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Completed

NCT Number: NCT03785444

Comparison of Self-assessment vs. Assessment by Others of Critically Ill Patients

We will test the results of standardized questionnaires for patients admitted to intensive care assessed by relatives/caregivers compared to the patient itself. Furthermore we will compare results with patients not admitted to intensive care.

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Key information

Conditions

Critical Illness Assessment, Self Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Self-Assessment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar, School of Medicine, Technical University of Munich, Munich, Bavaria, 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

  • patient with a postoperative risk to be admitted to intensive care
  • signed informed consent

Exclusion criteria

  • patient who is not able to fill out the questionnaires alone and independent
  • patient without relatives or a caregiver who could answer the assessment after surgery

Treatment and study plan

WHODAS 2.0

Other

WHO Disability Score

EQ5D

Other

Health related quality of life measured with European Quality of Life 5 Dimensions 5 Level

IADL

Other

The Lawton Instrumental Activities of Daily Living

Barthel-Score

Other

Barthel Score of the patient

SF-36

Other

Short Form Health 36

MoCA Blind

Other

Montreal Cognitive Assessment

Primary outcomes

  1. Agreement in assessment of ICU patients

    Time frame: 2 weeks before hospital admission

    Comparison of results of self-assessment versus assessment by others of standardized questionnaires of postoperative patients admitted to intensive care

Secondary outcomes

  1. Agreement in assessment of ICU vs. non-ICU patients

    Time frame: 2 weeks before hospital admission

    Comparison of results of assessment of questionnaires of ICU patients vs. non-ICU patients

  2. Agreement in assessment of non-ICU patients

    Time frame: 2 weeks before hospital admission

    Comparison of results of self-assessment versus assessment by others of standardized questionnaires of postoperative patients not admitted to intensive care but to the normal ward

  3. Multivariate testing using the closeness of the relationship

    Time frame: 2 weeks before hospital admission

    It will be tested if the closeness of relationship patient - relative/caregiver changes the agreement, i.e. if the agreement is dependent or independent of the closeness of the relationship

Other outcomes

  1. Definition of criteria which define an appropriate close relationship to receive a reliable test result

    Time frame: 2 weeks before hospital admission

    Test which closeness of relationship is sufficient to provide adequate test results compared with the patient's answers

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Charite University, Berlin, Germany
  • Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion

Registry information

Official study title

Agreement in Relatives' Assessment in Standardized Questionnaires of Patients Who Have Been Admitted to Intensive Care Compared to Patients Who Have Not Been Admitted to Intensive Care (ASTON Study)

Acronym: ASTON

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2018
Registry last updated
Oct 6, 2020

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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