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Trial registered on ANZCTR
Registration number
ACTRN12619001330134
Ethics application status
Approved
Date submitted
29/08/2019
Date registered
30/09/2019
Date last updated
22/07/2022
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Prevention of in-hospital fall-related injuries in frail older persons. The Hip-Frail Study
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Scientific title
Can hip protector devices prevent in-hospital fall-related injuries in frail older persons? The Hip-Frail Study
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Secondary ID [1]
299141
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None
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Universal Trial Number (UTN)
U1111-1239-4485
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Trial acronym
HIP-FRAIL
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Falls and Fall-related injuries in in-hospital older adults
314207
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Condition category
Condition code
Injuries and Accidents
312566
312566
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0
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Other injuries and accidents
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Injuries and Accidents
312567
312567
0
0
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Fractures
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Public Health
312683
312683
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention group will receive a standard of care for fall prevention in addition to wearing a Hip protector device. Hip Protectors are comparable to padded undergarments that shield the trochanter, reducing the effects and force impacting the bone during a fall.
The study team will administer 4 hip protectors (taking into consideration the hospital length of stay, two hip protectors are given per week of stay) to patients allocated to this group upon randomization. Hip protectors are fabricated by a pair of shields fitted to the underpants, shields are located at each side protector the hip. Patients will wear the hip protector device, only during the day while they remain inpatient at the hospital.
Adherence to hip protectors will be evaluated through the hip protectors use diary which will be completed three times per day by the nursing staff.
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Intervention code [1]
315414
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Prevention
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Intervention code [2]
315415
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Treatment: Devices
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Comparator / control treatment
Control group: Participants allocated to the control group will receive only the standard of care for fall prevention, consisting in minimizing the potential hazards such as placing the patient on a chair, a bed alarm, ward orientation, proper foot ware, proper signage and specific toilet rounds.
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Control group
Active
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Outcomes
Primary outcome [1]
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Primary outcome will be adherence to the use of hip protectors during the participant’s hospital stay. This outcome will be assessed through the hip protectors diary which will be completed three times per day by the nursing staff.
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Assessment method [1]
321215
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Timepoint [1]
321215
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Hip protectors diary will be completed every day (3 times per day) 48 hr after participant has been admitted to a geriatric acute ward until 24 hr prior participant discharge.
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Secondary outcome [1]
374343
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Secondary outcomes will be number of falls assessed by the fall and fall-related injuries diary
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Assessment method [1]
374343
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Timepoint [1]
374343
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Number of falls will be assessed from hospital admission until hospital discharge.
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Secondary outcome [2]
374688
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Fall-related injuries (hip fractures, local residual pain, and local haematoma) will be assessed through the fall and fall-related injury diary completed by the nursing staff and study team
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Assessment method [2]
374688
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Timepoint [2]
374688
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Fall-related injuries will be assessed through the entire participant inpatient time.
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Secondary outcome [3]
374689
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Fear of falling will be assessed through. the Falls Efficacy Scale (FES-I), completed by the study team
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Assessment method [3]
374689
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Timepoint [3]
374689
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Fear of falling will be assessed upon randomisation and prior to participant discharge, only two times during the study.
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Eligibility
Key inclusion criteria
• Males and females aged 75 years or older
• Males and females who are non-native English speakers are eligible for consideration when an impartial witness is available at the time of consenting and assessments.
• Males and females with a mini mental score for cognitive impairment above 18.
• Admitted to an acute ward for general medical conditions and expected to stay at the Western Health system (acute and subacute) for at least 2 weeks
• Frailty diagnosed using the clinical frailty scale (CFS). Frailty will be diagnosed as per CFS in conjunction with the medical records as part of the routinely admission procedures.
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Minimum age
75
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Orthogeriatrics patients (those admitted for treatment of fractures) due to the use of antiresorptive treatment.
• Bed bound
• Palliative care
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients eligible and meeting inclusion criteria will be randomised to one of two groups:
Group 1: Intervention – hip protectors plus usual care
Group 2: Control – usual care
Randomisation: Permuted block design randomization will be used, stratified by the hospital site (3 sites). The randomization will be performed at visit 1 via RedCap database management system. The allocation sequence will be concealed until the time of the randomization.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A Simple randomisation will be carried out using a computer software RedCap, stratified by hospital.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
All results will be reported according to CONSORT guidelines.
Detailed descriptive statistics will be presented for the primary outcome – adherence to hip protectors. Median and interquartile range of the proportion of the time patients’ wore hip protectors as well as the number and proportion of patients wearing a hip protector for at least 70% of their hospital admissions will be presented. Reasons for non-adherence will be listed. Linear regression will be used to explore whether other patient’s characteristics (age, gender, reason for admission, etc.) are associated with the adherence to hip protectors (defined as the proportion of time during hospital admission that hip protectors were worn).
