Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty. (FRAGIREA)

August 13, 2019 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
527

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
      • Aix-en-Provence, France
        • CH Aix en Provence
      • Angers, France
        • CHU Angers
      • Annecy, France
        • CH Annecy
      • Annonay, France
        • Ch Annonay
      • Argenteuil, France
        • CH Argentueil
      • Belfort, France
        • CH Belfort
      • Bourg-en-Bresse, France
        • CH Bourg en Bresse
      • Bourgoin-Jallieu, France
        • CH Bourgoin-Jallieu
      • Béziers, France
        • Ch Beziers
      • Chalon-sur-Saône, France
        • CH Chalons sur Saône
      • Chambéry, France
        • CH Chambery
      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand
      • La Tronche, France
        • CHU Grenoble
      • Lyon, France, 69003
        • Hôpital Edouard Herriot, G Réa
      • Lyon, France, 69003
        • Hôpital Edouard Herriot, N réa
      • Lyon, France, 69003
        • Hôpital Edouard Herriot, P Réa
      • Lyon, France, 69005
        • Hôpital de la Croix Rousse
      • Marseille, France
        • AP-HM Hopital Nord
      • Marseille, France
        • Ap-Hm La Timone
      • Montauban, France
        • CH Montauban
      • Montélimar, France
        • CH Montélimar
      • Moulins, France
        • Ch Moulins
      • Nantes, France
        • CHU Nantes
      • Nice, France
        • CHU Nice
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud Réa Nord
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France
        • Chu Rennes
      • Rennes, France
        • CHU de Rennes
      • Rouen, France
        • CHU Rouen
      • Saint-Denis, France
        • CH Saint Denis
      • Saint-Étienne, France
        • CHU Hopital Nord
      • Salon-de-Provence, France
        • CH Salons de Provence
      • Valence, France
        • CH Valence
      • Vichy, France
        • CH Vichy
      • Évry, France
        • Ch Sud Francilien
  • Mayotte
      • Mayotte, Mayotte
        • CH Mayotte

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients ≥ 70 year-old admitted to an ICU.

Description

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • 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,
  • subject participating in another search including an exclusion period still in progress at pre-inclusion

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
frailty group
frailty score ≤ 3
Other: Frailty in elderly (≥70 y) patients in ICU
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
non-frailty group
frailty score >3
Other: Frailty in elderly (≥70 y) patients in ICU
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)
Time Frame: One month or 15 patients ≥ 70 years old
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Organ failures
Time Frame: About 8 days

During the patients' hospitalization in ICU, the following data were collected last day in ICU:

the need for dialysis during ICU the duration of mechanical ventilation (number of days under mechanical ventilation) the duration of shock (number of days under catecholamines)
About 8 days
Nutritional support
Time Frame: About 8 days

Nutritional intake during ICU stay, from the first day to the patient's exit, including route of administration (enteral, parenteral), last day in ICU we assessed:

number of days under enteral nutrition number of days under enteral parenteral nutrition calculation of the average calorie / day
About 8 days
Rehabilitation
Time Frame: About 8 days
Last day in ICU, we record the highest level of mobilization achieved during the ICU period, the following ordinal scale was used: 1) no mobilization, 2) turning in bed, 3) sitting in bed with the head of bed elevated, 4) sitting on the edge of the bed with feet on floor, 5) sitting out of bed in a chair, 6) standing out of bed, 7) marching in place, 8) walking, 9) using cycloergometer and 9) using electrical muscle stimulation.
About 8 days
Mortality
Time Frame: 90 days
ICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).
90 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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