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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

More Details

NCT ID
NCT03141762
Status
Recruiting
Sponsor
University of Melbourne

Study Contact

Selina Parry, PhD
61383444171
selina.parry@unimelb.edu.au

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. It is a multicentre study over three sites: UK Healthcare, Melbourne Health and Austin Health. All adult patients in intensive care that have been mechanically ventilated for over 24 hours, and remain in the ICU more than 4 days will be considerer 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.