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

NCT ID: NCT03785444

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-25

Study Completion Date

2020-08-15

Brief Summary

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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

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Conditions

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Critical Illness Self-Assessment Assessment, Self

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive Care Patients

Postoperative patients who have been admitted to intensive care

WHODAS 2.0

Intervention Type OTHER

WHO Disability Score

EQ5D

Intervention Type OTHER

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

IADL

Intervention Type OTHER

The Lawton Instrumental Activities of Daily Living

Barthel-Score

Intervention Type OTHER

Barthel Score of the patient

SF-36

Intervention Type OTHER

Short Form Health 36

MoCA Blind

Intervention Type OTHER

Montreal Cognitive Assessment

Non-Intensive Care Patients

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

WHODAS 2.0

Intervention Type OTHER

WHO Disability Score

EQ5D

Intervention Type OTHER

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

IADL

Intervention Type OTHER

The Lawton Instrumental Activities of Daily Living

Barthel-Score

Intervention Type OTHER

Barthel Score of the patient

SF-36

Intervention Type OTHER

Short Form Health 36

MoCA Blind

Intervention Type OTHER

Montreal Cognitive Assessment

Interventions

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WHODAS 2.0

WHO Disability Score

Intervention Type OTHER

EQ5D

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

Intervention Type OTHER

IADL

The Lawton Instrumental Activities of Daily Living

Intervention Type OTHER

Barthel-Score

Barthel Score of the patient

Intervention Type OTHER

SF-36

Short Form Health 36

Intervention Type OTHER

MoCA Blind

Montreal Cognitive Assessment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion

UNKNOWN

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Steffen Weber-Carstens, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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

Munich, Bavaria, Germany

Site Status

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 40390142 (View on PubMed)

Other Identifiers

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ASTON

Identifier Type: -

Identifier Source: org_study_id

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