Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000064303
Ethics application status
Approved
Date submitted
25/01/2008
Date registered
1/02/2008
Date last updated
1/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of multimedia patient education approaches to preventing in-hospital falls – Pre-test survey of education materials.
Scientific title
Randomised controlled trial of multimedia patient education approaches to preventing in-hospital falls in the elderly– Pre-test survey of education materials.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental Falls 2666 0
Condition category
Condition code
Public Health 2786 2786 0 0
Health promotion/education
Injuries and Accidents 2787 2787 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in group one will watch a DVD which will educate patient on how to minimise falls risk in hospital. In addition patients will receive their usual care.
Patients in group two will read a booklet which will educate patient on how to minimise falls risk in hospital. In addition patients will receive their usual care.
Intervention code [1] 2408 0
Prevention
Comparator / control treatment
There are two groups and each will receive a different intervention. Both groups will recieve usual care. Both groups are Active.
On the Orthopaedic Unit at Princess Alexandra Hospital (PAH) and on the Medical Ward at Swan Districts Hospital(SDH) this consists of 24 hour availability of nursing and medical care, daily physiotherapy, and referrals to other allied health professionals as required. On the Geriatric Aged and Rehabilitation Unit at PAH and at the Restorative Unit at SDH, there are also daily occupational therapy sessions, and social work assessment and management provided. A local falls risk assessment tool that has not been validated is used and orange arm bands are provided to patients assessed as being at high risk for falls at the PAH and a local falls risk screening tool is used by the nursing staff at SDH on patient’s admission.
Control group
Active

Outcomes
Primary outcome [1] 3744 0
Accidental falls (event rate of falls measured in events per time units) as measured during the participants period of inpatient hospital care. (The start of this observation period will be taken from the point of randomisation rather than the date of admission as it may take approximately 2 days to gain consent for participation, particularly where family members have to be approached).
Timepoint [1] 3744 0
From time of enrolment to discharge from hospital
Secondary outcome [1] 6326 0
Rate of fall-related injury during the participants in-hospital admission.
Timepoint [1] 6326 0
From time of enrolment to discharge from hospital.

Eligibility
Key inclusion criteria
Patients admitted to participating wards who are over 60 years old and able to participate voluntarily and provide signed informed consent or access to an appropriate family member/guardian or carer who can provide signed informed consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age < than 60 years

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participant will be approached for consent by a researcher. Once consent is provided the baseline data will be collected. The researcher will then open a randomly ordered opaque envelope containing the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be developed by the project principal investigator using a computerised random number generator who will then produce the opaque sealed envelopes that contain the random allocation sequence. The project principal investigator will not be involved in participant recruitment or opening the opaque envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 562 0
6055
Recruitment postcode(s) [2] 563 0
6056
Recruitment postcode(s) [3] 564 0
4102

Funding & Sponsors
Funding source category [1] 3022 0
Government body
Name [1] 3022 0
National Health and Medical Research Council
Country [1] 3022 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland
Faculty of Health and Rehabilitation Sciences
Therapies Annexe Level 8
St Lucia Brisbane 4072
Country
Australia
Secondary sponsor category [1] 2728 0
None
Name [1] 2728 0
Address [1] 2728 0
Country [1] 2728 0
Other collaborator category [1] 183 0
Individual
Name [1] 183 0
A/Pr Kryss McKenna
Address [1] 183 0
c/o School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia QLD 4067.
Country [1] 183 0
Australia
Other collaborator category [2] 184 0
Individual
Name [2] 184 0
Dr Sandra Brauer
Address [2] 184 0
c/o School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia QLD 4067.
Country [2] 184 0
Australia
Other collaborator category [3] 185 0
Individual
Name [3] 185 0
Dr Tammy Hoffmann
Address [3] 185 0
c/o School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia QLD 4067.
Country [3] 185 0
Australia
Other collaborator category [4] 186 0
Individual
Name [4] 186 0
Dr Tammy Hoffmann
Address [4] 186 0
c/o School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia QLD 4067.
Country [4] 186 0
Australia
Other collaborator category [5] 187 0
Individual
Name [5] 187 0
Dr Christopher Beer
Address [5] 187 0
Head of Department Aged Care
Swan Kalamunda Health Service
Eveline Road,
Middle Swan WA 6056
|
Country [5] 187 0
Australia
Other collaborator category [6] 188 0
Individual
Name [6] 188 0
Pr Keith Hill
Address [6] 188 0
National Ageing Research Institute Incorporated
34-54 Poplar Road (via Gate 4)
Parkville
Victoria 3052
Country [6] 188 0
Australia
Other collaborator category [7] 189 0
Individual
Name [7] 189 0
Dr David Oliver
Address [7] 189 0
University of Reading, Institute of Health Sciences,
London
Road, Reading,
Berkshire, UK
Country [7] 189 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4977 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 4977 0
Ethics committee country [1] 4977 0
Australia
Date submitted for ethics approval [1] 4977 0
Approval date [1] 4977 0
Ethics approval number [1] 4977 0
2006/173
Ethics committee name [2] 4978 0
Medical Research Ethics Committee, The University of Queensland
Ethics committee address [2] 4978 0
Ethics committee country [2] 4978 0
Australia
Date submitted for ethics approval [2] 4978 0
Approval date [2] 4978 0
15/11/2007
Ethics approval number [2] 4978 0
2007000148

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

Contacts
Principal investigator
Name 28268 0
Address 28268 0
Country 28268 0
Phone 28268 0
Fax 28268 0
Email 28268 0
Contact person for public queries
Name 11425 0
Dr Terry P. Haines
Address 11425 0
c/o physiotherapy department, GARU, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba QLD 4102
Country 11425 0
Australia
Phone 11425 0
61 7 3240 6713
Fax 11425 0
61 7 3240 7207
Email 11425 0
[email protected]>
Contact person for scientific queries
Name 2353 0
Dr Terry P. Haines
Address 2353 0
c/o physiotherapy department, GARU, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba QLD 4102
Country 2353 0
Australia
Phone 2353 0
61 7 3240 6713
Fax 2353 0
61 7 3240 7207
Email 2353 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.