Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000467639
Ethics application status
Approved
Date submitted
11/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing falls in hospital: a randomised controlled trial of patient and staff training
Scientific title
Preventing falls among older hospital inpatients: a randomised controlled trial of patient and staff training
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older people 586 0
Condition category
Condition code
Public Health 658 658 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 months of patient and staff training provided by a physiotherapist and registered nurse.
Intervention code [1] 458 0
Prevention
Comparator / control treatment
Usual care
Control group
Active

Outcomes
Primary outcome [1] 783 0
Falls rates during the three-month study period.
Timepoint [1] 783 0
Secondary outcome [1] 1593 0
Staff costs during the three-month study period.
Timepoint [1] 1593 0

Eligibility
Key inclusion criteria
Randomisation is by ward rather than individual and all patients on participating wards are study subjects.
Minimum age
Not stated
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)
Pairs of wards are allocated to intervention or control conditions when an independent person opens one of two opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One ward from each pair allocated to intervention and control group by the opening of one of two opaque envelopes- one with the word intervention inside it and one with the word control inside it, with no restriction
Masking / blinding
Open (masking not 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
1/10/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 727 0
Government body
Name [1] 727 0
NHMRC Health Research Partnership Grant
Country [1] 727 0
Australia
Primary sponsor type
Other
Name
Prince of Wales Medical Research Institute
Address
Country
Australia
Secondary sponsor category [1] 603 0
None
Name [1] 603 0
None
Address [1] 603 0
Country [1] 603 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35925 0
Address 35925 0
Country 35925 0
Phone 35925 0
Fax 35925 0
Email 35925 0
Contact person for public queries
Name 9647 0
Dr Catherine Sherrington
Address 9647 0
Medical Research Institute
Prince of Wales
Barker St
Randwick NSW 2031
Country 9647 0
Australia
Phone 9647 0
+61 2 93991063
Fax 9647 0
+61 2 93991005
Email 9647 0
c.sherrington@unsw.edu.au
Contact person for scientific queries
Name 575 0
A/Prof Stephen Lord
Address 575 0
Medical Research Institute
Prince of Wales
Barker St
Randwick NSW 2031
Country 575 0
Australia
Phone 575 0
+61 2 93991061
Fax 575 0
+61 2 9399 1005
Email 575 0
s.lord@unsw.edu.au

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.