- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Haut-de-France
-
Lille, Haut-de-France, Frankrike, 59000
- Saint-Vincent Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Identification of predictive factors of robustness : Autonomy level at home (ADL score)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 3 months
|
Number of family visits
|
3 months
|
Identification of predictive factors of robustness by a questionnaire (appetit)
Tidsramme: 3 months
|
loss of appetite (yes or not)
|
3 months
|
Identification of predictive factors of robustness (heart rate)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 3 months
|
Body mass index
|
3 months
|
Albuminemia
Tidsramme: 3 months
|
Rate of Albuminemia
|
3 months
|
Identification of predictive factors of robustness : Lifestyle
Tidsramme: 3 months
|
Lifestyle: person living alone (yes or not)
|
3 months
|
Sleep assessment using a Visual Analog Scale (VAS).
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Rate of re-hospitalization
Tidsramme: 3 months
|
Only direct re-hospitalizations in emergency rooms and geriatric short stay will be counted
|
3 months
|
Rate of patient survival
Tidsramme: 3 months
|
Rate of patient survival
|
3 months
|
Rate of lack of Institutionalization
Tidsramme: 3 months
|
Rate of lack of Institutionalization
|
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jean Bouquillon, Hôpital Saint-Vincent de Paul
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RC-P0099
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .