Longitudinal Prospective Study in a Mixed ICU Population
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|ClinicalTrials.gov Identifier: NCT03714230|
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
|Condition or disease|
|Intensive Care Patients|
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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||The Trajectory of Functional Status During the First Year After ICU Admission.|
|Actual Study Start Date :||September 28, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
- A cohort study on change of Functional Status during the first year after an ICU admission [ Time Frame: September 2018- May 2020 ]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
- The investigation of 5 pre-selected symptoms during the ICU stay [ Time Frame: 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.
- Cognitive functioning one year after ICU admission in a mixed ICU population [ Time Frame: September 2018 - December 2020 ]Cognitive functioning will be measured using self-report with the Cognitive Failure Questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714230
|Oslo Univesity hospital|
|Oslo, Norway, 0424|
|Principal Investigator:||Tone Rustøen, Professor||Oslo University Hospital and Oslo University|