Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.
FRAGIREA
1 other identifier
observational
527
2 countries
37
Brief Summary
Study design. The study FRAGIREA is a multicentric prevalence study on the frequency of frailty among elderly patients and the quality of management. The voluntary ICUs will have to include all patients ≥ 70 years on a limited period (1 month) or until the number of 15 inclusions is reached. The frailty is going to be evaluated by a frailty score adapted to the ICU, based on informations given by the patient's family. It is a descriptive non-interventional study, aiming at the description of frequency of frailty and management of the patient in order to set-up a prospective future study on the potential role of early rehabilitation of ageing patients in ICUs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
April 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2019
CompletedAugust 14, 2019
August 1, 2019
10 months
October 17, 2017
August 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)
We assessed the 5 components of Fried's frailty index, resulting from cumulative decline across multiple physiological systems and contain five criteria (shrinking, weakness, slowness, low-level physical activity, and self-reported exhaustion). All five components were considered from the previously reported definition and adapted to the ICU environment. The patients were considered to be frail if they had three or more frailty components among the five criteria.
One month or 15 patients ≥ 70 years old
Secondary Outcomes (4)
Organ failures
About 8 days
Nutritional support
About 8 days
Rehabilitation
About 8 days
Mortality
90 days
Study Arms (2)
frailty group
frailty score ≤ 3
non-frailty group
frailty score \>3
Interventions
Determine the prevalence of frailty in elderly patients (≥ 70 year old) in a group of French ICUs. The frailty is measured by a score (Fried score) at the admission of the patient
Eligibility Criteria
Patients ≥ 70 year-old admitted to an ICU.
You may qualify if:
- ≥ 70 year-old
- Prevision of a length of stay \> 24 hrs.
- Patient or relative who received information about the study and did not oppose it
You may not qualify if:
- Life expectancy \< 24 hrs
- Patients unable to communicate and no next of kin available.
- adults, non-emancipated minors, persons unable to receive information,
- persons placed under the safeguard of justice,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
CH Aix en Provence
Aix-en-Provence, France
CHU Angers
Angers, France
CH Annecy
Annecy, France
CH Annonay
Annonay, France
CH Argentueil
Argenteuil, France
CH Belfort
Belfort, France
CH Béziers
Béziers, France
CH Bourg en Bresse
Bourg-en-Bresse, France
CH Bourgoin-Jallieu
Bourgoin, France
CH Chalons sur Saône
Chalon-sur-Saône, France
CH Chambéry
Chambéry, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CH Sud Francilien
Évry, France
CHU Grenoble
La Tronche, France
Hôpital Edouard Herriot, G Réa
Lyon, 69003, France
Hôpital Edouard Herriot, N réa
Lyon, 69003, France
Hôpital Edouard Herriot, P Réa
Lyon, 69003, France
Hôpital de la Croix Rousse
Lyon, 69005, France
AP-HM Hôpital Nord
Marseille, France
AP-HM La Timone
Marseille, France
CH Montauban
Montauban, France
CH Montélimar
Montélimar, France
CH Moulins
Moulins, France
CHU Nantes
Nantes, France
CHU Nice
Nice, France
Centre Hospitalier Lyon Sud Réa Nord
Pierre-Bénite, 69495, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Poitiers
Poitiers, France
CHU de Rennes
Rennes, France
CHU Rennes
Rennes, France
CHU Rouen
Rouen, France
CH Saint Denis
Saint-Denis, France
CHU Hôpital Nord
Saint-Etienne, France
CH Salons de Provence
Salon-de-Provence, France
CH Valence
Valence, France
CH Vichy
Vichy, France
CH Mayotte
Mayotte, Mayotte
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 31, 2017
Study Start
April 8, 2018
Primary Completion
January 25, 2019
Study Completion
July 24, 2019
Last Updated
August 14, 2019
Record last verified: 2019-08