Critical IllnessASTONNCT03785444
Comparison of Self-assessment vs. Assessment by Others of Critically Ill Patients
An observational study of Critical Illness and Self-Assessment, run by Technical University of Munich at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Self-Assessment, Assessment, Self
- What is being tested?
- WHODAS 2.0, EQ5D and IADL
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Feb 2019to 15 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients with a high risk to be admitted to intensive care
Who may be able to join
- patient with a postoperative risk to be admitted to intensive care
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité - Universitätsmedizin Berlin
Berlin, 13353
Klinikum rechts der Isar, School of Medicine, Technical University of Munich
Munich, Bavaria, 81675
About this study
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)
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
- Being tested
- WHODAS 2.0, EQ5D, IADL, Barthel-Score, SF-36
- Keywords
- Assessment by others, Self-Assessment, Critically ill, Intensive care, standardized questionnaire, functional status, WHODAS, EQ5D, IADL, Barthel Score, SF-36, MoCA Blind
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHODAS 2.0Other
WHO Disability Score
EQ5DOther
Health related quality of life measured with European Quality of Life 5 Dimensions 5 Level
IADLOther
The Lawton Instrumental Activities of Daily Living
Barthel-ScoreOther
Barthel Score of the patient
SF-36Other
Short Form Health 36
MoCA BlindOther
Montreal Cognitive Assessment
| Study group | Role | What they receive |
|---|---|---|
| Intensive Care Patients | Postoperative patients who have been admitted to intensive care Receives: 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 Receives: Other: WHODAS 2.0; Other: EQ5D; Other: IADL; Other: Barthel-Score; Other: SF-36; Other: MoCA Blind |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks before hospital admission
Secondary outcomes (3)
Agreement in assessment of ICU vs. non-ICU patients
Comparison of results of assessment of questionnaires of ICU patients vs. non-ICU patients
Measured: 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
Measured: 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
Measured: 2 weeks before hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start25 Feb 2019
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion
- Responsible party
- Sponsor
- Investigators
- Stefan J Schaller, MD, Principal investigator, Technical University of MunichSteffen Weber-Carstens, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785444
- Sponsor's protocol ID
- ASTON
- Acronym
- ASTON
- Status last verified
- Oct 2020
- First submitted
- 17 Dec 2018
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 40390142
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03785444
- Acronym / sponsor ID
- ASTON / ASTON
- Conditions
- Critical Illness, Self-Assessment, Assessment, Self
- Keywords
- Assessment by others, Self-Assessment, Critically ill, Intensive care, standardized questionnaire, functional status, WHODAS, EQ5D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Care Patients | – | Other: WHODAS 2.0, Other: EQ5D, Other: IADL, Other: Barthel-Score, Other: SF-36, Other: MoCA BlindPostoperative patients who have been admitted to intensive care |
| Non-Intensive Care Patients | – | Other: WHODAS 2.0, Other: EQ5D, Other: IADL, Other: Barthel-Score, Other: SF-36, Other: MoCA BlindPostoperative patients who have not been admitted to intensive care but to the normal ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients with a high risk to be admitted to intensive care
Key inclusion criteria (2 listed)
- patient with a postoperative risk to be admitted to intensive care
- signed informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHODAS 2.0WHO Disability Score | Other | Intensive Care Patients, Non-Intensive Care Patients |
| EQ5DHealth related quality of life measured with European Quality of Life 5 Dimensions 5 Level | Other | Intensive Care Patients, Non-Intensive Care Patients |
| IADLThe Lawton Instrumental Activities of Daily Living | Other | Intensive Care Patients, Non-Intensive Care Patients |
| Barthel-ScoreBarthel Score of the patient | Other | Intensive Care Patients, Non-Intensive Care Patients |
| SF-36Short Form Health 36 | Other | Intensive Care Patients, Non-Intensive Care Patients |
| MoCA BlindMontreal Cognitive Assessment | Other | Intensive Care Patients, Non-Intensive Care Patients |
Primary outcome
Agreement in assessment of ICU patients
Time frame: 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
3 secondary outcomes
Agreement in assessment of ICU vs. non-ICU patients
Time frame: 2 weeks before hospital admission
Agreement in assessment of non-ICU patients
Time frame: 2 weeks before hospital admission
Multivariate testing using the closeness of the relationship
Time frame: 2 weeks before hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 40390142Grunow 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.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan J Schaller, MD principal investigator
Technical University of Munich
Steffen Weber-Carstens, MD principal investigator
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Self-Assessment, run by Technical University of Munich at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in assessment of ICU patients (time frame: 2 weeks before hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.