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

NCT03785444 | Completed

• 1 other identifier: ASTON
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  2 weeks before hospital admission

• Agreement in assessment of non-ICU patients

  2 weeks before hospital admission

• Multivariate testing using the closeness of the relationship

  2 weeks before hospital admission

Other Outcomes (1)

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

  2 weeks before hospital admission

Study Arms (2)

Intensive Care Patients

Postoperative patients who have been admitted to intensive care

Other: WHODAS 2.0; Other: EQ5D; Other: IADL; Other: Barthel-Score; Other: SF-36; Other: MoCA Blind

Non-Intensive Care Patients

Postoperative patients who have not been admitted to intensive care but to the normal ward

Other: WHODAS 2.0; Other: EQ5D; Other: IADL; Other: Barthel-Score; Other: SF-36; Other: MoCA Blind

Interventions

WHODAS 2.0 OTHER

WHO Disability Score

Intensive Care Patients; Non-Intensive Care Patients

EQ5D OTHER

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

Intensive Care Patients; Non-Intensive Care Patients

IADL OTHER

The Lawton Instrumental Activities of Daily Living

Intensive Care Patients; Non-Intensive Care Patients

Barthel-Score OTHER

Barthel Score of the patient

Intensive Care Patients; Non-Intensive Care Patients

SF-36 OTHER

Short Form Health 36

Intensive Care Patients; Non-Intensive Care Patients

MoCA Blind OTHER

Montreal Cognitive Assessment

Intensive Care Patients; Non-Intensive Care Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Charite University, Berlin, Germany: collaborator
• Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion: collaborator

Study Sites (2)

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

Munich, Bavaria, 81675, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (1)

• Grunow JJ, Hartmann L, Ulm B, Maechler M, Blobner M, Seidenspinner K, Schoennagel L, Weber-Carstens S, Fuest K, Wollersheim T, Schaller SJ. Reliability of pre-admission patient-reported outcome measures postoperatively assessed via proxies: a prospective, multicenter observational study. Crit Care. 2025 May 19;29(1):200. doi: 10.1186/s13054-025-05431-6.

  PMID: 40390142 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan J Schaller, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

• Steffen Weber-Carstens, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 24, 2018
• Study Start: February 25, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

DE (2)