Physical Function in Critical Care (PaciFIC)

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.

Completed

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Key information

Conditions

Intensive Care (ICU) Myopathy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Australia and Flinders Medical Centre, Adelaide, South Australia, Australia

About this study

Consecutive eligible patients will be recruited into the study.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

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

Treatment and study plan

Primary outcomes

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

Time frame: Baseline to hospital discharge (up to 3 months)

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

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

Escola Superior da Saude, Brazil
Flinders Medical Centre
Melbourne Health
National University Hospital, Singapore

Registry information

Official study title

Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study

Acronym: PaciFIC

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Sep 22, 2016
Registry last updated: Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed