Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000672651
Ethics application status
Approved
Date submitted
19/10/2005
Date registered
21/10/2005
Date last updated
5/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial to reduce further falls and injuries for older fallers presenting to an Emergency Department.
Scientific title
A randomised controlled trial to evaluate the effectiveness of a targeted and personalised multifactorial program to reduce further falls and injuries for community-dwelling older fallers presenting to and being discharged directly from an Emergency Department.
Universal Trial Number (UTN)
Trial acronym
Falls and ED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls. 820 0
Condition category
Condition code
Injuries and Accidents 884 884 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of this project is to evaluate the effectiveness of a targeted multi-factor intervention in improving health and well being of older people who present to an Emergency Department (ED) following a fall. It also aims to identify those within this high-risk population most likely to benefit from the intervention program. Those who are eligible to participate receive a falls risk assessment in their own home and are required to complete a falls diary for 12 months. Participants are randomised into either an individualised falls prevention program or ⿿usual care⿝. Intervention is based on individual falls risk assessment and includes referral/s to other health services such as GPs, Falls Clinics, Physiotherapists, Occupational Therapists, Podiatrists and Dietitians. All participants will be followed up to 12 months and receive 12-month follow-up falls risk assessments in their own homes.
Intervention code [1] 729 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1146 0
To evaluate the effectiveness of a customised multifactorial intervention in reducing falls, compared to "usual care".
Timepoint [1] 1146 0
Primary outcome [2] 1147 0
To evaluate the effectiveness of a customised multifactorial intervention in reducing falls related injury rates, compared to "usual care".
Timepoint [2] 1147 0
Secondary outcome [1] 2107 0
To accurately identify the circumstances, contributory factors and consequences of falls for older people presenting to Emergency Departments following a fall.
Timepoint [1] 2107 0
Secondary outcome [2] 2108 0
To evaluate the effectiveness of the intervention program in improving secondary health and well-being measures, including physical, psychological (fear of falling, depression), and quality of life indices.
Timepoint [2] 2108 0
Secondary outcome [3] 2109 0
To identify the physical, functional, and cognitive (executive function) parameters most strongly associated with good outcome.
Timepoint [3] 2109 0
Secondary outcome [4] 2110 0
To conduct an economic evaluation of the interventions and outcomes.
Timepoint [4] 2110 0
Secondary outcome [5] 2111 0
To provide guidelines for future management of high risk older people presenting to Emergency departments.
Timepoint [5] 2111 0

Eligibility
Key inclusion criteria
Presenting to the Emergency Department with the primary cause of presentation being a fall; discharged directly home following emergency care; living in the community or a retirement village; willing to take part in the study; able to provide informed consent or has consent provided by a third party; able to comply with simple instructions; able to walk independently indoors with or without a gait aid.
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
A research assistant unrelated to this RCT holds the random allocation (remote randomisation). The random allocation will be made available to the investigators and participants only following the completion of the baseline falls risk assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated stratified random numbers is being used for this RCT.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 974 0
Government body
Name [1] 974 0
Department of Veterans' Affairs
Country [1] 974 0
Australia
Funding source category [2] 975 0
Government body
Name [2] 975 0
Victorian Department of Human Services
Country [2] 975 0
Australia
Primary sponsor type
Government body
Name
Department of Veterans' Affairs and Victorian Department of Human Services
Address
Country
Australia
Secondary sponsor category [1] 842 0
None
Name [1] 842 0
nil
Address [1] 842 0
Country [1] 842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2278 0
Melbourne Health-Royal Melbourne Hospital
Ethics committee address [1] 2278 0
Ethics committee country [1] 2278 0
Australia
Date submitted for ethics approval [1] 2278 0
Approval date [1] 2278 0
Ethics approval number [1] 2278 0
Ethics committee name [2] 2279 0
Melbourne Health-Western Hospital
Ethics committee address [2] 2279 0
Ethics committee country [2] 2279 0
Australia
Date submitted for ethics approval [2] 2279 0
Approval date [2] 2279 0
Ethics approval number [2] 2279 0
Ethics committee name [3] 2280 0
Melbourne Health-Sunshine Hospital
Ethics committee address [3] 2280 0
Ethics committee country [3] 2280 0
Australia
Date submitted for ethics approval [3] 2280 0
Approval date [3] 2280 0
Ethics approval number [3] 2280 0
Ethics committee name [4] 2281 0
Melbourne Health-Williamstown Hospital
Ethics committee address [4] 2281 0
Ethics committee country [4] 2281 0
Australia
Date submitted for ethics approval [4] 2281 0
Approval date [4] 2281 0
Ethics approval number [4] 2281 0
Ethics committee name [5] 2282 0
Bayside Health-Sandringham Hospital
Ethics committee address [5] 2282 0
Ethics committee country [5] 2282 0
Australia
Date submitted for ethics approval [5] 2282 0
Approval date [5] 2282 0
Ethics approval number [5] 2282 0
Ethics committee name [6] 2283 0
The Alfred
Ethics committee address [6] 2283 0
Ethics committee country [6] 2283 0
Australia
Date submitted for ethics approval [6] 2283 0
Approval date [6] 2283 0
Ethics approval number [6] 2283 0
Ethics committee name [7] 2284 0
Austin Health-Austin Hospital
Ethics committee address [7] 2284 0
Ethics committee country [7] 2284 0
Australia
Date submitted for ethics approval [7] 2284 0
Approval date [7] 2284 0
Ethics approval number [7] 2284 0
Ethics committee name [8] 2285 0
Northern Health-Northern Hospital
Ethics committee address [8] 2285 0
Ethics committee country [8] 2285 0
Australia
Date submitted for ethics approval [8] 2285 0
Approval date [8] 2285 0
Ethics approval number [8] 2285 0
Ethics committee name [9] 2286 0
University of Melbourne
Ethics committee address [9] 2286 0
Ethics committee country [9] 2286 0
Australia
Date submitted for ethics approval [9] 2286 0
Approval date [9] 2286 0
Ethics approval number [9] 2286 0

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

Contacts
Principal investigator
Name 35316 0
Address 35316 0
Country 35316 0
Phone 35316 0
Fax 35316 0
Email 35316 0
Contact person for public queries
Name 9918 0
Dr Irene Blackberry
Address 9918 0
National Ageing Research Institute
University of Melbourne
PO Box 31
Parkville VIC 3052
Country 9918 0
Australia
Phone 9918 0
+61 3 83872163
Fax 9918 0
+61 3 83872153
Email 9918 0
[email protected]
Contact person for scientific queries
Name 846 0
Associate Professor Keith Hill
Address 846 0
National Ageing Research Institute
University of Melbourne
PO Box 31
Parkville VIC 3052
Country 846 0
Australia
Phone 846 0
+61 3 83872163
Fax 846 0
+61 3 83872153
Email 846 0
[email protected]

No information has been provided regarding IPD availability


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.