Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000779279
Ethics application status
Approved
Date submitted
1/09/2009
Date registered
8/09/2009
Date last updated
8/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Home Injury Prevention Intervention (HIPI)
Scientific title
Randomised controlled trial of medically treated home injury due to falls amongst low income occupants of Taranaki housing. The treatment studied is home fall hazard remediation together with basic home safety advice.
Secondary ID [1] 908 0
09/071AR
Universal Trial Number (UTN)
Trial acronym
HIPI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medically treated home injury 237118 0
Condition category
Condition code
Injuries and Accidents 237444 237444 0 0
Other injuries and accidents

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.
Intervention code [1] 236839 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] 238246 0
Count of medically treated home injuries
Timepoint [1] 238246 0
During three years following start of study
Secondary outcome [1] 244583 0
Self-reported home injury recorded by self-completed annual questionnaire
Timepoint [1] 244583 0
During three years following start of study
Secondary outcome [2] 244584 0
Acceptability of remediation to householder as indicated by remediations declined when house is visited by tradesmen and by telephone interview
Timepoint [2] 244584 0
Within a year of start of study

Eligibility
Key inclusion criteria
Occupants of Taranaki Region housing constructed before 1978 and owned by a Community Services Card holder (entitled to government assistance due to low income or pension)
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)
Stratified allocation using age as strata in two groups: households with member aged 55 plus at start of trial; other households.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
Recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 1863 0
New Zealand
State/province [1] 1863 0
Central Region

Funding & Sponsors
Funding source category [1] 237228 0
Government body
Name [1] 237228 0
Health Research Council of New Zealand
Country [1] 237228 0
New Zealand
Primary sponsor type
University
Name
Otago University
Address
Department of Public Health
Wellington School of Medicine and Health Sciences
P O Box 7343
Newtown, Wellington South, 6242
Country
New Zealand
Secondary sponsor category [1] 236719 0
None
Name [1] 236719 0
Address [1] 236719 0
Country [1] 236719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239329 0
Central Region Ethics committee
Ethics committee address [1] 239329 0
System Improvement Group
Population Health Directorate
Ministry of Health
Ethics committee country [1] 239329 0
New Zealand
Date submitted for ethics approval [1] 239329 0
Approval date [1] 239329 0
09/06/2009
Ethics approval number [1] 239329 0
Ethics committee name [2] 239473 0
Central Region Ethics Committee
Ethics committee address [2] 239473 0
Population Directorate
Ministry of Health
Ethics committee country [2] 239473 0
New Zealand
Date submitted for ethics approval [2] 239473 0
Approval date [2] 239473 0
09/06/2009
Ethics approval number [2] 239473 0
CEN/09/06/035

Summary
Brief summary
There are 600,000 people injured at home annually, including over 5,000 serious falls resulting in hospitalisation. This research uses a randomised controlled trial (RCT) of 1,000 households in Taranaki. Our pilot study indicated that fixing fall hazards will reduce injury rates. The stage is now set for a highly effective RCT. We have developed strong community relationships, leading to excellent cooperation rates and high quality baseline injury and health data. All 1,000 homes have been fully assessed for injury hazards using our standardised Healthy Housing Index.
Consistent with our community focus, we will remediate home hazards for the control group once the study is completed and report back results to the community. We will also carry out a full cost-benefit appraisal of the intervention to assist translation of our research findings for decision makers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29814 0
Address 29814 0
Country 29814 0
Phone 29814 0
Fax 29814 0
Email 29814 0
Contact person for public queries
Name 13061 0
Dr Michael Keall
Address 13061 0
Department of Public Health
Wellington School of Medicine and Health Sciences
P O Box 7343
Newtown, Wellington South, 6242
Country 13061 0
New Zealand
Phone 13061 0
+644 918 6794
Fax 13061 0
+644 3895319
Email 13061 0
[email protected]
Contact person for scientific queries
Name 3989 0
Dr Michael Keall
Address 3989 0
Department of Public Health
Wellington School of Medicine and Health Sciences
P O Box 7343
Newtown, Wellington South, 6242
Country 3989 0
New Zealand
Phone 3989 0
+644 918 6794
Fax 3989 0
+644 3895319
Email 3989 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.