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Completed

NCT Number: NCT04175236

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

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

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Key information

Conditions

Postintensive Care Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum, Bad Belzig, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Subjective Health I

    Time frame: 06/2018 - 11/2019

    Patients were asked to rate their quality of life, measured by EQ-5D-3L

  2. Subjective Health II

    Time frame: 06/2018 - 11/2019

    Patients were asked to rate their quality of life, measured by EQ-5D-5L

  3. Subjective Health III

    Time frame: 06/2018 - 11/2019

    Patients were asked to rate their quality of life, measured by WHO Disability Assessment Schedule (WHODAS 2.0)

  4. Mental Health

    Time frame: 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).

  5. Cognition

    Time frame: 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).

  6. Physical Health

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Claudia Spies

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2019
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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