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

Completed

• Conditions: Postintensive Care Syndrome

• Registration Number: NCT04175236
• Lead Sponsor: Claudia Spies

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-19
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post Intensive Care Syndrome (PICS)	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 Outcome Measures

Name	Time	Method
Subjective Health II	06/2018 - 11/2019	Patients were asked to rate their quality of life, measured by EQ-5D-5L
Mental Health	06/2018 - 11/2019	Mental health of the patient is measured by the sum scores of the following outcome measurement instruments: Patient Health Questionnaire (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).
Subjective Health III	06/2018 - 11/2019	Patients were asked to rate their quality of life, measured by WHO Disability Assessment Schedule (WHODAS 2.0)
Subjective Health I	06/2018 - 11/2019	Patients were asked to rate their quality of life, measured by EQ-5D-3L
Cognition	06/2018 - 11/2019	Cognition is measured by the sum scores of the following outcome measurement instruments: MiniCog, Animal Naming Test, Trail Making Test (TMT-A, TMT-B), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Physical Health	06/2018 - 11/2019	Physical health is measured by the sum scores of the following outcome measurement instruments: Timed Up-and-Go (TUG), Handgrip Strength, 2-Minute Walk Test (2-MWT), Short Physical Performance Battery (SPPB).

Trial Locations

Locations (2)

Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum; 🇩🇪 Bad Belzig, Germany

Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany