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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04175236

Enrollment

Registered

2019-11-22

Start date

2018-06-19

Completion date

2019-11-04

Last updated

2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postintensive Care Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Subjective Health II	06/2018 - 11/2019	Patients were asked to rate their quality of life, measured by EQ-5D-5L
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).
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).

Countries

Germany

Outcome results