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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03141762
Enrollment
100
Registered
2017-05-05
Start date
2017-05-03
Completion date
2020-09-20
Last updated
2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Falls, Intensive care

Brief summary

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

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.

Interventions

None listed

Sponsors

Melbourne Health
CollaboratorOTHER
University of Kentucky
CollaboratorOTHER
University of Melbourne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Falls calendar - number of falls per month for 12 months, self-recorded by participantOne per month for 12 months12-monthly falls calendar - This will record time to first fall, falls, incidence, number of falls including injurious falls.

Secondary

MeasureTime frameDescription
Hand held dynamometryBaseline, 3, 6, and 12 months post dischargeMuscle strength
mini-BESTBaseline, 3, 6, and 12 months post dischargeBalance
4 metre walk testBaseline, 3, 6, and 12 months post dischargeGait
MoCABaseline, 3, 6, and 12 months post dischargeCognitive
Physical activity levelsBaseline, 3, 6, and 12 months post dischargePhysical activity as measured as per title. Assessed using a physical activity tracker that participants will wear.
Clinical frailty scale questionairreBaseline, 3, 6, and 12 months post dischargeFrailty
Falls Risk for Older People in the Community Setting (FROP-com) Questionairre3, 6, and 12 months post dischargeFalls risk
Fall efficacy scale questionnaire (version: FES-International short form)Baseline, 3, 6, and 12 months post dischargeIndividuals are asked to rate, on a four-point Likert scale, their concerns about the possibility of falling when performing 16 activities.
Hospital Anxiety and Depression Scale (HADS) QuestionairreBaseline, 3, 6, and 12 months post dischargeIt is a self-rating scale that measures anxiety and depression in both hospital and community settings.
EuroQol five dimensions questionnaire (version: EQ-5D-5L)Baseline, 3, 6, and 12 months post dischargeSelf-reported health-related quality of life questionnaire.
Muscle ultrasound imagingBaseline, 3, 6, and 12 months post dischargeUltrasound of rectus femoris and tibialis anterior
Short Physical Performance BatteryBaseline, 3, 6, and 12 months post dischargephysical test evaluation of balance, strength, and walking ability
Healthcare usage3, 6, and 12 months post dischargeCategorise readmissions and what health services are used post hospital discharge
FACIT Fatigue Scale (in subgroup)3, 6 and 12 monthsFatigue levels self report questionnaire
Sedentary behaviour questionnaire (in subgroup)3, 6, and 12 monthsWeekend and weekday questionnaire of sedentary behaviour in hours
Conor Davidson Resilience Questionnaire (in subgroup)3, 6, and 12 monthsself report resilience questionnaire
Life Orientation Revised Optimism Scale (in subgroup)3, 6, and 12 months10 item self report optimism scale, higher scores indicate higher optimism
Pittsburgh Sleep Quality Index (in subgroup)3, 6, and 12 monthsquestionnaire that evaluates sleep quality, higher scores indicate poorer sleep
MYMOP2 (in subgroup)3, 6, and 12 monthsshort questionnaire which asks patients to rate their top problems and activity limitations
Memorial symptoms questionnaire short form3, 6, and 12 monthsquestionnaire which covers different symptoms and how much it bothers the patient on a likert scale
Return to work3, 6 and 12 monthsquestionnaire which provides time to return to work and impact on finances
Impact of Event Scale questionnaire (version: IES-R)Baseline, 3, 6, and 12 months post dischargeIt is a self-reported questionnaire that measures It measures the severity of intrusion, avoidance, and hypervigilance symptoms, experienced over the past week.

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026