RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department
Recruitment status was Recruiting
|First Received Date ICMJE||September 16, 2005|
|Last Updated Date||October 3, 2006|
|Start Date ICMJE||December 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To evaluate the effectiveness of a customised multifactorial intervention in reducing falls and falls related injury rates, compared to "usual care".|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00217360 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department|
|Official Title ICMJE||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.
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 Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Condition ICMJE||Accidental Falls|
|Intervention ICMJE||Behavioral: a customised multifactorial falls prevention program|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Completion Date||December 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||60 Years and older|
|Accepts Healthy Volunteers||Not Provided|
|Location Countries ICMJE||Australia|
|NCT Number ICMJE||NCT00217360|
|Other Study ID Numbers ICMJE||HREC 2001.034|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Ageing Research Institute, Australia|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Ageing Research Institute, Australia|
|Verification Date||September 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP