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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