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

Rehabilitation Clinical Trial

— MOBDB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03666286
• Other study ID #: MOBDB
• Secondary ID: DRKS00011576
• Status: Active, not recruiting
• Start date: February 1, 2017
• Est. completion date: December 31, 2030

Study information

• Verified date: November 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Intensive care unit stay > 24 hours

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Critical Care
• Outcome Assessment (Health Care)
• Rehabilitation

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar der TUM	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disability-Free survival	Disability-Free survival	180 and 360 days after ICU discharge
Primary	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	Hospital Mortality	Hospital Mortality	At hospital discharge, on average within 1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cognitive Function	Cognitive Function assessed with the MoCA blind (Montreal Cognitive Assessment)	180 and 360 days after ICU discharge
Secondary	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
Secondary	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
Secondary	ICU Mortality	ICU Mortality	At ICU Discharge, on average within 2 weeks
Secondary	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