- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Haut-de-France
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Lille, Haut-de-France, Francia, 59000
- Saint-Vincent Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Identification of predictive factors of robustness : Autonomy level at home (ADL score)
Periodo de tiempo: 3 months
|
ADL self-performance coding ranges from 0 (independent) to 4 (total dependence).
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3 months
|
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Identification of predictive factors of robustness by a questionnaire (help at home)
Periodo de tiempo: 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)
Periodo de tiempo: 3 months
|
Number of family visits
|
3 months
|
|
Identification of predictive factors of robustness by a questionnaire (appetit)
Periodo de tiempo: 3 months
|
loss of appetite (yes or not)
|
3 months
|
|
Identification of predictive factors of robustness (heart rate)
Periodo de tiempo: 3 months
|
Heart rate during hospitalization (minimum and maximum values)
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3 months
|
|
Identification of predictive factors of robustness (Modified Triage Risk Screening Tool (TRST)) score
Periodo de tiempo: 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.
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3 months
|
|
Identification of predictive factors of robustness : BMI (Body Mass Index)
Periodo de tiempo: 3 months
|
Body mass index
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3 months
|
|
Albuminemia
Periodo de tiempo: 3 months
|
Rate of Albuminemia
|
3 months
|
|
Identification of predictive factors of robustness : Lifestyle
Periodo de tiempo: 3 months
|
Lifestyle: person living alone (yes or not)
|
3 months
|
|
Sleep assessment using a Visual Analog Scale (VAS).
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of re-hospitalization
Periodo de tiempo: 3 months
|
Only direct re-hospitalizations in emergency rooms and geriatric short stay will be counted
|
3 months
|
|
Rate of patient survival
Periodo de tiempo: 3 months
|
Rate of patient survival
|
3 months
|
|
Rate of lack of Institutionalization
Periodo de tiempo: 3 months
|
Rate of lack of Institutionalization
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean Bouquillon, Hopital Saint-Vincent de Paul
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RC-P0099
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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