Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000398404
Ethics application status
Approved
Date submitted
31/07/2007
Date registered
2/08/2007
Date last updated
26/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Falls prevention for stroke patients following discharge home: A randomised trial intervention
Scientific title
Falls prevention for stroke patients following discharge home: A randomised trial evaluating a multifactorial falls prevention program
Secondary ID [1] 288006 0
nil known
Universal Trial Number (UTN)
Trial acronym
FLASSH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke, falls 2203 0
Condition category
Condition code
Stroke 2298 2298 0 0
Ischaemic
Stroke 3025 3025 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multifactorial individualised falls prevention program based on falls risk factors including a home exercise program, falls education, referral to address factors identified in falls risk assessment. Home exercise program will continue for 12 months, education session will be undertaken within two weeks of randomisation to the intervention group (one session only). The intervention will be additional to usual care, that is the therapy prescribed by the discharging facility.
Intervention code [1] 1918 0
Other interventions
Comparator / control treatment
Usual care which includes treatment as determined by the discharging facility. This may include outpatient therapy, exercise. Duration of usual care will vary according to the primary treating therapist, but generally will occur for approximately 3 months.
Control group
Active

Outcomes
Primary outcome [1] 3188 0
Falls - time to first fall, fall rate. Falls data will be collected prospectively via fall calendars which are filled out by the participants and returned to the researchers after the end of each month. Data will be analysed at the end of 12 months.
Timepoint [1] 3188 0
At one year after randomisation
Secondary outcome [1] 5317 0
Falls efficacy
Timepoint [1] 5317 0
Measured at baseline, 4, 8 & 12 months after randomisation
Secondary outcome [2] 5318 0
Gait velocity
Timepoint [2] 5318 0
Measured at baseline and 12 months after randomisation
Secondary outcome [3] 5319 0
Balance - step test
Timepoint [3] 5319 0
Measured at baseline and 12 months after randomisation
Secondary outcome [4] 5320 0
Functional status
Timepoint [4] 5320 0
Measured at baseline and 12 months after randomisation

Eligibility
Key inclusion criteria
Stroke patients discharged home from sub-acute, at risk of falls due to previous fall or balance impairment.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients discharged to residential care facilities, patients and carers without basic English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are enrolled if they meet inclusion criteria and provide consent. Following baseline assessment, subjects are randomised to receive control or intervention. Allocation occurs using sealed envelopes which contain group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
The outcome assessor is blind
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
11/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
214
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2461 0
Government body
Name [1] 2461 0
National Health and Medical Research Council
Country [1] 2461 0
Australia
Primary sponsor type
Individual
Name
Professor Keith Hill
Address
34-54 Poplar Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 2234 0
Individual
Name [1] 2234 0
Dr Catherine Said
Address [1] 2234 0
Austin Health
Country [1] 2234 0
Australia
Secondary sponsor category [2] 2235 0
Individual
Name [2] 2235 0
Dr Shylie Mackintosh
Address [2] 2235 0
University of South Australia
Country [2] 2235 0
Australia
Secondary sponsor category [3] 2236 0
Individual
Name [3] 2236 0
Dr Craig Whitehead
Address [3] 2236 0
Repatriation General Hospital, Adelaide
Country [3] 2236 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4326 0
Royal Melbourne Hospital
Ethics committee address [1] 4326 0
Ethics committee country [1] 4326 0
Date submitted for ethics approval [1] 4326 0
Approval date [1] 4326 0
Ethics approval number [1] 4326 0
Ethics committee name [2] 4327 0
Western Health
Ethics committee address [2] 4327 0
Ethics committee country [2] 4327 0
Date submitted for ethics approval [2] 4327 0
Approval date [2] 4327 0
Ethics approval number [2] 4327 0
Ethics committee name [3] 4328 0
Repatriation General Hospital, Adelaide
Ethics committee address [3] 4328 0
Ethics committee country [3] 4328 0
Date submitted for ethics approval [3] 4328 0
Approval date [3] 4328 0
Ethics approval number [3] 4328 0
Ethics committee name [4] 4329 0
St Margaret's Hospital, Adelaide
Ethics committee address [4] 4329 0
Ethics committee country [4] 4329 0
Date submitted for ethics approval [4] 4329 0
Approval date [4] 4329 0
Ethics approval number [4] 4329 0
Ethics committee name [5] 4330 0
Austin Health
Ethics committee address [5] 4330 0
Ethics committee country [5] 4330 0
Date submitted for ethics approval [5] 4330 0
Approval date [5] 4330 0
26/04/2006
Ethics approval number [5] 4330 0

Summary
Brief summary
This study aims to evaluate two approaches to reducing falls in people who have had a stroke, have a high risk of falls and are returning home.
Trial website
Trial related presentations / publications
Batchelor, F. A., Hill, K. D., Mackintosh, S. F., Said, C. M., & Whitehead, C. (2009). The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies. BMC Neurology, 9, 14.

Batchelor, F. A., Hill, K. D., Mackintosh, S. F., Said, C. M., & Whitehead, C. H. (2012). Effects of a multi-factorial falls prevention program in people with stroke returning home after rehabilitation: a randomized controlled trial. Archives of Physical Medicine & Rehabilitation., 93, 1648-1655.

Fryer, C. E., Mackintosh, S. F., Batchelor, F. A., Hill, K. D., & Said, C. M. (2012). The effect of limited English proficiency on falls risk and falls prevention after stroke. Age and Ageing, 41, 104-107.

Public notes

Contacts
Principal investigator
Name 27732 0
Dr Frances Batchelor
Address 27732 0
National Ageing Research Institute
PO Box 2127 The Royal Melbourne Hospital
Parkville VIC 3052
Australia
Country 27732 0
Australia
Phone 27732 0
+61383872383
Fax 27732 0
Email 27732 0
[email protected]
Contact person for public queries
Name 11107 0
Dr Frances Batchelor
Address 11107 0
National Ageing Research Institute
34-54 Poplar Rd
Parkville VIC 3052
Country 11107 0
Australia
Phone 11107 0
03 8387 2383
Fax 11107 0
03 8387 2153
Email 11107 0
[email protected]
Contact person for scientific queries
Name 2035 0
Dr Frances Batchelor
Address 2035 0
National Ageing Research Institute
34-54 Poplar Rd
Parkville VIC 3052
Country 2035 0
Australia
Phone 2035 0
+61383872383
Fax 2035 0
03 8387 2153
Email 2035 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

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