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

NCT03141762 | Completed DMC

• 1 other identifier: 2016.365
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Critical Illness

Keywords

Falls; Intensive care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Muscle ultrasound imaging

  Baseline, 3, 6, and 12 months post discharge

• Hand held dynamometry

  Baseline, 3, 6, and 12 months post discharge

• mini-BEST

  Baseline, 3, 6, and 12 months post discharge

• 4 metre walk test

  Baseline, 3, 6, and 12 months post discharge

• MoCA

  Baseline, 3, 6, and 12 months post discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible participants will include: hospitalised adults aged 18 years and above with an ICU admission requiring invasive mechanical ventilation for at least 48 hours.

You may qualify if:

• hospitalised adults aged 18 years
• with an ICU admission requiring invasive mechanical ventilation for at least 48 hours and remain in ICU \> 4 days

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Melbourne: lead
• Melbourne Health: collaborator
• University of Kentucky: collaborator

Study Sites (2)

UK Healthcare

Lexington, Kentucky, 40536, United States

Location

Melbourne Health

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Selina Parry, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: May 5, 2017
• Study Start: May 3, 2017
• Primary Completion: September 20, 2020
• Study Completion: September 20, 2020
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

US (1); AU (1)