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Trial registered on ANZCTR


Registration number
ACTRN12619001330134p
Ethics application status
Submitted, not yet approved
Date submitted
29/08/2019
Date registered
30/09/2019
Date last updated
16/10/2019
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
Scientific title
Can hip protector devices prevent in-hospital fall-related injuries in frail older persons? The Hip-Frail Study
Secondary ID [1] 299141 0
None
Universal Trial Number (UTN)
U1111-1239-4485
Trial acronym
HIP-FRAIL
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Falls and Fall-related injuries in in-hospital older adults 314207 0
Condition category
Condition code
Injuries and Accidents 312566 312566 0 0
Other injuries and accidents
Injuries and Accidents 312567 312567 0 0
Fractures
Public Health 312683 312683 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315414 0
Prevention
Intervention code [2] 315415 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 321215 0
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.
Timepoint [1] 321215 0
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.
Secondary outcome [1] 374343 0
Secondary outcomes will be number of falls assessed by the fall and fall-related injuries diary
Timepoint [1] 374343 0
Number of falls will be assessed from hospital admission until hospital discharge.

Secondary outcome [2] 374688 0
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
Timepoint [2] 374688 0
Fall-related injuries will be assessed through the entire participant inpatient time.
Secondary outcome [3] 374689 0
Fear of falling will be assessed through. the Falls Efficacy Scale (FES-I), completed by the study team
Timepoint [3] 374689 0
Fear of falling will be assessed upon randomisation and prior to participant discharge, only two times during the study.

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.
Minimum age
75 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Orthogeriatrics patients (those admitted for treatment of fractures) due to the use of antiresorptive treatment.
• Bed bound
• Palliative care

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14661 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 14662 0
Footscray Hospital - Footscray
Recruitment hospital [3] 14663 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 27690 0
3021 - St Albans
Recruitment postcode(s) [2] 27691 0
3011 - Footscray
Recruitment postcode(s) [3] 27692 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 303681 0
Charities/Societies/Foundations
Name [1] 303681 0
HCF Research Foundation
Address [1] 303681 0
403 George Street,
Sydney NSW 2000
Country [1] 303681 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
176 Furlong Road,
St Albans, VIC, 3021
Country
Australia
Secondary sponsor category [1] 303786 0
University
Name [1] 303786 0
The University of Melbourne
Address [1] 303786 0
176 Furlong Rd,
St Albans, VIC 3021
Country [1] 303786 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304206 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 304206 0
Level 2
South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 304206 0
Australia
Date submitted for ethics approval [1] 304206 0
28/08/2019
Approval date [1] 304206 0
Ethics approval number [1] 304206 0

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.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60750 0
Prof Gustavo Duque
Address 60750 0
The University of Melbourne
176 Furlong Road, St Albans, VIC, 3021, Australia
Country 60750 0
Australia
Phone 60750 0
+61 3 83958212
Fax 60750 0
Email 60750 0
gustavo.duque@unimelb.edu.au
Contact person for public queries
Name 60751 0
Mrs Solange Bernardo
Address 60751 0
Western Health
176 Furlong Road, St Albans, VIC, 3021, Australia
Country 60751 0
Australia
Phone 60751 0
+61 383958231
Fax 60751 0
Email 60751 0
solange.bernardo@wh.org.au
Contact person for scientific queries
Name 60752 0
Prof Gustavo Duque
Address 60752 0
The University of Melbourne
176 Furlong Road, St Albans, VIC, 3021, Australia
Country 60752 0
Australia
Phone 60752 0
+61 3 83958212
Fax 60752 0
Email 60752 0
gustavo.duque@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 4426 0
Study protocol
Citation [1] 4426 0
Link [1] 4426 0
Email [1] 4426 0
diana.navarroperez@unimelb.edu.au
Other [1] 4426 0
Attachment [1] 4426 0
Type [2] 4427 0
Informed consent form
Citation [2] 4427 0
Link [2] 4427 0
Email [2] 4427 0
diana.navarroperez@unimelb.edu.au
Other [2] 4427 0
Attachment [2] 4427 0
Summary results
No Results