Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000201774
Ethics application status
Approved
Date submitted
1/12/2021
Date registered
7/02/2022
Date last updated
7/02/2022
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing a fracture risk application (app) to support care planning in aged care residents in Australia.
Scientific title
Evaluating the implementation of a Fracture Risk Clinical Assessment Protocol and fracture risk app to support care planning for Residential Aged Care Facilities in Australia.
Secondary ID [1] 305650 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The RAC-Fx Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 324145 0
Condition category
Condition code
Musculoskeletal 321619 321619 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will evaluate a web-tool called 'Break Free' that has been developed to increase the identification of osteoporosis risk and to recommend treatment(s) based on risk level, for residents of Australian Residential Aged Care Facilities (RACFs). Embedded in the web-tool are a set of fracture risk Clinical Assessment Protocols (CAPs) which are based on the latest Australian guidelines and position statements from industry bodies including Healthy Bones Australia (formerly Osteoporosis Australia) and the Royal Australian College of General Practitioners (RACGP) for fracture prevention in RACF.
Staff at participating RACFs will be provided with access to the tool for a period of 12 months. The tool is intended to be used by RACF staff and will involve completion of a short questionnaire which captures information about the residents age, gender, BMI and a series of questions related to history of falls and fractures, activities of daily living, cognition and current fracture prevention medication and non-pharmacological interventions. The assessment takes approx. 6 minutes to complete.
The ‘Break Free’ webtool has been developed by researchers at the Australian Institute for Musculoskeletal Science (AIMSS), adapted from the Canadian Fracture Risk Scale (FRS) developed and validated by our collaborators at the GERAS (Geriatric Education and Research in Aging Sciences) Centre for Aging Research.
Intervention code [1] 322067 0
Prevention
Comparator / control treatment
Historical, one year pre-implementation aggregated data obtained via publicly available sources i.e. Medicare will be used as a comparator in this study.
Control group
Historical

Outcomes
Primary outcome [1] 329381 0
Number of RACF residents identified at each risk level using data collected with the BreakFree web application compared to pre-implementation values.
Timepoint [1] 329381 0
12 months post protocol-implementation
Secondary outcome [1] 402397 0
To identify the number of osteoporosis treatments initiated for the duration of the study using the BreakFree web application compared to pre-implementation values.
Timepoint [1] 402397 0
12 months post protocol-implementation

Eligibility
Key inclusion criteria
Residential Aged Care Facilities (RACF) located within Victoria. Access to the web application will be provided to health care professionals employed within participating RACFS.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
At least 20 RACFs will be recruited (convenience sample). It is expected that there will be at least 120 high risk residents which will provide reliable estimation of proportions and will add generalizability of the results.
All outcomes will be reported as N, percentage and 95% confidence intervals. Binomial probability test will be used to compare the results to aggregate results of the year prior to the implementation.
All data will be analysed using SPSS Statistics Version 19 (IBM, USA), and/or Stata, version 16.1 (StataCorp LP, Texas).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310035 0
Commercial sector/Industry
Name [1] 310035 0
AMGEN
Country [1] 310035 0
Australia
Funding source category [2] 310287 0
Charities/Societies/Foundations
Name [2] 310287 0
Healthy Bones Australia (formerly Osteoporosis Australia)
Country [2] 310287 0
Australia
Funding source category [3] 310288 0
Charities/Societies/Foundations
Name [3] 310288 0
Australian and New Zealand Bone and Mineral Society (ANZBMS)
Country [3] 310288 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Level 5, 161 Barry Street, Carlton Vic 3010
Country
Australia
Secondary sponsor category [1] 311713 0
None
Name [1] 311713 0
Address [1] 311713 0
Country [1] 311713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309717 0
Melbourne Health HREC
Ethics committee address [1] 309717 0
Ethics committee country [1] 309717 0
Australia
Date submitted for ethics approval [1] 309717 0
23/06/2020
Approval date [1] 309717 0
28/08/2020
Ethics approval number [1] 309717 0
HREC/60269/MH-2020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115146 0
Prof Gustavo Duque
Address 115146 0
Department of Medicine, Western Health
Level 3 WCHRE Building
Sunshine Hospital
176 Furlong Road
St. Albans VIC 3021
Country 115146 0
Australia
Phone 115146 0
+61 38395 8121
Fax 115146 0
Email 115146 0
[email protected]
Contact person for public queries
Name 115147 0
Sonia La Vita
Address 115147 0
Department of Medicine, Western Health
Level 4 WCHRE Building
Sunshine Hospital
176 Furlong Road
St. Albans VIC 3021
Country 115147 0
Australia
Phone 115147 0
+61408923464
Fax 115147 0
Email 115147 0
[email protected]
Contact person for scientific queries
Name 115148 0
Gustavo Duque
Address 115148 0
Department of Medicine, Western Health
Level 3 WCHRE Building
Sunshine Hospital
176 Furlong Road
St. Albans VIC 3021
Country 115148 0
Australia
Phone 115148 0
+61 38395 8121
Fax 115148 0
Email 115148 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.