- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03714230
Longitudinal Prospective Study in a Mixed ICU Population
The Trajectory of Functional Status During the First Year After ICU Admission.
연구 개요
상태
정황
상세 설명
For this study data will be collected using self-report questionnaires for the long-term outcome (e.g functional status) and several covariates (e.g., cognition, anxiety and depression, PTSD, QOL, general symptoms, frailty). To retrieve baseline data from prior ICU admission, family members will be used as proxy reporters at inclusion. During treatment in the ICU, patients will be mapped for 5 pre-selected symptoms every day for 7 days, or until death or ICU discharge. Several clinical variables (e.g., SOFA score, pain score, level of sedation, mobilization, medication, mouth care) will be collected daily until maximum 7 days. Follow-up data will be collected at 3, 6 and 12 months after ICU admission using self-report questionnaires.
The predictive value of pre-morbid condition prior to ICU admission on functional status during the first year after an ICU admission will be investigated, when controlled for various clinical and demographic variables. As a secondary analyses, the present study will identify both the occurrence of symptoms as well as the severity and distress of each symptom, while in the ICU. Another secondary outcome that will be measured in this longitudinal study is the association between cognitive function one year after an ICU admission and various mental health variables (PTSD, anxiety and depression).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Oslo, 노르웨이, 0424
- Oslo Univesity 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 that are > 18 years and
- Meet the criteria of Norwegian Intensive Register (NIR) for being an intensive care patient. The criteria include any on the following criteria:
- The need of mechanical ventilation, or
- The need of continuous inotropi, or
- 24 hours or more on an ICU, when continuous monitoring is needed, or
- Dies at the ICU within the first 24 hours, or
- Transferred to another ICU within the first 24 hours
Exclusion Criteria:
- Re-admissions to the ICU (within 72 hours from last ICU discharge)
- Pre-defined cognitive deficit (e.g. dementia)
- Homeless
- Unable to read and Write Norwegian
- Not included in the study within the first 48 hours since admission to the ICU
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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A cohort study on change of Functional Status during the first year after an ICU admission
기간: September 2018- May 2020
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Data on functional status will be collected using PROMS (e.g
Katz index and Lawton IADL) at baseline, and then after 3, 6 and 12 months.
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September 2018- May 2020
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The investigation of 5 pre-selected symptoms during the ICU stay
기간: September 2018 - December 2020
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A modified version of the Patient Symptom Survey (PSS) checklist will be used as self-report by the ICU patient when possible or by the clinical nurse as a proxy reporter.
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September 2018 - December 2020
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Cognitive functioning one year after ICU admission in a mixed ICU population
기간: September 2018 - December 2020
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Cognitive functioning will be measured using self-report with the Cognitive Failure Questionnaire, and proxy reported by IQCODE and CFQ at baseline.
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September 2018 - December 2020
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Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope
기간: January 2020 - December 2021
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Posttraumatic stress symptoms will be measured using self-report with the Impact of event scale-revised questionnaire.
Hope will be measured with the Herth Hope Index.
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January 2020 - December 2021
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Tone Rustøen, Professor, Oslo University Hospital and Oslo University
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
- 2017/990
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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