Accidental FallsNCT00217360
RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department
A study testing a customised multifactorial falls prevention program in people with Accidental Falls, run by National Ageing Research Institute, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- a customised multifactorial falls prevention program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 700 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2002to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
National Ageing Research Institute
Melbourne, Victoria, 3052
John Barlow, PhD, 83872305, j.barlow@nari.unimelb.edu.au
About this study
Official 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.
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.
Read the detailed description
Older people presenting to an Emergency Department (ED) following a fall have high injury and hospitalisation rates. They are also at high risk of further falls and other adverse outcomes. However, there is currently limited available evidence to inform best practice.
The primary aim of this project is to evaluate the effectiveness of a targeted multi-factor intervention in improving health and well being of older people who present to an ED after a fall. It also aims to identify those within this high-risk population most likely to benefit from the intervention program.
Approximately 800 people aged 60 years and over will be invited to participate at the Emergency Department from the end of September 2002. Those who are eligible to participate will have a falls risk assessment in their own home and will be required to complete a falls diary for 12 months. There is a 50/50 chance (random allocation) that participants will receive an individualised falls prevention program.
The duration of a falls risk assessment is up to 2 hours and there is no cost involved. Participation in the research program will not affect routine management from the Emergency Department.
Becoming a participant may lessen the risk of having another fall and help others as well.
- Conditions
- Accidental Falls
- Being tested
- a customised multifactorial falls prevention program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a customised multifactorial falls prevention programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of a customised multifactorial intervention in reducing falls and falls related injury rates, compared to "usual care".
Secondary outcomes (4)
To accurately identify the circumstances, contributory factors and consequences of falls for older people presenting to Emergency Departments following a fall.
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.
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.
To provide guidelines for future management of high risk older people presenting to Emergency departments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 700 participants
Sponsor and investigators
- Lead sponsor
- National Ageing Research Institute, Australia
- Sponsor type
- University, hospital or other
- Investigators
- Keith D Hill, PhD, Principal investigator, National Ageing Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217360
- Sponsor's protocol ID
- HREC 2001.034
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 4 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00217360
- Acronym / sponsor ID
- HREC 2001.034
- Conditions
- Accidental Falls
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants
- Lead sponsor
- National Ageing Research Institute, AustraliaUniversity, hospital or other
- Study start
- Dec 2002
- Study completion
- Dec 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Older people presenting to an Emergency Department (ED) following a fall have high injury and hospitalisation rates. They are also at high risk of further falls and other adverse outcomes. However, there is currently limited available evidence to inform best practice.
The primary aim of this project is to evaluate the effectiveness of a targeted multi-factor intervention in improving health and well being of older people who present to an ED after a fall. It also aims to identify those within this high-risk population most likely to benefit from the intervention program.
Approximately 800 people aged 60 years and over will be invited to participate at the Emergency Department from the end of September 2002. Those who are eligible to participate will have a falls risk assessment in their own home and will be required to complete a falls diary for 12 months. There is a 50/50 chance (random allocation) that participants will receive an individualised falls prevention program.
The duration of a falls risk assessment is up to 2 hours and there is no cost involved. Participation in the research program will not affect routine management from the Emergency Department.
Becoming a participant may lessen the risk of having another fall and help others as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a customised multifactorial falls prevention program | Behavioural | – |
Primary outcome
To evaluate the effectiveness of a customised multifactorial intervention in reducing falls and falls related injury rates, compared to "usual care".
4 secondary outcomes
To accurately identify the circumstances, contributory factors and consequences of falls for older people presenting to Emergency Departments following a fall.
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.
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.
To provide guidelines for future management of high risk older people presenting to Emergency departments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2006.
Related trials for Accidental Falls
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of the PPAL
Age Problems
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith D Hill, PhD principal investigator
National Ageing Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a customised multifactorial falls prevention program in people with Accidental Falls, run by National Ageing Research Institute, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Blackberry, MB, PhD (83872614, i.blackberry@nari.unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of a customised multifactorial intervention in reducing falls and falls related injury rates, compared to "usual care".. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2006.