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

NCT ID: NCT03141762

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2020-09-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Critical Illness

Keywords

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Falls Intensive care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melbourne Health

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Selina M Parry

Chief Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selina Parry, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

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UK Healthcare

Lexington, Kentucky, United States

Site Status

Melbourne Health

Melbourne, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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2016.365

Identifier Type: -

Identifier Source: org_study_id