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Completed

NCT Number: NCT02834728

Frail Elderly Subjects - Evaluation and Follow-Up

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%).

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Reims

France, Reims, 51092

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone Interview

Behavioral

Primary outcomes

  1. Mortality

    Time frame: up to 36 months

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: SAFES Cohort

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Jul 15, 2016
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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