Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00217360




Registration number
NCT00217360
Ethics application status
Date submitted
16/09/2005
Date registered
22/09/2005
Date last updated
4/10/2006

Titles & IDs
Public title
RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department
Scientific title
RCT to Evaluate the Effectiveness of a Targeted and Personalised Multifactorial Program to Reduce Further Falls and Injuries for Community-Dwelling Older Fallers Presenting to and Being Discharged Directly From an Emergency Department.
Secondary ID [1] 0 0
HREC 2001.034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental Falls 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the effectiveness of a customised multifactorial intervention in reducing falls and falls related injury rates, compared to "usual care".
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To accurately identify the circumstances, contributory factors and consequences of falls for older people presenting to Emergency Departments following a fall.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
To evaluate the effectiveness of the intervention program in improving secondary health and well-being measures, including physical, psychological (fear of falling, depression), and quality of life indices.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
To identify the physical, functional, and cognitive (executive function) parameters most strongly associated with good outcomeTo conduct an economic evaluation of the interventions and outcomes.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
To provide guidelines for future management of high risk older people presenting to Emergency departments.
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
* presenting to the Emergency Department with the primary cause of presentation being a fall; aged 60 years or older;
* discharged directly home following emergency care; living in the community or a retirement village; willing to take part in the study;
* able to provide informed consent or has consent provided by a third party; able to comply with simple instructions;
* able to walk independently indoors with or without a gait aid.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
National Ageing Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
National Ageing Research Institute, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This project is called "Falls Aren't Us" and aimed at evaluating the effectiveness of a customised falls prevention program for people aged 60 and over who were presented to the hospital Emergency Department following a fall and being discharged home. Recruitment for this randomized controlled trial has commenced in late December 2002 from several major public hospitals in the western, southern, and northern parts of Melbourne Metropolitan Region. Consented participants will receive a comprehensive falls risk assessment within one week of being discharged home from the Emergency Department and at twelve month following this initial assessment. Their falls risks will be monitored for twelve months through a falls diary. Following randomization, participants in the intervention group will receive a customised falls prevention program in addition to the usual care being put in place from the hospital Emergency Department.
Trial website
https://clinicaltrials.gov/study/NCT00217360
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keith D Hill, PhD
Address 0 0
National Ageing Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Irene Blackberry, MB, PhD
Address 0 0
Country 0 0
Phone 0 0
83872614
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00217360