Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
- Conditions
- Critical Illness
- Registration Number
- NCT03141762
- Lead Sponsor
- University of Melbourne
- Brief Summary
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
- Detailed Description
This observational study aims to investigate the incidence and risk factors for falls in the first 12 months post hospital discharge in patients following an ICU admission. It also aims to determine factors at hospital discharge which may predict future falls risk at 12 months and examine the physical activity levels of ICU survivors. Furthermore, it also will investigate the relationship between falls, fear of falling and activity limitations and participation restriction. All adult patients in intensive care that have been mechanically ventilated for over 48 hours, and remain in the ICU at least 4 days will be considered for inclusion. The primary outcome measure is a 12 month falls diary which commences on hospital discharge. There will also be Physiotherapy assessments just prior to hospital discharge, 3, 6, and 12 months post hospital discharge.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- hospitalised adults aged 18 years
- with an ICU admission requiring invasive mechanical ventilation for at least 48 hours and remain in ICU > 4 days
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Falls calendar - number of falls per month for 12 months, self-recorded by participant One per month for 12 months 12-monthly falls calendar - This will record time to first fall, falls, incidence, number of falls including injurious falls.
- Secondary Outcome Measures
Name Time Method Muscle ultrasound imaging Baseline, 3, 6, and 12 months post discharge Ultrasound of rectus femoris and tibialis anterior
Hand held dynamometry Baseline, 3, 6, and 12 months post discharge Muscle strength
4 metre walk test Baseline, 3, 6, and 12 months post discharge Gait
Falls Risk for Older People in the Community Setting (FROP-com) Questionairre 3, 6, and 12 months post discharge Falls risk
MYMOP2 (in subgroup) 3, 6, and 12 months short questionnaire which asks patients to rate their top problems and activity limitations
Return to work 3, 6 and 12 months questionnaire which provides time to return to work and impact on finances
mini-BEST Baseline, 3, 6, and 12 months post discharge Balance
MoCA Baseline, 3, 6, and 12 months post discharge Cognitive
Physical activity levels Baseline, 3, 6, and 12 months post discharge Physical activity as measured as per title. Assessed using a physical activity tracker that participants will wear.
Clinical frailty scale questionairre Baseline, 3, 6, and 12 months post discharge Frailty
Impact of Event Scale questionnaire (version: IES-R) Baseline, 3, 6, and 12 months post discharge It is a self-reported questionnaire that measures It measures the severity of intrusion, avoidance, and hypervigilance symptoms, experienced over the past week.
Short Physical Performance Battery Baseline, 3, 6, and 12 months post discharge physical test evaluation of balance, strength, and walking ability
Hospital Anxiety and Depression Scale (HADS) Questionairre Baseline, 3, 6, and 12 months post discharge It is a self-rating scale that measures anxiety and depression in both hospital and community settings.
Fall efficacy scale questionnaire (version: FES-International short form) Baseline, 3, 6, and 12 months post discharge Individuals are asked to rate, on a four-point Likert scale, their concerns about the possibility of falling when performing 16 activities.
Healthcare usage 3, 6, and 12 months post discharge Categorise readmissions and what health services are used post hospital discharge
EuroQol five dimensions questionnaire (version: EQ-5D-5L) Baseline, 3, 6, and 12 months post discharge Self-reported health-related quality of life questionnaire.
FACIT Fatigue Scale (in subgroup) 3, 6 and 12 months Fatigue levels self report questionnaire
Sedentary behaviour questionnaire (in subgroup) 3, 6, and 12 months Weekend and weekday questionnaire of sedentary behaviour in hours
Conor Davidson Resilience Questionnaire (in subgroup) 3, 6, and 12 months self report resilience questionnaire
Life Orientation Revised Optimism Scale (in subgroup) 3, 6, and 12 months 10 item self report optimism scale, higher scores indicate higher optimism
Pittsburgh Sleep Quality Index (in subgroup) 3, 6, and 12 months questionnaire that evaluates sleep quality, higher scores indicate poorer sleep
Memorial symptoms questionnaire short form 3, 6, and 12 months questionnaire which covers different symptoms and how much it bothers the patient on a likert scale
Trial Locations
- Locations (2)
Melbourne Health
🇦🇺Melbourne, Victoria, Australia
UK Healthcare
🇺🇸Lexington, Kentucky, United States