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Trial registered on ANZCTR


Registration number
ACTRN12607000206426
Ethics application status
Approved
Date submitted
10/04/2007
Date registered
13/04/2007
Date last updated
13/04/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Community Care and Hospital Based collaborative Falls Prevention Project
Scientific title
Hospital based falls prevention programs for the elderly combined with follow up community based falls prevention programs to enhance reduction of subsequent falls compared to hospital only intervention
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in the elderly living in the community 1731 0
Condition category
Condition code
Injuries and Accidents 1822 1822 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community based falls prevention follow up of people discharged from a hospital emergency department following a fall and people discharged from a hospital out patient falls prevention clinic.
The intervention group will receive up to 8 hours of support worker contact time over 2 to 4 weeks to review risk factors in the home, strategies to reduce risk factors, assistance to implement a falls action plan. This includes practical assistance e.g. visits to GP, Optometrist, Podiatrist, reinforcing awareness and reduction of risk factors.

All patients discharged from either the hospital Emergency Department or Falls Clinic have a standard Falls Action Plan to implement following the standard hospital falls intervention process. This can include a home exercise plan, organising an optometrist or podiatrist review, removing loose rugs or obtaining a non slip mat for the bathroom.

A face to face interview 4 weeks post discharge will review actions taken with the original falls action Plan of the intervention group and the control group.

At this time both groups will be provided with a falls callender to record informatin on falls. At three months all will have a phone reminder to regarding filling in the falls calendar and at 6 months a questionairre for both groups will measure qualitative and quantitative outcomes for both groups. The number of falls in the six month period from discharge to the initial 4 week post discharge will be ascertained at interview and from the initial interview at the end of a six month period of recording falls on the calendar.

Patients attending the hospital's emergency department (100) and Falls Clinic (100) who meet inclusion criteria and who consent to participate will be randomised into
control group (no community follow up) and intervention group (post discharge community follow up)
Intervention code [1] 1693 0
Prevention
Comparator / control treatment
control group (no community follow up)
Control group
Active

Outcomes
Primary outcome [1] 2554 0
Increased implementation of actions to reduce risk factors.
Timepoint [1] 2554 0
Measured by comparing the Falls Action Plan developed during the hospital intervention at 4 weeks post discharge via a face to face interview and after a further 6 months via a final questionnaire.
Primary outcome [2] 2555 0
Decreased falls over a six month post intervention period.
Timepoint [2] 2555 0
Measured by a participant record on a Falls Calendar and reported admissions to hospital as a result of a fall during the six months.
Primary outcome [3] 2556 0
The number of falls participants in the intervention and control groups will be compared as will implementation of a Falls Action Plan to reduce risk factors. The area a fall occurs such as bathroom or footpath will also be recorded.
Timepoint [3] 2556 0
The extent to which the Falls Action Plan is actioned will be measured during the interview at 4 weeks post discharge and at the 6 months post intervention questionnaire. This will also provide an indication of 'carry over' awareness and action on reducing falls post intervention.
Secondary outcome [1] 4401 0
Increased awareness of falls prevention and confidence falls are not inevitable and perception they can take action to reduce risks.
Timepoint [1] 4401 0
This will be measured at the initial interview and and the end of six months post intervention.

Eligibility
Key inclusion criteria
Presenting to the Emergency Department or Falls Clinic. live in the Perth north metropolitan hospital catchment area. live in the community.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with functinal cognitive impaiment unable to participate in the intervention e.g. dementia. People living in nursing home ineligible for community support services by Perth Home Care, HACC, VA etc.. People unable to speak or read english - study requires interview and reading /fillling in form.

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)
Subjects meeting the inclusion criteria admitted to the hospital Emergency Department or Falls Clinic who consent to participate from the time of commencement of the trial until 100 are enrolled from each Department. Details are forwarded by the hospital staff providing the standards falls intervention in either Department to an of site Project Manager who randomly allocates them to either the control group or trial intervention group. Each person is assigned a number. The research staff conducting the initial interview and phone follow up have a number for each participant but is not made aware of which group they are assigned to. Details of those in the intervention group are provided the Perth Home Care Services for Support Worker interventin by the Project Manager. Research staff collating data are provided with the numerical codes for each group at the end of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated using SPSS (statistical software) randomisation function
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Therapists providing in hospital programs are blinded as are the research staff doing interviews and phone follow up (research assistants aiding researchers in collecting and assessing the data). Participants are blinded in that that the patient information they get in hospital states they may be contacted by a staff member of Perth Home Care Services. Other than that they are advised they will be contacted for an interview and will be asked to fill in a falls calendar (all participants).
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1974 0
Government body
Name [1] 1974 0
The Australian Commonwealth Department of Health & Ageing
Country [1] 1974 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Perth Home Care Services Inc.
Address
Country
Australia
Secondary sponsor category [1] 1787 0
Hospital
Name [1] 1787 0
Sir Charles Gairdner Hospital & Silver Chain Research Department
Address [1] 1787 0
Country [1] 1787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3669 0
Silver Chain research Department
Ethics committee address [1] 3669 0
Ethics committee country [1] 3669 0
Australia
Date submitted for ethics approval [1] 3669 0
Approval date [1] 3669 0
Ethics approval number [1] 3669 0
EC app 039
Ethics committee name [2] 3670 0
Sir Charles Gairdner Hospital
Ethics committee address [2] 3670 0
Ethics committee country [2] 3670 0
Australia
Date submitted for ethics approval [2] 3670 0
Approval date [2] 3670 0
Ethics approval number [2] 3670 0
2007 - 046

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

Contacts
Principal investigator
Name 27796 0
Address 27796 0
Country 27796 0
Phone 27796 0
Fax 27796 0
Email 27796 0
Contact person for public queries
Name 10882 0
Jaye Johnson
Address 10882 0
Perth Home Care Services
30 Hasler Road
PO Box 1597
Osborne Park WA 6017
Country 10882 0
Australia
Phone 10882 0
+61 8 92047863
Fax 10882 0
Email 10882 0
jayej@phcs.org.au
Contact person for scientific queries
Name 1810 0
Jaye Johnson
Address 1810 0
Perth Home Care Services
30 Hasler Road
PO Box 1597
Osborne Park WA 6017
Country 1810 0
Australia
Phone 1810 0
+61 8 92047863
Fax 1810 0
Email 1810 0
jayej@phcs.org.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.