Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study

Study Overview
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Brief Summary
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Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study

Detailed Description
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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.

Official Title
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Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study

Conditions
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Critical Illness

Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls calendar - number of falls per month for 12 months, self-recorded by participant | 12-monthly falls calendar - This will record time to first fall, falls, incidence, number of falls including injurious falls. | One per month for 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle ultrasound imaging | Ultrasound of rectus femoris and tibialis anterior | Baseline, 3, 6, and 12 months post discharge | 
| Hand held dynamometry | Muscle strength | Baseline, 3, 6, and 12 months post discharge | 
| mini-BEST | Balance | Baseline, 3, 6, and 12 months post discharge | 
| 4 metre walk test | Gait | Baseline, 3, 6, and 12 months post discharge | 
| MoCA | Cognitive | Baseline, 3, 6, and 12 months post discharge | 
| Physical activity levels | Physical activity as measured as per title. Assessed using a physical activity tracker that participants will wear. | Baseline, 3, 6, and 12 months post discharge | 
| Clinical frailty scale questionairre | Frailty | Baseline, 3, 6, and 12 months post discharge | 
| Falls Risk for Older People in the Community Setting (FROP-com) Questionairre | Falls risk | 3, 6, and 12 months post discharge | 
| Fall efficacy scale questionnaire (version: FES-International short form) | Individuals are asked to rate, on a four-point Likert scale, their concerns about the possibility of falling when performing 16 activities. | Baseline, 3, 6, and 12 months post discharge | 
| Hospital Anxiety and Depression Scale (HADS) Questionairre | It is a self-rating scale that measures anxiety and depression in both hospital and community settings. | Baseline, 3, 6, and 12 months post discharge | 
| EuroQol five dimensions questionnaire (version: EQ-5D-5L) | Self-reported health-related quality of life questionnaire. | Baseline, 3, 6, and 12 months post discharge | 
| Impact of Event Scale questionnaire (version: IES-R) | It is a self-reported questionnaire that measures It measures the severity of intrusion, avoidance, and hypervigilance symptoms, experienced over the past week. | Baseline, 3, 6, and 12 months post discharge | 
| Short Physical Performance Battery | physical test evaluation of balance, strength, and walking ability | Baseline, 3, 6, and 12 months post discharge | 
| Healthcare usage | Categorise readmissions and what health services are used post hospital discharge | 3, 6, and 12 months post discharge | 
| FACIT Fatigue Scale (in subgroup) | Fatigue levels self report questionnaire | 3, 6 and 12 months | 
| Sedentary behaviour questionnaire (in subgroup) | Weekend and weekday questionnaire of sedentary behaviour in hours | 3, 6, and 12 months | 
| Conor Davidson Resilience Questionnaire (in subgroup) | self report resilience questionnaire | 3, 6, and 12 months | 
| Life Orientation Revised Optimism Scale (in subgroup) | 10 item self report optimism scale, higher scores indicate higher optimism | 3, 6, and 12 months | 
| Pittsburgh Sleep Quality Index (in subgroup) | questionnaire that evaluates sleep quality, higher scores indicate poorer sleep | 3, 6, and 12 months | 
| MYMOP2 (in subgroup) | short questionnaire which asks patients to rate their top problems and activity limitations | 3, 6, and 12 months | 
| Memorial symptoms questionnaire short form | questionnaire which covers different symptoms and how much it bothers the patient on a likert scale | 3, 6, and 12 months | 
| Return to work | questionnaire which provides time to return to work and impact on finances | 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, Intensive care