Intensive Care (ICU) MyopathyPaciFICNCT02911896
Physical Function in Critical Care (PaciFIC)
An observational study of Intensive Care (ICU) Myopathy, run by University of Melbourne at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU) Myopathy
- How many people
- 151 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Aug 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults > 18 years of age
- Mechanically ventilated > 48 hours
- Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait aid)
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Australia2 sites
University of South Australia and Flinders Medical Centre
Adelaide, South Australia
Royal Melbourne Hospital
Melbourne, Victoria
About this study
Official title: Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study
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.
Read the detailed description
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).
- Conditions
- Intensive Care (ICU) Myopathy
- Keywords
- physical function, critical care
- Medical subject headings
- Muscular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to hospital discharge (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care (ICU) MyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health, Flinders Medical Centre, National University Hospital, Singapore, Escola Superior da Saude, Brazil
- Responsible party
- Principal investigator, Selina M Parry, University of Melbourne
- Investigators
- Dr Selina M Parry, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911896
- Sponsor's protocol ID
- 2015026
- Acronym
- PaciFIC
- Status last verified
- Oct 2017
- First submitted
- 25 Jul 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25652888Parry 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.
PubMed 25888469
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study
- ClinicalTrials.gov ID
- NCT02911896
- Acronym / sponsor ID
- PaciFIC / 2015026
- Conditions
- Intensive Care (ICU) Myopathy
- Keywords
- physical function, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Melbourne Health, Flinders Medical Centre, National University Hospital, Singapore, Escola Superior da Saude, Brazil
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults > 18 years of age
- Mechanically ventilated > 48 hours
- Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait aid)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Results publication: PubMed 25652888Parry 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.
- Results publication: PubMed 25888469Parry 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Selina M Parry, PhD principal investigator
University of Melbourne
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care (ICU) Myopathy, run by University of Melbourne at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, Brazil, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02911896, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.