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Prospective Registry of Mobilization-, Routine- and Outcome Data of Intensive Care Patients (MOBDB)

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ClinicalTrials.gov Identifier: NCT03666286
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
Stefan Schaller, Technical University of Munich

Study Description
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Brief Summary:
Registry database of intensive care patients. These data comprises of routine data including mobilization data and follow up assessments.

Condition or disease
Critical Care Rehabilitation Outcome Assessment (Health Care)

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective Registry of Mobilization-, Routine- and Outcome Data of Intensive Care Patients
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030
Groups and Cohorts
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Group/Cohort
Intensive Care Patients
Patients >24h on intensive care


Outcome Measures
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Primary Outcome Measures :
  1. Physical Function at hospital discharge [ Time Frame: At hospital discharge, on average within 1 month ]
    Physical function at ICU discharge with either the mmFIM (minimal modified Functional Independence Measure) or the Barthel subdomains transfer, locomotion and climbing stairs


Secondary Outcome Measures :
  1. Hospital Mortality [ Time Frame: At hospital discharge, on average within 1 month ]
    Hospital Mortality

  2. Pre-ICU Function [ Time Frame: 2 weeks before ICU admission ]
    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

  3. Global function of the patient [ Time Frame: 180 and 360 days after ICU discharge ]
    Global function of the patient assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule)

  4. Physical function of the patient [ Time Frame: 180 and 360 days after ICU discharge ]
    Physical function of the patient assessed with the IADL (The Lawton Instrumental Activities of Daily Living)

  5. Quality of Life of the patient [ Time Frame: 180 and 360 days after ICU discharge ]
    Quality of Life of the patient assessed with the EQ5D (European Quality of Life 5 Dimensions 5 Level)

  6. Cognitive Function [ Time Frame: 180 and 360 days after ICU discharge ]
    Cognitive Function assessed with the MoCA blind (Montreal Cognitive Assessment)

  7. Anxiety and Depression [ Time Frame: 180 and 360 days after ICU discharge ]
    Anxiety and Depression assessed with the IES-R (Impact of Event Scale - Revised) and HADS (Hospital Anxiety and Depression scale)

  8. Return to work [ Time Frame: 180 and 360 days after ICU discharge ]
    Return to work assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule)

  9. ICU Mortality [ Time Frame: At ICU Discharge, on average within 2 weeks ]
    ICU Mortality

  10. Physical function at ICU discharge [ Time Frame: At ICU Discharge, on average within 2 weeks ]
    Physical function at ICU discharge with either the mmFIM (minimal modified Functional Independence Measure) or the Barthel subdomains transfer, locomotion and climbing stairs


Other Outcome Measures:
  1. Disability-Free survival [ Time Frame: 180 and 360 days after ICU discharge ]
    Disability-Free survival


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Sampling Method:   Probability Sample
Study Population
Intensive Care Unit Patients
Criteria

Inclusion Criteria:

  • Intensive care unit stay > 24 hours

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666286


Locations
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Germany
Klinikum rechts der Isar der TUM
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technical University of Munich
Investigators
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Principal Investigator: Stefan J Schaller, MD Technical University of Munich
More Information
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Additional Information:

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Responsible Party: Stefan Schaller, Senior Specialist Intensive Care, Technical University of Munich
ClinicalTrials.gov Identifier: NCT03666286    
Other Study ID Numbers: MOBDB
DRKS00011576 ( Registry Identifier: German Clinical Trials Register )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Sharing of anonymous data might be possible on reasonable scientific request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan Schaller, Technical University of Munich:
early mobilization, intensive care, longterm outcomes