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

December 21, 2023 updated by: Selina M Parry, University of Melbourne
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • Melbourne Health
  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • UK HealthCare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One per month for 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle ultrasound imaging
Time Frame: Baseline, 3, 6, and 12 months post discharge
Ultrasound of rectus femoris and tibialis anterior
Baseline, 3, 6, and 12 months post discharge
Hand held dynamometry
Time Frame: Baseline, 3, 6, and 12 months post discharge
Muscle strength
Baseline, 3, 6, and 12 months post discharge
mini-BEST
Time Frame: Baseline, 3, 6, and 12 months post discharge
Balance
Baseline, 3, 6, and 12 months post discharge
4 metre walk test
Time Frame: Baseline, 3, 6, and 12 months post discharge
Gait
Baseline, 3, 6, and 12 months post discharge
MoCA
Time Frame: Baseline, 3, 6, and 12 months post discharge
Cognitive
Baseline, 3, 6, and 12 months post discharge
Physical activity levels
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.
Baseline, 3, 6, and 12 months post discharge
Clinical frailty scale questionairre
Time Frame: Baseline, 3, 6, and 12 months post discharge
Frailty
Baseline, 3, 6, and 12 months post discharge
Falls Risk for Older People in the Community Setting (FROP-com) Questionairre
Time Frame: 3, 6, and 12 months post discharge
Falls risk
3, 6, and 12 months post discharge
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.
Baseline, 3, 6, and 12 months post discharge
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.
Baseline, 3, 6, and 12 months post discharge
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.
Baseline, 3, 6, and 12 months post discharge
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.
Baseline, 3, 6, and 12 months post discharge
Short Physical Performance Battery
Time Frame: Baseline, 3, 6, and 12 months post discharge
physical test evaluation of balance, strength, and walking ability
Baseline, 3, 6, and 12 months post discharge
Healthcare usage
Time Frame: 3, 6, and 12 months post discharge
Categorise readmissions and what health services are used post hospital discharge
3, 6, and 12 months post discharge
FACIT Fatigue Scale (in subgroup)
Time Frame: 3, 6 and 12 months
Fatigue levels self report questionnaire
3, 6 and 12 months
Sedentary behaviour questionnaire (in subgroup)
Time Frame: 3, 6, and 12 months
Weekend and weekday questionnaire of sedentary behaviour in hours
3, 6, and 12 months
Conor Davidson Resilience Questionnaire (in subgroup)
Time Frame: 3, 6, and 12 months
self report resilience questionnaire
3, 6, and 12 months
Life Orientation Revised Optimism Scale (in subgroup)
Time Frame: 3, 6, and 12 months
10 item self report optimism scale, higher scores indicate higher optimism
3, 6, and 12 months
Pittsburgh Sleep Quality Index (in subgroup)
Time Frame: 3, 6, and 12 months
questionnaire that evaluates sleep quality, higher scores indicate poorer sleep
3, 6, and 12 months
MYMOP2 (in subgroup)
Time Frame: 3, 6, and 12 months
short questionnaire which asks patients to rate their top problems and activity limitations
3, 6, and 12 months
Memorial symptoms questionnaire short form
Time Frame: 3, 6, and 12 months
questionnaire which covers different symptoms and how much it bothers the patient on a likert scale
3, 6, and 12 months
Return to work
Time Frame: 3, 6 and 12 months
questionnaire which provides time to return to work and impact on finances
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Melbourne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Melbourne Health
University of Kentucky

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Selina Parry, PhD, University of Melbourne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016.365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Currently undecided if plan to make IPD available will update the Clinical Trials Registry.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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