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Clinical Trials/NCT04175236
NCT04175236
Completed
Not Applicable

Analysis of a Short Assessment of Post Intensive Care Syndrome (PICS)

Claudia Spies2 sites in 1 country9 target enrollmentJune 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postintensive Care Syndrome
Sponsor
Claudia Spies
Enrollment
9
Locations
2
Primary Endpoint
Post Intensive Care Syndrome (PICS)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

To present a proposal for a set of outcome measurement instruments (OMIs) of post intensive care syndrome (PICS) in settings of outpatient healthcare service.

Registry
clinicaltrials.gov
Start Date
June 19, 2018
End Date
November 4, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Claudia Spies

Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • Patients aged ≥ 18 years, whose intensive care treatment has already been completed
  • The patients were interviewed in the Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum, Bad Belzig, as well as in the pain clinic of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Exclusion Criteria

  • Patients with a legal guardian or authorized representative

Outcomes

Primary Outcomes

Post Intensive Care Syndrome (PICS)

Time Frame: 06/2018 - 11/2019

The composite outcome measure "PICS" of the patient is measured according to Needham et al 2012: new impairment or worsening of health after intensive care unit stay and at the same time clinically significant distress in at least one of the following outcome measurement instruments: Patient Health Questionnaires (PHQ-9, PHQ-8, PHQ-4), Generalized Anxiety Disorder Scale-7 (GAD-7), Impact of Event Scale (IES), Impact of Event Scale Revised (IES-R), MiniCog, Animal Naming Test, Trail Making Test (TMT-A, TMT-B), Repeatable Battery for the Assessment of Neuropsychological Satus (RBANS), Timed Up-and-Go (TUG), Handgrip Strength, 2-Minute Walk Test (2-MWT), Short Physical Performance Battery (SPPB).

Secondary Outcomes

  • Subjective Health II(06/2018 - 11/2019)
  • Mental Health(06/2018 - 11/2019)
  • Subjective Health III(06/2018 - 11/2019)
  • Subjective Health I(06/2018 - 11/2019)
  • Cognition(06/2018 - 11/2019)
  • Physical Health(06/2018 - 11/2019)

Study Sites (2)

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