Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001178538
Ethics application status
Approved
Date submitted
21/10/2015
Date registered
3/11/2015
Date last updated
3/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the installation of safety features to access steps to homes in Wellington and New Plymouth
Scientific title
Effect of the installation of handrails and high-visibility slip-resistant edgings to access steps. on rates of medically treated home injury due to falls among the general population who occupy houses with a flight of >4 and less than or equal to 15 access steps to the front door in the Wellington Region and New Plymouth.
Secondary ID [1] 287713 0
nil
Universal Trial Number (UTN)
Trial acronym
SOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medically treated injury 296550 0
falls 296597 0
Condition category
Condition code
Injuries and Accidents 296812 296812 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Installation of safety features on access steps to home. These consist of handrails and step edgings (where possible) that are slip-resistant and high-visibility. The outcomes will be assessed based on an anonymised address match, so as long as addresses of injured people are recorded correctly, the exposures will be appropriately assigned during analysis.
Intervention code [1] 293103 0
Prevention
Comparator / control treatment
Status quo: absence of safety features on access steps to home
Control group
Active

Outcomes
Primary outcome [1] 296406 0
Count of medically treated home fall injuries. These will be identified from ACC records by anonymously matching addresses of injured people receiving ACC subsidy for medical treatment to the addresses of houses in the study.. This match will be undertaken by ACC staff, not by the study team.
Timepoint [1] 296406 0
3.5 years after treatment (or for controls: 3.5 years after median point of treatment for treatment group)
Secondary outcome [1] 318363 0
Count of medically treated home injuries due to falls where the word “step” appears in the injury description in ACC records. Relevant injuries will be identified by anonymously matching addresses of injured people receiving ACC subsidy for medical treatment to the houses in the study.. This match will be undertaken by ACC staff, not by the study team.
Timepoint [1] 318363 0
3.5 years after treatment (or for controls: 3.5 years after median point of treatment for treatment group)
Secondary outcome [2] 318364 0
Assessment of safety benefits only for those who received the modifications (excluding those in treatment group who did not consent to the modifications). Relevant injuries will be identified by anonymously matching addresses of injured people receiving ACC subsidy for medical treatment to the houses in the study.
Timepoint [2] 318364 0
3.5 years after treatment

Eligibility
Key inclusion criteria
Houses in Wellington Region (New Zealand) or New Plymouth, with access steps to front door in flights of between 5 and 15 steps but where there are not more than 20 steps in total to the front door. These steps lack handrails and high-visibility slip-resistant nosings.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Houses not fulfilling inclusion 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)
The people who determined if a house was eligible for inclusion in the trial were unaware, when identifying houses, to which group the house would be allocated. After lists of eligible houses had been compiled, randomisation was done at a central administration site by computer..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Within geographical areas, a random number is generated and attached to each eligible address. The lowest one third of such numbers identify which addresses receive the modifications (the treatment).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Negative Binomial Generalised Linear Models will be fitted to estimate fall rates per household with outcome being counts of fall injuries and covariates address-specific falls in the year prior to the study, number of steps and a group identifier (treatment or control). A sub-analysis will be conducted to identify any interactions between the group identifier and (i) prior falls (ii) number of steps in two strata: 5-8 and 9-15.

On the basis of a previous study (the HIPI study) and analysis of new ACC claims for 2012 classified by the setting of the injury, injuries on steps can be estimated to occur in at least 6% of the population of houses studied per year, or 18% over three years, over which timespan injuries will be monitored for this study. For the power calculation, we have used 18% as the baseline rate. This may be conservative given that we will focus on houses with at least five steps with identified hazards, which we assume will pose a greater injury risk.

The expected relative risk of these injuries for the treated houses relative to the control houses can be expected to be about 0.61 (a reduction in risk of 39%), based on HIPI results for specific injuries (those injuries most likely to be influenced by the modifications made in that study). We have conservatively used 0.65 (a reduction in risk of 35%) in our power calculations. For a study with 400 houses and 800 control houses with a three-year rate of falls per control house of 0.18 and a true relative risk of injury of 0.65, we will be able to reject the null hypothesis that this relative risk equals one with 82% power, using a Type I error probability of 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/10/2015
Date of last participant enrolment
Anticipated
11/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment outside Australia
Country [1] 7264 0
New Zealand
State/province [1] 7264 0
Wellington and Taranaki

Funding & Sponsors
Funding source category [1] 292262 0
Government body
Name [1] 292262 0
Health Research Council of New Zealand
Country [1] 292262 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 290935 0
None
Name [1] 290935 0
Address [1] 290935 0
Country [1] 290935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293729 0
University of Otago Human Ethics Committee
Ethics committee address [1] 293729 0
Academic Services
Clocktower Building
University of Otago,
PO Box 56
Dunedin, 9054
New Zealand
Ethics committee country [1] 293729 0
New Zealand
Date submitted for ethics approval [1] 293729 0
01/07/2015
Approval date [1] 293729 0
13/07/2015
Ethics approval number [1] 293729 0
D15/205

Summary
Brief summary
Around 1,200 addresses will be identified in the Wellington Region and New Plymouth where there are more than 5 access steps and neither handrails nor step edgings (nosings). From these, 400 addresses will be randomly sampled to receive modifications at no cost to the occupants or owners. The modifications will consist of the provision of handrails and step edgings and minor step repairs where necessary.
An address match for the treatment group homes and the control homes in the same area will then be conducted by the national injury insurer, ACC, to identify falls in the home that received ACC-funded medical treatment over the period before modification and after modification of the addresses in the study. Analysis will then be conducted on anonymised counts identified only by the general location, age group and sex of the injured people, and a random digit per address to identify falls happening at the same address (so that clustering by household can be accommodated in the analysis). The main analysis will be according to “Intention to Treat” principles, where injury rates for all homes allocated to the treatment group are compared to the controls. A secondary analysis will consider the safety benefits only for homes that consented to have the modifications done.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61098 0
A/Prof Michael Keall
Address 61098 0
University of Otago, Wellington
PO Box 7343, Wellington South 6242
Country 61098 0
New Zealand
Phone 61098 0
+644 918 6794
Fax 61098 0
+644 389 5319
Email 61098 0
[email protected]
Contact person for public queries
Name 61099 0
Michael Keall
Address 61099 0
University of Otago, Wellington
PO Box 7343, Wellington South 6242
Country 61099 0
New Zealand
Phone 61099 0
+644 918 6794
Fax 61099 0
+644 389 5319
Email 61099 0
[email protected]
Contact person for scientific queries
Name 61100 0
Michael Keall
Address 61100 0
University of Otago, Wellington
PO Box 7343, Wellington South 6242
Country 61100 0
New Zealand
Phone 61100 0
+644 918 6794
Fax 61100 0
+644 389 5319
Email 61100 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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