Efficacy of the hip protectors in reducing falls and falls-related injuries during the hospital stay will be analysed using negative binomial regression (or zero inflated negative binomial regression in case of large number of participants without any falls) adjusting for the duration of hospital stay. Results will be presented as incidence rate ratio with 95% confidence intervals. The effect on fear of falling will be estimated using ANCOVA with adjustment for baseline values. If required, outcome will be transformed using natural logarithm.
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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Date of first participant enrolment
Anticipated
15/10/2020
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Actual
5/03/2021
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Date of last participant enrolment
Anticipated
31/12/2022
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Actual
11/06/2021
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Date of last data collection
Anticipated
31/01/2023
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Actual
15/06/2022
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Sample size
Target
120
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Accrual to date
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Final
2
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
14661
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Sunshine Hospital - St Albans
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Recruitment hospital [2]
14662
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Footscray Hospital - Footscray
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Recruitment hospital [3]
14663
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Williamstown Hospital - Williamstown
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Recruitment postcode(s) [1]
27691
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3011 - Footscray
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Recruitment postcode(s) [2]
27692
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3016 - Williamstown
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Recruitment postcode(s) [3]
27690
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3021 - St Albans
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Funding & Sponsors
Funding source category [1]
303681
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Charities/Societies/Foundations
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Name [1]
303681
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HCF Research Foundation
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Address [1]
303681
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403 George Street,
Sydney NSW 2000
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Country [1]
303681
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Australia
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Primary sponsor type
Hospital
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Name
Western Health
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Address
176 Furlong Road,
St Albans, VIC, 3021
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Country
Australia
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Secondary sponsor category [1]
303786
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University
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Name [1]
303786
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The University of Melbourne
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Address [1]
303786
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176 Furlong Rd,
St Albans, VIC 3021
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Country [1]
303786
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304206
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
304206
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Level 2 South West 300 Grattan Street Parkville VIC 3050
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Ethics committee country [1]
304206
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Australia
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Date submitted for ethics approval [1]
304206
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28/08/2019
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Approval date [1]
304206
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17/10/2019
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Ethics approval number [1]
304206
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Summary
Brief summary
Frail older persons are at high risk of hospitalization due to acute events associated with chronic diseases. The combination of frailty, functional deterioration, and acute conditions substantially increase the risk of falling, and hence the likelihood of incurring a fall-related injury. Those injuries (i.e. fractures, soft tissue trauma, residual pain, etc.) not only have devastating consequences on an individual's quality of life but may also affect a hospital's reputation in the community. In addition, hospitals may face litigation claims and increased costs for patients who fall and suffer a major injury as a consequence. External hip protectors are comparable to padded undergarments and shield the trochanter, reducing the detrimental effects and force impacting the bone during a fall. Screening for patients at high risk of falling and providing high-risk patients with hip protectors as a preventive measure to avoid hip fractures and other fall-related injuries, not only improves public health, but can also save hospitals care and litigation costs. It has also been demonstrated to be a cost-effective intervention. However, the acceptance of hip protectors by frail older persons and those factors affecting in-hospital adherence remain unknown. This study will aim to assess the tolerability and acceptability of hip protectors and the prevention of fall-related injuries in hospitalised frail older persons.
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Trial website
NA
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Gustavo Duque
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Address
60750
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The University of Melbourne
176 Furlong Road, St Albans, VIC, 3021, Australia
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Country
60750
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Australia
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Phone
60750
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+61 3 83958212
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Fax
60750
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Email
60750
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gustavo.duque@unimelb.edu.au
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Contact person for public queries
Name
60751
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Solange Bernardo
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Address
60751
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Western Health
176 Furlong Road, St Albans, VIC, 3021, Australia
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Country
60751
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Australia
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Phone
60751
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+61 383958231
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Fax
60751
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Email
60751
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solange.bernardo@wh.org.au
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Contact person for scientific queries
Name
60752
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Gustavo Duque
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Address
60752
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The University of Melbourne
176 Furlong Road, St Albans, VIC, 3021, Australia
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Country
60752
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Australia
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Phone
60752
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+61 3 83958212
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Fax
60752
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Email
60752
0
gustavo.duque@unimelb.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No individual participant data will be available. Overall data presented in publications, seminars or presentations will be in a de-identified manner.
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
diana.navarroperez@unimelb.edu.au
Informed consent form
diana.navarroperez@unimelb.edu.au
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF