Prospective Registry of Mobilization-, Routine- and Outcome Data of Intensive Care Patients (MOBDB)
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Registry database of intensive care patients. These data comprises of routine data including mobilization data and follow up assessments.
The database is supposed to help quality improvement as well as
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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Bavaria
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Munich, Bavaria, Germany, 81675
- Klinikum rechts der Isar der TUM
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Intensive care unit stay > 24 hours
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
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Intensive Care Patients
Patients >24h on intensive care
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Function at hospital discharge
Time Frame: At hospital discharge, on average within 1 month
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Physical function at ICU discharge with either the mmFIM (minimal modified Functional Independence Measure) or the Barthel subdomains transfer, locomotion and climbing stairs
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At hospital discharge, on average within 1 month
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Mortality
Time Frame: At hospital discharge, on average within 1 month
|
Hospital Mortality
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At hospital discharge, on average within 1 month
|
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Pre-ICU Function
Time Frame: 2 weeks before ICU admission
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Pre-ICU Function assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule), EQ5D (European Quality of Life 5 Dimensions 5 Level) and work details
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2 weeks before ICU admission
|
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Global function of the patient
Time Frame: 180 and 360 days after ICU discharge
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Global function of the patient assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule)
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180 and 360 days after ICU discharge
|
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Physical function of the patient
Time Frame: 180 and 360 days after ICU discharge
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Physical function of the patient assessed with the IADL (The Lawton Instrumental Activities of Daily Living)
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180 and 360 days after ICU discharge
|
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Quality of Life of the patient
Time Frame: 180 and 360 days after ICU discharge
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Quality of Life of the patient assessed with the EQ5D (European Quality of Life 5 Dimensions 5 Level)
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180 and 360 days after ICU discharge
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Cognitive Function
Time Frame: 180 and 360 days after ICU discharge
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Cognitive Function assessed with the MoCA blind (Montreal Cognitive Assessment)
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180 and 360 days after ICU discharge
|
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Anxiety and Depression
Time Frame: 180 and 360 days after ICU discharge
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Anxiety and Depression assessed with the IES-R (Impact of Event Scale - Revised) and HADS (Hospital Anxiety and Depression scale)
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180 and 360 days after ICU discharge
|
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Return to work
Time Frame: 180 and 360 days after ICU discharge
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Return to work assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule)
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180 and 360 days after ICU discharge
|
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ICU Mortality
Time Frame: At ICU Discharge, on average within 2 weeks
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ICU Mortality
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At ICU Discharge, on average within 2 weeks
|
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Physical function at ICU discharge
Time Frame: At ICU Discharge, on average within 2 weeks
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Physical function at ICU discharge with either the mmFIM (minimal modified Functional Independence Measure) or the Barthel subdomains transfer, locomotion and climbing stairs
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At ICU Discharge, on average within 2 weeks
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability-Free survival
Time Frame: 180 and 360 days after ICU discharge
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Disability-Free survival
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180 and 360 days after ICU discharge
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Stefan J Schaller, MD, Technical University of Munich
Publications and helpful links
General Publications
- Lorenz M, Fuest K, Ulm B, Grunow JJ, Warner L, Bald A, Arsene V, Verfuss M, Daum N, Blobner M, Schaller SJ. The optimal dose of mobilisation therapy in the ICU: a prospective cohort study. J Intensive Care. 2023 Nov 20;11(1):56. doi: 10.1186/s40560-023-00703-1.
- Fuest KE, Ulm B, Daum N, Lindholz M, Lorenz M, Blobner K, Langer N, Hodgson C, Herridge M, Blobner M, Schaller SJ. Clustering of critically ill patients using an individualized learning approach enables dose optimization of mobilization in the ICU. Crit Care. 2023 Jan 3;27(1):1. doi: 10.1186/s13054-022-04291-8.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- MOBDB
- DRKS00011576 (Registry Identifier: German Clinical Trials Register)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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