- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
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Haut-de-France
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Lille, Haut-de-France, France, 59000
- Saint-Vincent Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Identification of predictive factors of robustness : Autonomy level at home (ADL score)
Délai: 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)
Délai: 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)
Délai: 3 months
|
Number of family visits
|
3 months
|
|
Identification of predictive factors of robustness by a questionnaire (appetit)
Délai: 3 months
|
loss of appetite (yes or not)
|
3 months
|
|
Identification of predictive factors of robustness (heart rate)
Délai: 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
Délai: 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)
Délai: 3 months
|
Body mass index
|
3 months
|
|
Albuminemia
Délai: 3 months
|
Rate of Albuminemia
|
3 months
|
|
Identification of predictive factors of robustness : Lifestyle
Délai: 3 months
|
Lifestyle: person living alone (yes or not)
|
3 months
|
|
Sleep assessment using a Visual Analog Scale (VAS).
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of re-hospitalization
Délai: 3 months
|
Only direct re-hospitalizations in emergency rooms and geriatric short stay will be counted
|
3 months
|
|
Rate of patient survival
Délai: 3 months
|
Rate of patient survival
|
3 months
|
|
Rate of lack of Institutionalization
Délai: 3 months
|
Rate of lack of Institutionalization
|
3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jean Bouquillon, Hopital Saint-Vincent de Paul
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC-P0099
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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