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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141762
• Other study ID #: 2016.365
• Status: Completed
• Start date: May 3, 2017
• Est. completion date: September 20, 2020

Study information

• Verified date: December 2023
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Australia	Melbourne Health	Melbourne	Victoria
United States	UK Healthcare	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Melbourne	Melbourne Health, University of Kentucky

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle ultrasound imaging	Ultrasound of rectus femoris and tibialis anterior	Baseline, 3, 6, and 12 months post discharge
Secondary	Hand held dynamometry	Muscle strength	Baseline, 3, 6, and 12 months post discharge
Secondary	mini-BEST	Balance	Baseline, 3, 6, and 12 months post discharge
Secondary	4 metre walk test	Gait	Baseline, 3, 6, and 12 months post discharge
Secondary	MoCA	Cognitive	Baseline, 3, 6, and 12 months post discharge
Secondary	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
Secondary	Clinical frailty scale questionairre	Frailty	Baseline, 3, 6, and 12 months post discharge
Secondary	Falls Risk for Older People in the Community Setting (FROP-com) Questionairre	Falls risk	3, 6, and 12 months post discharge
Secondary	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
Secondary	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
Secondary	EuroQol five dimensions questionnaire (version: EQ-5D-5L)	Self-reported health-related quality of life questionnaire.	Baseline, 3, 6, and 12 months post discharge
Secondary	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
Secondary	Short Physical Performance Battery	physical test evaluation of balance, strength, and walking ability	Baseline, 3, 6, and 12 months post discharge
Secondary	Healthcare usage	Categorise readmissions and what health services are used post hospital discharge	3, 6, and 12 months post discharge
Secondary	FACIT Fatigue Scale (in subgroup)	Fatigue levels self report questionnaire	3, 6 and 12 months
Secondary	Sedentary behaviour questionnaire (in subgroup)	Weekend and weekday questionnaire of sedentary behaviour in hours	3, 6, and 12 months
Secondary	Conor Davidson Resilience Questionnaire (in subgroup)	self report resilience questionnaire	3, 6, and 12 months
Secondary	Life Orientation Revised Optimism Scale (in subgroup)	10 item self report optimism scale, higher scores indicate higher optimism	3, 6, and 12 months
Secondary	Pittsburgh Sleep Quality Index (in subgroup)	questionnaire that evaluates sleep quality, higher scores indicate poorer sleep	3, 6, and 12 months
Secondary	MYMOP2 (in subgroup)	short questionnaire which asks patients to rate their top problems and activity limitations	3, 6, and 12 months
Secondary	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
Secondary	Return to work	questionnaire which provides time to return to work and impact on finances	3, 6 and 12 months