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

July 22, 2016 updated by: CHU de Reims

Frail Elderly Subjects: Inhospital Pathways and Adverse Outcome After Hospitalisation Via Emergency Department

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%).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Reims
      • France, Reims, France, 51092
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: up to 36 months
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 44N98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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