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

Completed

• Conditions: Self-Assessment; Critical Illness; Assessment, Self
• Interventions: Other: WHODAS 2.0; Other: EQ5D; Other: IADL; Other: Barthel-Score; Other: SF-36; Other: MoCA Blind

• Registration Number: NCT03785444
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-24
• Study Start: 2019-02-25
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Intensive Care Patients	WHODAS 2.0	Postoperative patients who have not been admitted to intensive care but to the normal ward
Non-Intensive Care Patients	IADL	Postoperative patients who have not been admitted to intensive care but to the normal ward
Intensive Care Patients	Barthel-Score	Postoperative patients who have been admitted to intensive care
Intensive Care Patients	SF-36	Postoperative patients who have been admitted to intensive care
Intensive Care Patients	MoCA Blind	Postoperative patients who have been admitted to intensive care
Intensive Care Patients	WHODAS 2.0	Postoperative patients who have been admitted to intensive care
Intensive Care Patients	EQ5D	Postoperative patients who have been admitted to intensive care
Intensive Care Patients	IADL	Postoperative patients who have been admitted to intensive care
Non-Intensive Care Patients	EQ5D	Postoperative patients who have not been admitted to intensive care but to the normal ward
Non-Intensive Care Patients	MoCA Blind	Postoperative patients who have not been admitted to intensive care but to the normal ward
Non-Intensive Care Patients	SF-36	Postoperative patients who have not been admitted to intensive care but to the normal ward
Non-Intensive Care Patients	Barthel-Score	Postoperative patients who have not been admitted to intensive care but to the normal ward

Primary Outcome Measures

Name	Time	Method
Agreement in assessment of ICU patients	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 Outcome Measures

Name	Time	Method
Agreement in assessment of ICU vs. non-ICU patients	2 weeks before hospital admission	Comparison of results of assessment of questionnaires of ICU patients vs. non-ICU patients
Agreement in assessment of non-ICU patients	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
Multivariate testing using the closeness of the relationship	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

Trial Locations

Locations (2)

Klinikum rechts der Isar, School of Medicine, Technical University of Munich; 🇩🇪 Munich, Bavaria, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany