Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03226912
Registration number
NCT03226912
Ethics application status
Date submitted
17/07/2017
Date registered
24/07/2017
Titles & IDs
Public title
The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
Query!
Scientific title
The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
Query!
Secondary ID [1]
0
0
ANZIC-RC/CH002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PREDICT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Critical Illness
0
0
Query!
Mechanical Ventilation Complication
0
0
Query!
Disabilities Multiple
0
0
Query!
Quality of Life
0
0
Query!
Physical Disability
0
0
Query!
Anxiety
0
0
Query!
Depression
0
0
Query!
Cognitive Change
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)
Query!
Assessment method [1]
0
0
Development of a risk-prediction model for disability-free survival in high risk patients (after \> 24 hours of mechanical ventilation)
Query!
Timepoint [1]
0
0
3-6 months post ICU admission
Query!
Secondary outcome [1]
0
0
Health related quality of life (HRQOL)
Query!
Assessment method [1]
0
0
Health related quality of life (HRQOL) measured with EQ5D before ICU
Query!
Timepoint [1]
0
0
3-6 months post ICU admission
Query!
Secondary outcome [2]
0
0
Pre ICU health status
Query!
Assessment method [2]
0
0
pre ICU health status measured by retrospective EQ5D
Query!
Timepoint [2]
0
0
3 months post ICU admission
Query!
Secondary outcome [3]
0
0
Global function
Query!
Assessment method [3]
0
0
Global function measured with the WHODAS
Query!
Timepoint [3]
0
0
3-6 months post ICU admission
Query!
Secondary outcome [4]
0
0
Physical activity at 6 months
Query!
Assessment method [4]
0
0
Physical activity at 6 months measured with the IADL
Query!
Timepoint [4]
0
0
6 months post ICU admission
Query!
Secondary outcome [5]
0
0
Cognitive function at 6 months
Query!
Assessment method [5]
0
0
Cognetive function measured using the MOCA blind
Query!
Timepoint [5]
0
0
6 months post ICU admission
Query!
Secondary outcome [6]
0
0
Anxiety and depression at 6 months will be assessed
Query!
Assessment method [6]
0
0
Anxiety and depression at 6 months will be assessed with the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES-R)
Query!
Timepoint [6]
0
0
6 months post ICU admission
Query!
Secondary outcome [7]
0
0
Return to work at 3 and 6 months
Query!
Assessment method [7]
0
0
Return to work at 3 and 6 months will be measured using extra questions
Query!
Timepoint [7]
0
0
3-6 months post ICU admission
Query!
Secondary outcome [8]
0
0
Pre ICU disability and work status
Query!
Assessment method [8]
0
0
Pre ICU disability and work status measured using the WHODAS
Query!
Timepoint [8]
0
0
3 months post ICU admission
Query!
Eligibility
Key inclusion criteria
* ICU patients who have been mechanically ventilated for over 24 hours
* Patients 18 years or older
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* A Proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. TBI, SAH, stroke or hypoxic brain injury after cardiac arrest)
* Second or subsequent admission to ICU during a single hospital admission
* Participants who do not speak English
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/07/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/03/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
500
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Australian New Zealand Intensive Care Reseearch Centre - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3004 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Australian and New Zealand Intensive Care Research Centre
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
National Health and Medical Research Council, Australia
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
As mortality from critical illness has reduced, the importance of measuring disabilities (cognitive, functional and psychological) in surviving critically ill patients has become more important. Currently, the causes, long-term effects and frequency of disabilities in patients surviving ICU in Australia are unknown. In the US and UK, studies have been undertaken to assess the effects of specific long-term outcomes, such as functional disability and depression, which found long-term disabilities were much higher than baselines (pre-illness function) and ongoing at five years after ICU discharge. In order to improve quality of life of ICU survivors and ensure that medical specialists apply appropriate interventions to reduce the cost of these surviving patients on the community, the PREDICT management committee proposes the introduction of a patient-reported outcomes registry.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03226912
Query!
Trial related presentations / publications
Higgins AM, Neto AS, Bailey M, Barrett J, Bellomo R, Cooper DJ, Gabbe BJ, Linke N, Myles PS, Paton M, Philpot S, Shulman M, Young M, Hodgson CL; PREDICT Study Investigators. Predictors of death and new disability after critical illness: a multicentre prospective cohort study. Intensive Care Med. 2021 Jul;47(7):772-781. doi: 10.1007/s00134-021-06438-7. Epub 2021 Jun 5. Hodgson CL, Higgins AM, Bailey M, Barrett J, Bellomo R, Cooper DJ, Gabbe BJ, Iwashyna T, Linke N, Myles PS, Paton M, Philpot S, Shulman M, Young M, Serpa Neto A; PREDICT Study Investigators. Comparison of 6-month outcomes of sepsis versus non-sepsis critically ill patients receiving mechanical ventilation. Crit Care. 2022 Jun 13;26(1):174. doi: 10.1186/s13054-022-04041-w.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Higgins AM, Neto AS, Bailey M, Barrett J, Bellomo ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT03226912