Longitudinal Prospective Study in a Mixed ICU Population
The Trajectory of Functional Status During the First Year After ICU Admission.
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Oslo、ノルウェー、0424
- Oslo Univesity hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
A cohort study on change of Functional Status during the first year after an ICU admission
時間枠: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.
|
September 2018- May 2020
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The investigation of 5 pre-selected symptoms during the ICU stay
時間枠:September 2018 - December 2020
|
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.
|
September 2018 - December 2020
|
|
Cognitive functioning one year after ICU admission in a mixed ICU population
時間枠:September 2018 - December 2020
|
Cognitive functioning will be measured using self-report with the Cognitive Failure Questionnaire, and proxy reported by IQCODE and CFQ at baseline.
|
September 2018 - December 2020
|
|
Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope
時間枠: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.
|
January 2020 - December 2021
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Tone Rustøen, Professor、Oslo University Hospital and Oslo University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2017/990
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。