Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000352404
Ethics application status
Approved
Date submitted
28/06/2007
Date registered
29/06/2007
Date last updated
29/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving adherence with the use of hip protectors amongst older people
Scientific title
Older people and hip protectors - increasing adherence to prevent hip fractures
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 1909 0
Condition category
Condition code
Injuries and Accidents 2000 2000 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hip protectors which are plastic shields or foam pads worn over the hip in specially adapted underwear are expected to be worn at all times during the day. The duration of the study is six months. Intervention 1 - provision of hip protectors wtithout cost; Intervention 2 - provision of strategy to assist with adherence (which includes education, a demonstration of the use of the hip protectors, and the ability to choose the type of hip protector to be worn) plus provision of hip protectors without cost; Control - provision of brochure about hip protectors. There are three settings for the trial - for community dwelling older people there is individual randomisation; while for older people recruited in hospital or in residential aged care facilities there is cluster randomisation.
Intervention code [1] 1858 0
Prevention
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2822 0
Adherence with the use of hip protectors
Timepoint [1] 2822 0
At 3 and 6 months
Secondary outcome [1] 4763 0
Falls, fractures, hospitalisation
Timepoint [1] 4763 0
Assessed over the six month duration of the study, based on report at 3 and 6 months.
Secondary outcome [2] 4764 0
Activities of daily living functioning, health related quality of life.
Timepoint [2] 4764 0
At 3 and 6 months.

Eligibility
Key inclusion criteria
Old subjects likely to survive for at least 12 months; at least one hip without previous fracture or arthroplasty.
Minimum age
75 Years
Maximum age
No limit
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)
Concealed - sealed opaque numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessor blinded
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
714
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2141 0
Government body
Name [1] 2141 0
National Health and Medical Research Council
Country [1] 2141 0
Australia
Primary sponsor type
Individual
Name
Ian Cameron
Address
Country
Secondary sponsor category [1] 1945 0
Individual
Name [1] 1945 0
Susan Kurrle
Address [1] 1945 0
Country [1] 1945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3937 0
Royal Rehabilitation Centre Sydney
Ethics committee address [1] 3937 0
Ethics committee country [1] 3937 0
Australia
Date submitted for ethics approval [1] 3937 0
Approval date [1] 3937 0
12/10/2004
Ethics approval number [1] 3937 0
04/19
Ethics committee name [2] 3938 0
Northern Sydney Area Health Service
Ethics committee address [2] 3938 0
Ethics committee country [2] 3938 0
Australia
Date submitted for ethics approval [2] 3938 0
Approval date [2] 3938 0
13/09/2004
Ethics approval number [2] 3938 0
0407-160M
Ethics committee name [3] 3939 0
University of Sydney
Ethics committee address [3] 3939 0
Ethics committee country [3] 3939 0
Australia
Date submitted for ethics approval [3] 3939 0
Approval date [3] 3939 0
01/11/2004
Ethics approval number [3] 3939 0
7692

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

Contacts
Principal investigator
Name 27672 0
Address 27672 0
Country 27672 0
Phone 27672 0
Fax 27672 0
Email 27672 0
Contact person for public queries
Name 11047 0
Ian Cameron
Address 11047 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6
Ryde NSW 1680
Country 11047 0
Australia
Phone 11047 0
+61 2 98089236
Fax 11047 0
+61 2 98099037
Email 11047 0
[email protected]
Contact person for scientific queries
Name 1975 0
Ian Cameron
Address 1975 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6
Ryde NSW 1680
Country 1975 0
Australia
Phone 1975 0
+61 2 98089236
Fax 1975 0
+61 2 98099037
Email 1975 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.