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

Registry database of intensive care patients. These data comprises of routine data including mobilization data and follow up assessments.

Study Overview

• Status: Active, not recruiting
• Conditions: Rehabilitation; Critical Care; 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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar der TUM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Intensive Care Unit Patients

Description

Inclusion Criteria:

• Intensive care unit stay > 24 hours

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intensive Care Patients; Patients >24h on intensive care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality	Hospital Mortality	At hospital discharge, on average within 1 month
Pre-ICU Function	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	2 weeks before ICU admission
Global function of the patient	Global function of the patient assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule)	180 and 360 days after ICU discharge
Physical function of the patient	Physical function of the patient assessed with the IADL (The Lawton Instrumental Activities of Daily Living)	180 and 360 days after ICU discharge
Quality of Life of the patient	Quality of Life of the patient assessed with the EQ5D (European Quality of Life 5 Dimensions 5 Level)	180 and 360 days after ICU discharge
Cognitive Function	Cognitive Function assessed with the MoCA blind (Montreal Cognitive Assessment)	180 and 360 days after ICU discharge
Anxiety and Depression	Anxiety and Depression assessed with the IES-R (Impact of Event Scale - Revised) and HADS (Hospital Anxiety and Depression scale)	180 and 360 days after ICU discharge
Return to work	Return to work assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule)	180 and 360 days after ICU discharge
ICU Mortality	ICU Mortality	At ICU Discharge, on average within 2 weeks
Physical function at ICU discharge	Physical function at ICU discharge with either the mmFIM (minimal modified Functional Independence Measure) or the Barthel subdomains transfer, locomotion and climbing stairs	At ICU Discharge, on average within 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability-Free survival	Disability-Free survival	180 and 360 days after ICU discharge

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Stefan J Schaller, MD, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: early mobilization, intensive care, longterm outcomes
• 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)?: UNDECIDED
• IPD Plan Description: Sharing of anonymous data might be possible on reasonable scientific request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No