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

Sponsor
Technische Universität München (Other)
Overall Status
Completed
CT.gov ID
NCT03785444
Collaborator
Charite University, Berlin, Germany (Other), Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion (Other)
200
2
17.6
100
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: WHODAS 2.0
  • Other: EQ5D
  • Other: IADL
  • Other: Barthel-Score
  • Other: SF-36
  • Other: MoCA Blind

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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)
Actual Study Start Date :
Feb 25, 2019
Actual Primary Completion Date :
Aug 15, 2020
Actual Study Completion Date :
Aug 15, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

Other Outcome Measures

  1. Definition of criteria which define an appropriate close relationship to receive a reliable test result [2 weeks before hospital admission]

    Test which closeness of relationship is sufficient to provide adequate test results compared with the patient's answers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinikum rechts der Isar, School of Medicine, Technical University of Munich Munich Bavaria Germany 81675
2 Charité - Universitätsmedizin Berlin Berlin Germany 13353

Sponsors and Collaborators

  • Technische Universität München
  • Charite University, Berlin, Germany
  • Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion

Investigators

  • Principal Investigator: Stefan J Schaller, MD, Technische Universität München
  • Principal Investigator: Steffen Weber-Carstens, MD, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT03785444
Other Study ID Numbers:
  • ASTON
First Posted:
Dec 24, 2018
Last Update Posted:
Oct 6, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Technische Universität München
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2020