- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683380
Robustness Predictive Factors in People Aged Over 75 Years After Going to the Emergency Room (ROB-U) (ROB-U)
Study of the Robustness Predictive Factors in People Aged Over 75 Years After Going to the Emergency Room
Study Overview
Status
Conditions
Detailed Description
The emergency department is one of the main access routes to the hospital for elderly patients.
Older age is often associated with an increase risk of longer stay in the emergency room with a high subsequent risk of hospital re-admission. One of the essential care objectives when treating these patients is to maintain the autonomy to avoid any dependence in order to keep the quality of life, and limit the time of hospitalization.
Emergency room visits and hospitalizations are too often considered as a source of autonomy loss aggravation in the elderly. Many studies have demonstrated the mortality predictive factors existence, functional decline, or re-hospitalization of the elderly after an emergency room visit or after hospitalization.
No study until now has investigated the existence of factors directly predictive of robustness. Then the goal of this study is to demonstrate that there are robustness predictive factors after going to the emergency room.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Haut-de-France
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Lille, Haut-de-France, France, 59000
- Saint-Vincent Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients admitted to the emergency room
- Patients aged ≥ 75 years old
- Patients without cognitive disorders or vigilance disorders
- Patients living at home
- Patients able to give its non-opposition
Non inclusion Criteria:
- Patients admitted to the hospital in the last 3 months
- Patients refusing to participate in the study
Exclusion Criteria:
- Patients whose stay is < 14h or > 48h
- Patients who die during hospitalization
- Patient not hospitalized
- Patient not returning home after discharge from hospital
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of predictive factors of robustness : Autonomy level at home (ADL score)
Time Frame: 3 months
|
ADL self-performance coding ranges from 0 (independent) to 4 (total dependence).
|
3 months
|
|
Identification of predictive factors of robustness by a questionnaire (help at home)
Time Frame: 3 months
|
Need of help at home such as : toilet, breakfast, lunch, dinner (yes or not)
|
3 months
|
|
Identification of predictive factors of robustness by a questionnaire (family visits)
Time Frame: 3 months
|
Number of family visits
|
3 months
|
|
Identification of predictive factors of robustness by a questionnaire (appetit)
Time Frame: 3 months
|
loss of appetite (yes or not)
|
3 months
|
|
Identification of predictive factors of robustness (heart rate)
Time Frame: 3 months
|
Heart rate during hospitalization (minimum and maximum values)
|
3 months
|
|
Identification of predictive factors of robustness (Modified Triage Risk Screening Tool (TRST)) score
Time Frame: 3 months
|
The TRST score is a tool to predict repeat emergency department visits and hospitalizations in older patients discharged from the emergency department; This tool evaluates 5 dimensions : cognitive disorders presence, walking disorders, polymedication, hospitalization antecedents and functional assessment (loss of autonomy).
Every dimension is worth 1 point if the patient presents the disorder.
The final maximum score is 5 points.
|
3 months
|
|
Identification of predictive factors of robustness : BMI (Body Mass Index)
Time Frame: 3 months
|
Body mass index
|
3 months
|
|
Albuminemia
Time Frame: 3 months
|
Rate of Albuminemia
|
3 months
|
|
Identification of predictive factors of robustness : Lifestyle
Time Frame: 3 months
|
Lifestyle: person living alone (yes or not)
|
3 months
|
|
Sleep assessment using a Visual Analog Scale (VAS).
Time Frame: 3 months
|
This scale allows patients to assess their fatigue.
The patients locate their fatigue intensity on a 100-millimeters horizontal line.
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
A higher score indicates greater pain intensity.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of re-hospitalization
Time Frame: 3 months
|
Only direct re-hospitalizations in emergency rooms and geriatric short stay will be counted
|
3 months
|
|
Rate of patient survival
Time Frame: 3 months
|
Rate of patient survival
|
3 months
|
|
Rate of lack of Institutionalization
Time Frame: 3 months
|
Rate of lack of Institutionalization
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean Bouquillon, Hôpital Saint-Vincent de Paul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-P0099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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