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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03141762
Registration number
NCT03141762
Ethics application status
Date submitted
10/04/2017
Date registered
5/05/2017
Date last updated
28/12/2023
Titles & IDs
Public title
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
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Scientific title
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
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Secondary ID [1]
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2016.365
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Falls calendar - number of falls per month for 12 months, self-recorded by participant
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Assessment method [1]
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12-monthly falls calendar - This will record time to first fall, falls, incidence, number of falls including injurious falls.
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Timepoint [1]
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One per month for 12 months
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Secondary outcome [1]
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Muscle ultrasound imaging
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Assessment method [1]
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Ultrasound of rectus femoris and tibialis anterior
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Timepoint [1]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [2]
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Hand held dynamometry
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Assessment method [2]
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Muscle strength
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Timepoint [2]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [3]
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mini-BEST
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Assessment method [3]
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Balance
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Timepoint [3]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [4]
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4 metre walk test
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Assessment method [4]
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Gait
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Timepoint [4]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [5]
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MoCA
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Assessment method [5]
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Cognitive
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Timepoint [5]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [6]
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Physical activity levels
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Assessment method [6]
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Physical activity as measured as per title. Assessed using a physical activity tracker that participants will wear.
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Timepoint [6]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [7]
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Clinical frailty scale questionairre
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Assessment method [7]
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Frailty
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Timepoint [7]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [8]
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Falls Risk for Older People in the Community Setting (FROP-com) Questionairre
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Assessment method [8]
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Falls risk
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Timepoint [8]
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3, 6, and 12 months post discharge
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Secondary outcome [9]
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Fall efficacy scale questionnaire (version: FES-International short form)
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Assessment method [9]
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Individuals are asked to rate, on a four-point Likert scale, their concerns about the possibility of falling when performing 16 activities.
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Timepoint [9]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [10]
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Hospital Anxiety and Depression Scale (HADS) Questionairre
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Assessment method [10]
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It is a self-rating scale that measures anxiety and depression in both hospital and community settings.
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Timepoint [10]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [11]
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EuroQol five dimensions questionnaire (version: EQ-5D-5L)
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Assessment method [11]
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Self-reported health-related quality of life questionnaire.
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Timepoint [11]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [12]
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Impact of Event Scale questionnaire (version: IES-R)
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Assessment method [12]
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It is a self-reported questionnaire that measures It measures the severity of intrusion, avoidance, and hypervigilance symptoms, experienced over the past week.
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Timepoint [12]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [13]
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Short Physical Performance Battery
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Assessment method [13]
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physical test evaluation of balance, strength, and walking ability
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Timepoint [13]
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Baseline, 3, 6, and 12 months post discharge
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Secondary outcome [14]
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Healthcare usage
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Assessment method [14]
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Categorise readmissions and what health services are used post hospital discharge
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Timepoint [14]
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3, 6, and 12 months post discharge
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Secondary outcome [15]
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FACIT Fatigue Scale (in subgroup)
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Assessment method [15]
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Fatigue levels self report questionnaire
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Timepoint [15]
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3, 6 and 12 months
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Secondary outcome [16]
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Sedentary behaviour questionnaire (in subgroup)
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Assessment method [16]
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Weekend and weekday questionnaire of sedentary behaviour in hours
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Timepoint [16]
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3, 6, and 12 months
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Secondary outcome [17]
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Conor Davidson Resilience Questionnaire (in subgroup)
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Assessment method [17]
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self report resilience questionnaire
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Timepoint [17]
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3, 6, and 12 months
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Secondary outcome [18]
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Life Orientation Revised Optimism Scale (in subgroup)
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Assessment method [18]
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10 item self report optimism scale, higher scores indicate higher optimism
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Timepoint [18]
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3, 6, and 12 months
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Secondary outcome [19]
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Pittsburgh Sleep Quality Index (in subgroup)
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Assessment method [19]
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questionnaire that evaluates sleep quality, higher scores indicate poorer sleep
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Timepoint [19]
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3, 6, and 12 months
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Secondary outcome [20]
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MYMOP2 (in subgroup)
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Assessment method [20]
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short questionnaire which asks patients to rate their top problems and activity limitations
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Timepoint [20]
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3, 6, and 12 months
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Secondary outcome [21]
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Memorial symptoms questionnaire short form
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Assessment method [21]
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questionnaire which covers different symptoms and how much it bothers the patient on a likert scale
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Timepoint [21]
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3, 6, and 12 months
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Secondary outcome [22]
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Return to work
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Assessment method [22]
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questionnaire which provides time to return to work and impact on finances
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Timepoint [22]
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3, 6 and 12 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/09/2020
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne Health - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Kentucky
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Melbourne Health
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Kentucky
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03141762
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Selina Parry, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03141762
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