjects - Evaluation and Follow-Up (SAFES Cohort)

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ClinicalTrials.gov Identifier: NCT02834728
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:
This was a prospective multicenter cohort study of elderly people admitted to medical wards via emergency departments. Subjects were followed up to 36 months. It aimed to study the inhospital pathways and adverse geriatric outcomes. In all, 1306 subjects were included : 85+/-5 years, and mainly women (65%).

Condition or disease Intervention/treatment
Frail Elderly People Behavioral: telephone interview

Detailed Description:
The SAFES cohort was formed within a National Research Program (funded by the French Ministry of health) into the recruitment of emergency units in nine teaching hospitals. All nine centres had a geriatric ward. The inclusion of subjects ran from March 1st 2001 to January 17th 2002. To be eligible, patients were to be 75 or over, to have been hospitalised in a medical ward in the same hospital as the emergency unit to which they were initially admitted. Subjects were not eligible if hospitalisation was into intensive care or surgery, or if admission did not occur after admission to the emergency unit. Every day in each centre, patients admitted to the emergency unit were registered. From the list thus obtained, patients were selected by random draw stratified at two levels: in each week, 5 days were selected randomly, and for each of these days, two patients were chosen randomly. Next, each patient was visited by a specialist in geriatrics familiar with the survey procedures. In the course of this interview, patients were informed about the study, prior to signing the consent form. If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. Follow-up was by telephone interview after the 1st, 8th and 21st month and by face-to-face interviews after the 5th, 12th, 18th, and 24th month following the initial hospitalisation. Several outcome have been studied.

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Study Type : Observational
Actual Enrollment : 1306 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Frail Elderly Subjects: Inhospital Pathways and Adverse Outcome After Hospitalisation Via Emergency Department
Study Start Date : March 2001
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Group/Cohort Intervention/treatment
Frail elderly people
A group of elderly people hospitalised in medical wards via emergency department
Behavioral: telephone interview



Primary Outcome Measures :
  1. Mortality [ Time Frame: up to 36 months ]


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients were selected randomly from the emergency department. Subjects were to 75 years or over, and admitted to a medical ward after emargency department stay. Those who were admitted to surgery or intensive care units were excluded from the study
Criteria

Inclusion Criteria:

  • Age of 75 years or over
  • Admitted to medical ward via emergency department
  • Consent to participate

Exclusion Criteria:

  • Not hospitalised after emergency department stay
  • Admitted to surgery or intensive car unit
  • Died before signing informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834728


Locations
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France
Chu Reims
France, Reims, France, 51092
Sponsors and Collaborators
CHU de Reims

Publications of Results:

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02834728     History of Changes
Other Study ID Numbers: 44N98
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016