Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000148774
Ethics application status
Approved
Date submitted
18/01/2013
Date registered
7/02/2013
Date last updated
7/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Te Hoe Nuku Roa - A study of the effectiveness of home fall hazard remediation together with basic home safety advice for Maori household members in New Zealand
Scientific title
A study of the effectiveness of home fall hazard remediation together with basic home safety advice on home injuries for Maori household members in New Zealand
Secondary ID [1] 281801 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unintentional injury 288128 0
Condition category
Condition code
Injuries and Accidents 288505 288505 0 0
Other injuries and accidents
Public Health 288666 288666 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One-off remediation of certain home fall hazards identified by a home hazard inspection protocol, the Healthy Housing Index. Hazards (such as steps without handrails) are remediated (e.g., by installing a handrail) at the start of the trial for the treatment group. Remediation of the hazards will typically occur within a month of the inspection. Injuries occurring in the house are monitored for about 3 years following the intervention.
Intervention code [1] 286345 0
Other interventions
Comparator / control treatment
Status quo.
After the treatment group has received the home hazard remediations and approximately three years has passed to allow an assessment of home injury rates, home fall hazards are remediated for the controls.
Control group
Active

Outcomes
Primary outcome [1] 288661 0
Count of medically treated home fall injuries as reported to the national accident insurer, the Accident Compensation Corporation (ACC).
Timepoint [1] 288661 0
During three years following start of study ACC will record data on all unintentional home fall injuries to the participants. These will be provided periodically to the research team so that telephone interviews can be used to supplement the information on the injury events.
Secondary outcome [1] 300722 0
Self-reported home injury recorded by self-completed annual questionnaire
Timepoint [1] 300722 0
Once annually for each of the three years following start of study

Eligibility
Key inclusion criteria
All occupants of owner-occupied housing with at least one Maori occupant
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those not intending to be still living at house surveyed for the full trial period

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)
Recruitment from a list of eligible households and then central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Recruitment will occur in two or more geographical regions. Randomisation will be done independently via simple randomisation using a computer software programme within each geographical stratum.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Treatment groups receive treatment at start of trial; control group receive no treatment until end of trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 4807 0
New Zealand
State/province [1] 4807 0

Funding & Sponsors
Funding source category [1] 286585 0
Government body
Name [1] 286585 0
Health Research Council
Country [1] 286585 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University Wellington
PO Box 756
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 285368 0
University
Name [1] 285368 0
Otago University
Address [1] 285368 0
Department of Public Health
Wellington School of Medicine and Health Sciences
P O Box 7343
Newtown, Wellington South, 6242
Country [1] 285368 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288660 0
The Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 288660 0
Massey University/Te Kunenga ki Purehuroa
Private Bag 11222
Palmerston North 4442
Ethics committee country [1] 288660 0
New Zealand
Date submitted for ethics approval [1] 288660 0
Approval date [1] 288660 0
07/12/2012
Ethics approval number [1] 288660 0

Summary
Brief summary
Home injury hazards are a likely to be a major cause of injury for Maori. This study will capitalise on an existing cohort of Maori houses which are participants in the Best Outcomes for Maori : Te Hoe Nuku Roa longitudinal study. Audits of 250 Maori houses will be undertaken using the Healthy Housing Index developed by members of this research team. Half of the houses will be randomly assigned to an intervention group where remediation of selected hazards will be undertaken by professional builders. At the end of the randomised control trial, the balance of the houses will be remediated. We will also assess preparedness for earthquakes and other disasters, determining structural (i.e. building) and behavioural (i.e. planning) risks for Maori.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37158 0
Dr Michael Keall
Address 37158 0
University of Otago, Wellington
Wellington School of Medicine and Health Sciences
P O Box 7343
Newtown, Wellington South, 6242
Country 37158 0
New Zealand
Phone 37158 0
+6449186794
Fax 37158 0
Email 37158 0
[email protected]
Contact person for public queries
Name 37159 0
Dr Michael Keall
Address 37159 0
University of Otago, Wellington
Wellington School of Medicine and Health Sciences
P O Box 7343
Newtown, Wellington South, 6242
Country 37159 0
New Zealand
Phone 37159 0
+6449186794
Fax 37159 0
Email 37159 0
[email protected]
Contact person for scientific queries
Name 37160 0
Dr Michael Keall
Address 37160 0
University of Otago, Wellington
Wellington School of Medicine and Health Sciences
P O Box 7343
Newtown, Wellington South, 6242
Country 37160 0
New Zealand
Phone 37160 0
+6449186794
Fax 37160 0
Email 37160 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23258Study protocolKeall M, Tupara H, Pierse N, et al. Study protocol of a randomized controlled trial of home modification to prevent home fall injuries in houses with Maori occupants. Methods Protoc 2020; 3: 71.https://www.mdpi.com/2409-9279/3/4/71 

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHome modifications to prevent home fall injuries in houses with Maori occupants (MHIPI): a randomised controlled trial.2021https://dx.doi.org/10.1016/S2468-2667%2821%2900135-3
N.B. These documents automatically identified may not have been verified by the study sponsor.