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

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

Study Overview

• Status: Completed
• Conditions: Critical Illness

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • Melbourne Health
• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • UK HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Melbourne
• Collaborators: Melbourne Health; University of Kentucky
• Investigators: Principal Investigator: Selina Parry, PhD, University of Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): September 20, 2020
• Study Completion (Actual): September 20, 2020

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intensive care; Falls
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2016.365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Currently undecided if plan to make IPD available will update the Clinical Trials Registry.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No