Critical IllnessNCT03141762
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
An observational study of Critical Illness, run by University of Melbourne at 2 sites in 2 countries.
Trial summary
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 May 2017to 20 Sep 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- hospitalised adults aged 18 years
- with an ICU admission requiring invasive mechanical ventilation for at least 48 hours and remain in ICU > 4 days
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
Read the 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.
- Conditions
- Critical Illness
- Keywords
- Falls, Intensive care
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One per month for 12 months
Secondary outcomes (22)
Muscle ultrasound imaging
Ultrasound of rectus femoris and tibialis anterior
Measured: Baseline, 3, 6, and 12 months post discharge
Hand held dynamometry
Muscle strength
Measured: Baseline, 3, 6, and 12 months post discharge
mini-BEST
Balance
Measured: Baseline, 3, 6, and 12 months post discharge
4 metre walk test
Gait
Measured: Baseline, 3, 6, and 12 months post discharge
MoCA
Cognitive
Measured: Baseline, 3, 6, and 12 months post discharge
Physical activity levels
Physical activity as measured as per title. Assessed using a physical activity tracker that participants will wear.
Measured: Baseline, 3, 6, and 12 months post discharge
Clinical frailty scale questionairre
Frailty
Measured: Baseline, 3, 6, and 12 months post discharge
Falls Risk for Older People in the Community Setting (FROP-com) Questionairre
Falls risk
Measured: 3, 6, and 12 months post discharge
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.
Measured: Baseline, 3, 6, and 12 months post discharge
Hospital Anxiety and Depression Scale (HADS) Questionairre
It is a self-rating scale that measures anxiety and depression in both hospital and community settings.
Measured: Baseline, 3, 6, and 12 months post discharge
EuroQol five dimensions questionnaire (version: EQ-5D-5L)
Self-reported health-related quality of life questionnaire.
Measured: Baseline, 3, 6, and 12 months post discharge
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.
Measured: Baseline, 3, 6, and 12 months post discharge
Short Physical Performance Battery
physical test evaluation of balance, strength, and walking ability
Measured: Baseline, 3, 6, and 12 months post discharge
Healthcare usage
Categorise readmissions and what health services are used post hospital discharge
Measured: 3, 6, and 12 months post discharge
FACIT Fatigue Scale (in subgroup)
Fatigue levels self report questionnaire
Measured: 3, 6 and 12 months
Sedentary behaviour questionnaire (in subgroup)
Weekend and weekday questionnaire of sedentary behaviour in hours
Measured: 3, 6, and 12 months
Conor Davidson Resilience Questionnaire (in subgroup)
self report resilience questionnaire
Measured: 3, 6, and 12 months
Life Orientation Revised Optimism Scale (in subgroup)
10 item self report optimism scale, higher scores indicate higher optimism
Measured: 3, 6, and 12 months
Pittsburgh Sleep Quality Index (in subgroup)
questionnaire that evaluates sleep quality, higher scores indicate poorer sleep
Measured: 3, 6, and 12 months
MYMOP2 (in subgroup)
short questionnaire which asks patients to rate their top problems and activity limitations
Measured: 3, 6, and 12 months
Memorial symptoms questionnaire short form
questionnaire which covers different symptoms and how much it bothers the patient on a likert scale
Measured: 3, 6, and 12 months
Return to work
questionnaire which provides time to return to work and impact on finances
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start3 May 2017
- Primary completion20 Sep 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health, University of Kentucky
- Responsible party
- Principal investigator, Selina M Parry, University of Melbourne
- Investigators
- Selina Parry, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141762
- Sponsor's protocol ID
- 2016.365
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2017
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently undecided if plan to make IPD available will update the Clinical Trials Registry.
Publications
Parry SM, Soh SE, Morris PE, Larkin JS, Hosey MM, Da Silva AA, Alexander EK, Wells M, Elsegood NK, Kinnersly EG, Beach LJ, Mayer KP, Oliveira CC, McGinley JL, Puthucheary Z, Denehy L, Granger CL. "From the moment I started standing again, I was worried about falls": fear of falling in intensive care unit survivors over 12 months. Ann Am Thorac Soc. 2026 Mar 1;23(3):397-408. doi: 10.1513/AnnalsATS.202503-314OC.
PubMed 41052427
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
- ClinicalTrials.gov ID
- NCT03141762
- Acronym / sponsor ID
- 2016.365
- Conditions
- Critical Illness
- Keywords
- Falls, Intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Melbourne Health, University of Kentucky
- Study start
- 3 May 2017 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- hospitalised adults aged 18 years
- with an ICU admission requiring invasive mechanical ventilation for at least 48 hours and remain in ICU > 4 days
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
22 secondary outcomes
Muscle ultrasound imaging
Time frame: Baseline, 3, 6, and 12 months post discharge
Hand held dynamometry
Time frame: Baseline, 3, 6, and 12 months post discharge
mini-BEST
Time frame: Baseline, 3, 6, and 12 months post discharge
4 metre walk test
Time frame: Baseline, 3, 6, and 12 months post discharge
MoCA
Time frame: Baseline, 3, 6, and 12 months post discharge
Physical activity levels
Time frame: Baseline, 3, 6, and 12 months post discharge
Clinical frailty scale questionairre
Time frame: 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
Fall efficacy scale questionnaire (version: FES-International short form)
Time frame: 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
EuroQol five dimensions questionnaire (version: EQ-5D-5L)
Time frame: 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
Short Physical Performance Battery
Time frame: Baseline, 3, 6, and 12 months post discharge
Healthcare usage
Time frame: 3, 6, and 12 months post discharge
FACIT Fatigue Scale (in subgroup)
Time frame: 3, 6 and 12 months
Sedentary behaviour questionnaire (in subgroup)
Time frame: 3, 6, and 12 months
Conor Davidson Resilience Questionnaire (in subgroup)
Time frame: 3, 6, and 12 months
Life Orientation Revised Optimism Scale (in subgroup)
Time frame: 3, 6, and 12 months
Pittsburgh Sleep Quality Index (in subgroup)
Time frame: 3, 6, and 12 months
MYMOP2 (in subgroup)
Time frame: 3, 6, and 12 months
Memorial symptoms questionnaire short form
Time frame: 3, 6, and 12 months
Return to work
Time frame: 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 41052427Parry SM, Soh SE, Morris PE, Larkin JS, Hosey MM, Da Silva AA, Alexander EK, Wells M, Elsegood NK, Kinnersly EG, Beach LJ, Mayer KP, Oliveira CC, McGinley JL, Puthucheary Z, Denehy L, Granger CL. "From the moment I started standing again, I was worried about falls": fear of falling in intensive care unit survivors over 12 months. Ann Am Thorac Soc. 2026 Mar 1;23(3):397-408. doi: 10.1513/AnnalsATS.202503-314OC.
- Individual participant dataSharing planned: Undecided. Currently undecided if plan to make IPD available will update the Clinical Trials Registry.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina Parry, PhD principal investigator
University of Melbourne
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University of Melbourne at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls calendar - number of falls per month for 12 months, self-recorded by participant (time frame: One per month for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.