Clinical trial NCT03141762: Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
Official title: Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Falls
Intensive care
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Melbourne Health
name: University of Kentucky
First posted: 2017-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Falls calendar - number of falls per month for 12 months, self-recorded by participant
timeFrame: One per month for 12 months
Secondary outcomes:
measure: Muscle ultrasound imaging
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: Hand held dynamometry
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: mini-BEST
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: 4 metre walk test
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: MoCA
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: Physical activity levels
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: Clinical frailty scale questionairre
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: Falls Risk for Older People in the Community Setting (FROP-com) Questionairre
timeFrame: 3, 6, and 12 months post discharge
measure: Fall efficacy scale questionnaire (version: FES-International short form)
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: Hospital Anxiety and Depression Scale (HADS) Questionairre
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: EuroQol five dimensions questionnaire (version: EQ-5D-5L)
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: Impact of Event Scale questionnaire (version: IES-R)
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: Short Physical Performance Battery
timeFrame: Baseline, 3, 6, and 12 months post discharge
measure: Healthcare usage
timeFrame: 3, 6, and 12 months post discharge
measure: FACIT Fatigue Scale (in subgroup)
timeFrame: 3, 6 and 12 months
measure: Sedentary behaviour questionnaire (in subgroup)
timeFrame: 3, 6, and 12 months
measure: Conor Davidson Resilience Questionnaire (in subgroup)
timeFrame: 3, 6, and 12 months
measure: Life Orientation Revised Optimism Scale (in subgroup)
timeFrame: 3, 6, and 12 months
measure: Pittsburgh Sleep Quality Index (in subgroup)
timeFrame: 3, 6, and 12 months
measure: MYMOP2 (in subgroup)
timeFrame: 3, 6, and 12 months
measure: Memorial symptoms questionnaire short form
timeFrame: 3, 6, and 12 months
measure: Return to work
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: UK Healthcare
state: Kentucky
city: Melbourne
country: Australia
facility: Melbourne Health
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Selina Parry, PhD
role: PRINCIPAL_INVESTIGATOR
References: