Physical Function in Critical Care (PaciFIC)

NCT02911896 | Completed

• 1 other identifier: 2015026
• Study Type: observational
• Target: 151
• Locations: 3 countries
• Sites: 4

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.

Conditions

Intensive Care (ICU) Myopathy

Keywords

physical function; critical care

Outcome Measures

Primary Outcomes (1)

• Change in Physical Function in Intensive Care Test scored (PFIT-s) and De Morton Mobility Index from ICU awakening to hospital discharge

  Both measures are primary - there will be a single measure developed as composite in line with aims of this observational study

  Baseline to hospital discharge (up to 3 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multi-centre study conducted in four acute hospitals: Royal Melbourne Hospital, Melbourne, Australia; Flinders Medical Centre, Adelaide, Australia; Escola Superior da Saude, Brasilia, Brazil; and National University Hospital, Singapore.

You may qualify if:

• Adults \> 18 years of age
• Mechanically ventilated \> 48 hours
• Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait aid)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead
• Melbourne Health: collaborator
• Flinders Medical Centre: collaborator
• National University Hospital, Singapore: collaborator
• Escola Superior da Saude, Brazil: collaborator

Study Sites (4)

University of South Australia and Flinders Medical Centre

Adelaide, South Australia, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Location

Escola superior de ciências da saúde ESCS

Brazil, Brazil

Location

National University Hospital

Singapore, Singapore

Location

Related Publications (2)

• 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.

  PMID: 25652888 RESULT

• 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.

  PMID: 25888469 RESULT

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Dr Selina M Parry, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, PhD, Grad Cert Uni Teaching, B.Physio (Hons)

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: September 22, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

SG (1); AU (2); BR (1)