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/NCT03141762




Registration number
NCT03141762
Ethics application status
Date submitted
10/04/2017
Date registered
5/05/2017

Titles & IDs
Public title
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
Scientific title
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
Secondary ID [1] 0 0
2016.365
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Falls calendar - number of falls per month for 12 months, self-recorded by participant
Timepoint [1] 0 0
One per month for 12 months
Secondary outcome [1] 0 0
Muscle ultrasound imaging
Timepoint [1] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [2] 0 0
Hand held dynamometry
Timepoint [2] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [3] 0 0
mini-BEST
Timepoint [3] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [4] 0 0
4 metre walk test
Timepoint [4] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [5] 0 0
MoCA
Timepoint [5] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [6] 0 0
Physical activity levels
Timepoint [6] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [7] 0 0
Clinical frailty scale questionairre
Timepoint [7] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [8] 0 0
Falls Risk for Older People in the Community Setting (FROP-com) Questionairre
Timepoint [8] 0 0
3, 6, and 12 months post discharge
Secondary outcome [9] 0 0
Fall efficacy scale questionnaire (version: FES-International short form)
Timepoint [9] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [10] 0 0
Hospital Anxiety and Depression Scale (HADS) Questionairre
Timepoint [10] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [11] 0 0
EuroQol five dimensions questionnaire (version: EQ-5D-5L)
Timepoint [11] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [12] 0 0
Impact of Event Scale questionnaire (version: IES-R)
Timepoint [12] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [13] 0 0
Short Physical Performance Battery
Timepoint [13] 0 0
Baseline, 3, 6, and 12 months post discharge
Secondary outcome [14] 0 0
Healthcare usage
Timepoint [14] 0 0
3, 6, and 12 months post discharge
Secondary outcome [15] 0 0
FACIT Fatigue Scale (in subgroup)
Timepoint [15] 0 0
3, 6 and 12 months
Secondary outcome [16] 0 0
Sedentary behaviour questionnaire (in subgroup)
Timepoint [16] 0 0
3, 6, and 12 months
Secondary outcome [17] 0 0
Conor Davidson Resilience Questionnaire (in subgroup)
Timepoint [17] 0 0
3, 6, and 12 months
Secondary outcome [18] 0 0
Life Orientation Revised Optimism Scale (in subgroup)
Timepoint [18] 0 0
3, 6, and 12 months
Secondary outcome [19] 0 0
Pittsburgh Sleep Quality Index (in subgroup)
Timepoint [19] 0 0
3, 6, and 12 months
Secondary outcome [20] 0 0
MYMOP2 (in subgroup)
Timepoint [20] 0 0
3, 6, and 12 months
Secondary outcome [21] 0 0
Memorial symptoms questionnaire short form
Timepoint [21] 0 0
3, 6, and 12 months
Secondary outcome [22] 0 0
Return to work
Timepoint [22] 0 0
3, 6 and 12 months

Eligibility
Key inclusion criteria
* hospitalised adults aged 18 years
* with an ICU admission requiring invasive mechanical ventilation for at least 48 hours and remain in ICU > 4 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant
* Insufficient English language skills to read and understand questionnaires and patient information consent form
* Pre-existing documented cognitive impairment
* Spinal cord injury or other primary neuromuscular disease or new brain injury
* Patient unable to be followed up due to geographic location
* New lower limb fracture on this admission
* Liver failure with abdominal distension due to ascites requiring fortnightly drainage
* Recent history of stroke or major surgery affecting lower limb e.g. Total knee or hip replacement in the past 12 weeks
* Neurological disorders such as Parkinson disease or multiple sclerosis
* Poor premorbid function defined as <10 metres ambulation +/- gait aid independently
* Frequent falls history defined as 3 or more falls over 2 months
* incarcerated or safety concerns for follow up
* discharged to palliative hospice facility
* not expected to survive to 3 months post hospital discharge
* unable to provide informed consent before hospital discharge due to current cognitive state (e.g. delirium, psychosis)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2020
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Kentucky
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Selina Parry, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Currently undecided if plan to make IPD available will update the Clinical Trials Registry.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03141762