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

Critical Illness Clinical Trial

— ASTON  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03785444
• Other study ID #: ASTON
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: August 15, 2020

Study information

• Verified date: October 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Assessment, Self
• Critical Illness
• Self-Assessment

Intervention

Other:
• WHODAS 2.0
WHO Disability Score
• EQ5D
Health related quality of life measured with European Quality of Life 5 Dimensions 5 Level
• IADL
The Lawton Instrumental Activities of Daily Living
• Barthel-Score
Barthel Score of the patient
• SF-36
Short Form Health 36
• MoCA Blind
Montreal Cognitive Assessment

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Klinikum rechts der Isar, School of Medicine, Technical University of Munich	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität München	Charite University, Berlin, Germany, Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Definition of criteria which define an appropriate close relationship to receive a reliable test result	Test which closeness of relationship is sufficient to provide adequate test results compared with the patient's answers	2 weeks before hospital admission
Primary	Agreement in assessment of ICU patients	Comparison of results of self-assessment versus assessment by others of standardized questionnaires of postoperative patients admitted to intensive care	2 weeks before hospital admission
Secondary	Agreement in assessment of ICU vs. non-ICU patients	Comparison of results of assessment of questionnaires of ICU patients vs. non-ICU patients	2 weeks before hospital admission
Secondary	Agreement in assessment of non-ICU patients	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	2 weeks before hospital admission
Secondary	Multivariate testing using the closeness of the relationship	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	2 weeks before hospital admission