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

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)

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Assessment, Self; Self-Assessment
• Intervention / Treatment: Other: WHODAS 2.0; Other: EQ5D; Other: IADL; Other: Barthel-Score; Other: SF-36; Other: MoCA Blind

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar, School of Medicine, Technical University of Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Surgical patients with a high risk to be admitted to intensive care

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intensive Care Patients; Postoperative patients who have been admitted to intensive care	Other: WHODAS 2.0; WHO Disability Score; Other: EQ5D; Health related quality of life measured with European Quality of Life 5 Dimensions 5 Level; Other: IADL; The Lawton Instrumental Activities of Daily Living; Other: Barthel-Score; Barthel Score of the patient; Other: SF-36; Short Form Health 36; Other: MoCA Blind; Montreal Cognitive Assessment
Non-Intensive Care Patients; Postoperative patients who have not been admitted to intensive care but to the normal ward	Other: WHODAS 2.0; WHO Disability Score; Other: EQ5D; Health related quality of life measured with European Quality of Life 5 Dimensions 5 Level; Other: IADL; The Lawton Instrumental Activities of Daily Living; Other: Barthel-Score; Barthel Score of the patient; Other: SF-36; Short Form Health 36; Other: MoCA Blind; Montreal Cognitive Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Charite University, Berlin, Germany; Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion
• Investigators: Principal Investigator: Steffen Weber-Carstens, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: SF-36; functional status; Intensive care; Critically ill; EQ5D; WHODAS; Assessment by others; Self-Assessment; standardized questionnaire; IADL; Barthel Score; MoCA Blind
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: ASTON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties.

Examples of reasonable requests are:

• a metaanalysis in the field
• a research collaboration
• rerun the analysis

Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No