Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
151 participants
OBSERVATIONAL
2015-08-31
2017-08-31
Brief Summary
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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.
Detailed Description
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Phase 1: Two outcome measures - PFIT-s and DEMMI will be performed within 24 hour period. Order of testing will be randomised to minimise testing bias. Time-points of assessment are: awakening, ICU discharge and hospital discharge. Weekly measures will also be performed if required in ICU and/or ward settings for up to a maximum of 30 days in each setting. The measurement properties of the individual tools PFIT-s and DEMMI will be examined (e.g. validity, responsiveness).
Phase 2: Based on the findings in Phase 1 a new single outcome measure will be developed. In the second phase examination of the measurement properties of the tool will be undertaken including (reliability, validity, responsiveness).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Mechanically ventilated \> 48 hours
* Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait aid)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Melbourne Health
OTHER
Flinders Medical Centre
OTHER_GOV
National University Hospital, Singapore
OTHER
Escola Superior da Saude, Brazil
UNKNOWN
University of Melbourne
OTHER
Responsible Party
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Selina M Parry
Dr, PhD, Grad Cert Uni Teaching, B.Physio (Hons)
Principal Investigators
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Dr Selina M Parry, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Locations
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University of South Australia and Flinders Medical Centre
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Escola superior de ciências da saúde ESCS
Brazil, , Brazil
National University Hospital
Singapore, , Singapore
Countries
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References
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Parry SM, Granger CL, Berney S, Jones J, Beach L, El-Ansary D, Koopman R, Denehy L. Assessment of impairment and activity limitations in the critically ill: a systematic review of measurement instruments and their clinimetric properties. Intensive Care Med. 2015 May;41(5):744-62. doi: 10.1007/s00134-015-3672-x. Epub 2015 Feb 5.
Parry SM, Denehy L, Beach LJ, Berney S, Williamson HC, Granger CL. Functional outcomes in ICU - what should we be using? - an observational study. Crit Care. 2015 Mar 29;19(1):127. doi: 10.1186/s13054-015-0829-5.
Other Identifiers
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2015026
Identifier Type: -
Identifier Source: org_study_id