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

Postintensive Care Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175236
• Other study ID #: PICS
• Status: Completed
• Start date: June 19, 2018
• Est. completion date: November 4, 2019

Study information

• Verified date: March 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postintensive Care Syndrome
• Syndrome

Locations

Country	Name	City	State
Germany	Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum	Bad Belzig
Germany	Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Claudia Spies

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Intensive Care Syndrome (PICS)	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).	06/2018 - 11/2019
Secondary	Subjective Health I	Patients were asked to rate their quality of life, measured by EQ-5D-3L	06/2018 - 11/2019
Secondary	Subjective Health II	Patients were asked to rate their quality of life, measured by EQ-5D-5L	06/2018 - 11/2019
Secondary	Subjective Health III	Patients were asked to rate their quality of life, measured by WHO Disability Assessment Schedule (WHODAS 2.0)	06/2018 - 11/2019
Secondary	Mental Health	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).	06/2018 - 11/2019
Secondary	Cognition	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).	06/2018 - 11/2019
Secondary	Physical Health	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).	06/2018 - 11/2019