- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Haut-de-France
-
Lille, Haut-de-France, Frankreich, 59000
- Saint-Vincent Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Identification of predictive factors of robustness : Autonomy level at home (ADL score)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 3 months
|
Number of family visits
|
3 months
|
Identification of predictive factors of robustness by a questionnaire (appetit)
Zeitfenster: 3 months
|
loss of appetite (yes or not)
|
3 months
|
Identification of predictive factors of robustness (heart rate)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 3 months
|
Body mass index
|
3 months
|
Albuminemia
Zeitfenster: 3 months
|
Rate of Albuminemia
|
3 months
|
Identification of predictive factors of robustness : Lifestyle
Zeitfenster: 3 months
|
Lifestyle: person living alone (yes or not)
|
3 months
|
Sleep assessment using a Visual Analog Scale (VAS).
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Rate of re-hospitalization
Zeitfenster: 3 months
|
Only direct re-hospitalizations in emergency rooms and geriatric short stay will be counted
|
3 months
|
Rate of patient survival
Zeitfenster: 3 months
|
Rate of patient survival
|
3 months
|
Rate of lack of Institutionalization
Zeitfenster: 3 months
|
Rate of lack of Institutionalization
|
3 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jean Bouquillon, Hôpital Saint-Vincent de Paul
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RC-P0099
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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