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| Name | Class |
|---|---|
| Melbourne Health | OTHER |
| University of Kentucky | OTHER |
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Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible participants will include: hospitalised adults aged 18 years and above with an ICU admission requiring invasive mechanical ventilation for at least 48 hours.
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| Name | Affiliation | Role |
|---|---|---|
| Selina Parry, PhD | University of Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UK Healthcare | Lexington | Kentucky | 40536 | United States | ||
| Melbourne Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41052427 | Derived | Parry SM, Soh SE, Morris PE, Larkin JS, Hosey MM, Da Silva AA, Alexander EK, Wells M, Elsegood NK, Kinnersly EG, Beach LJ, Mayer KP, Oliveira CC, McGinley JL, Puthucheary Z, Denehy L, Granger CL. "From the moment I started standing again, I was worried about falls": fear of falling in intensive care unit survivors over 12 months. Ann Am Thorac Soc. 2026 Mar 1;23(3):397-408. doi: 10.1513/AnnalsATS.202503-314OC. |
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Currently undecided if plan to make IPD available will update the Clinical Trials Registry.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| Melbourne |
| Victoria |
| Australia |