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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03785444
Acronym
ASTON
Enrollment
200
Registered
2018-12-24
Start date
2019-02-25
Completion date
2020-08-15
Last updated
2020-10-06

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

Conditions

Critical Illness, Self-Assessment, Assessment, Self

Keywords

Assessment by others, Self-Assessment, Critically ill, Intensive care, standardized questionnaire, functional status, WHODAS, EQ5D, IADL, Barthel Score, SF-36, MoCA Blind

Brief summary

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.

Interventions

OTHERWHODAS 2.0

WHO Disability Score

OTHEREQ5D

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

OTHERIADL

The Lawton Instrumental Activities of Daily Living

OTHERBarthel-Score

Barthel Score of the patient

OTHERSF-36

Short Form Health 36

OTHERMoCA Blind

Montreal Cognitive Assessment

Sponsors

Charite University, Berlin, Germany
CollaboratorOTHER
Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion
CollaboratorUNKNOWN
Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Agreement in assessment of ICU patients2 weeks before hospital admissionComparison of results of self-assessment versus assessment by others of standardized questionnaires of postoperative patients admitted to intensive care

Secondary

MeasureTime frameDescription
Agreement in assessment of ICU vs. non-ICU patients2 weeks before hospital admissionComparison of results of assessment of questionnaires of ICU patients vs. non-ICU patients
Agreement in assessment of non-ICU patients2 weeks before hospital admissionComparison 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
Multivariate testing using the closeness of the relationship2 weeks before hospital admissionIt 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

MeasureTime frameDescription
Definition of criteria which define an appropriate close relationship to receive a reliable test result2 weeks before hospital admissionTest which closeness of relationship is sufficient to provide adequate test results compared with the patient's answers

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026