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

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ClinicalTrials.gov Identifier: NCT03141762
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
Austin Health
Melbourne Health
University of Kentucky
Information provided by (Responsible Party):
Selina M Parry, University of Melbourne

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

Condition or disease
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. It is a multicentre study over three sites: UK Healthcare, Melbourne Health and Austin Health. All adult patients in intensive care that have been mechanically ventilated for over 24 hours, and remain in the ICU more than 4 days will be considerer 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 [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls




Primary Outcome Measures :
  1. Falls calendar - number of falls per month for 12 months, self-recorded by participant [ Time Frame: One per month for 12 months ]
    12-monthly falls calendar - This will record time to first fall, falls, incidence, number of falls including injurious falls.


Secondary Outcome Measures :
  1. Muscle ultrasound imaging [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Ultrasound of rectus femoris and tibialis anterior

  2. Hand held dynamometry [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Muscle strength

  3. mini-BEST [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Balance

  4. 4 metre walk test [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Gait

  5. MoCA [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Cognitive

  6. Physical activity levels - measured via metabolic equivalent of task (MET) and steps per day [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Physical activity as measured as per title. Assessed using a physical activity tracker that participants will wear.

  7. Clinical frailty scale questionairre [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Frailty

  8. Falls Risk for Older People in the Community Setting (FROP-com) Questionairre [ Time Frame: 3, 6, and 12 months post discharge ]
    Falls risk

  9. Fall efficacy scale questionnaire (version: FES-International short form) [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Individuals are asked to rate, on a four-point Likert scale, their concerns about the possibility of falling when performing 16 activities.

  10. Hospital Anxiety and Depression Scale (HADS) Questionairre [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    It is a self-rating scale that measures anxiety and depression in both hospital and community settings.

  11. EuroQol five dimensions questionnaire (version: EQ-5D-5L) [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    Self-reported health-related quality of life questionnaire.

  12. Impact of Event Scale questionnaire (version: IES-R) [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    It is a self-reported questionnaire that measures It measures the severity of intrusion, avoidance, and hypervigilance symptoms, experienced over the past week.

  13. Short Physical Performance Battery [ Time Frame: Baseline, 3, 6, and 12 months post discharge ]
    physical test evaluation of balance, strength, and walking ability



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141762


Contacts
Contact: Selina Parry, PhD 61383444171 selina.parry@unimelb.edu.au
Contact: Catherine Granger, PhD catherine.granger@mh.org.au

Locations
United States, Kentucky
UK Healthcare Recruiting
Lexington, Kentucky, United States, 40536
Contact: Peter E Morris, MD       peter.morris@uky.edu   
Sub-Investigator: Ashley Montgomery, MD         
Australia, Victoria
Austin Health Recruiting
Melbourne, Victoria, Australia
Contact: Selina Parry, PhD       selina.parry@unimelb.edu.au   
Melbourne Health Recruiting
Melbourne, Victoria, Australia
Contact: Catherine Granger, PhD       Catherine.Granger@mh.org.au   
Sponsors and Collaborators
University of Melbourne
Austin Health
Melbourne Health
University of Kentucky

Responsible Party: Selina M Parry, Chief Investigator, University of Melbourne
ClinicalTrials.gov Identifier: NCT03141762     History of Changes
Other Study ID Numbers: 2016.365
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently undecided if plan to make IPD available will update the Clinical Trials Registry.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Selina M Parry, University of Melbourne:
Falls
Intensive care

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes