- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
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Haut-de-France
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Lille, Haut-de-France, 프랑스, 59000
- Saint-Vincent Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Identification of predictive factors of robustness : Autonomy level at home (ADL score)
기간: 3 months
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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)
기간: 3 months
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Need of help at home such as : toilet, breakfast, lunch, dinner (yes or not)
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3 months
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Identification of predictive factors of robustness by a questionnaire (family visits)
기간: 3 months
|
Number of family visits
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3 months
|
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Identification of predictive factors of robustness by a questionnaire (appetit)
기간: 3 months
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loss of appetite (yes or not)
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3 months
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Identification of predictive factors of robustness (heart rate)
기간: 3 months
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Heart rate during hospitalization (minimum and maximum values)
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3 months
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Identification of predictive factors of robustness (Modified Triage Risk Screening Tool (TRST)) score
기간: 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
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Identification of predictive factors of robustness : BMI (Body Mass Index)
기간: 3 months
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Body mass index
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3 months
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Albuminemia
기간: 3 months
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Rate of Albuminemia
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3 months
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Identification of predictive factors of robustness : Lifestyle
기간: 3 months
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Lifestyle: person living alone (yes or not)
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3 months
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Sleep assessment using a Visual Analog Scale (VAS).
기간: 3 months
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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.
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3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of re-hospitalization
기간: 3 months
|
Only direct re-hospitalizations in emergency rooms and geriatric short stay will be counted
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3 months
|
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Rate of patient survival
기간: 3 months
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Rate of patient survival
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3 months
|
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Rate of lack of Institutionalization
기간: 3 months
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Rate of lack of Institutionalization
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3 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jean Bouquillon, Hôpital Saint-Vincent de Paul
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RC-P0099
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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