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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02911896
Registration number
NCT02911896
Ethics application status
Date submitted
25/07/2016
Date registered
22/09/2016
Date last updated
30/10/2017
Titles & IDs
Public title
Physical Function in Critical Care (PaciFIC)
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Scientific title
Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study
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Secondary ID [1]
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2015026
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Universal Trial Number (UTN)
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Trial acronym
PaciFIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intensive Care (ICU) Myopathy
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Physical Function in Intensive Care Test scored (PFIT-s) and De Morton Mobility Index from ICU awakening to hospital discharge
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Assessment method [1]
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Both measures are primary - there will be a single measure developed as composite in line with aims of this observational study
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Timepoint [1]
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Baseline to hospital discharge (up to 3 months)
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Eligibility
Key inclusion criteria
- Adults > 18 years of age
- Mechanically ventilated > 48 hours
- Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait
aid)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Premorbid physical or cognitive impairment which would prevent ability to perform
functional measures
- New neurological impairment such as stroke or spinal cord injury
- Trauma or orthopaedic injury requiring period of immobilization or non weight bearing
status
- Traumatic brain injury with focal neurology
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2017
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Sample size
Target
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Accrual to date
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Final
151
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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University of South Australia and Flinders Medical Centre - Adelaide
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Recruitment hospital [2]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Brazil
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Country [2]
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Singapore
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State/province [2]
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Singapore
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Melbourne Health
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Flinders Medical Centre
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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National University Hospital, Singapore
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Escola Superior da Saude, Brazil
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
Impairment in physical function is a significant problem for survivors of critical illness.
There is a growing urgency to develop a core set of outcome measures, which can be adopted in
clinical and research practice to evaluate efficacy in response to interventions such as
rehabilitation.
Phase 1: Development of a new outcome measure. This study aims to examine the development of
a single outcome measure which may be able to be utilised across the continuum of recovery of
critical illness in the evaluation of physical function. The study will involve examination
of two common physical function measures - the Physical Function in intensive care test
scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new measure
based on rasch principles which may be able to capture physical functioning changes in
individuals with critical illness. Aims: (1) To determine the clinical utility of two
physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital
admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single measure
to evaluate function in intensive care survivors using Rasch analytical principles.
Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an
independent validation sample.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02911896
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Selina M Parry, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02911896
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