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RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department

Primary Purpose

Accidental Falls

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
a customised multifactorial falls prevention program
Sponsored by
National Ageing Research Institute, Australia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Accidental Falls

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • National Ageing Research InstituteRecruiting

Outcomes

Primary Outcome Measures

To evaluate the effectiveness of a customised multifactorial intervention in reducing falls and falls related injury rates, compared to "usual care".

Secondary Outcome Measures

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.

Full Information

First Posted
September 16, 2005
Last Updated
October 3, 2006
Sponsor
National Ageing Research Institute, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00217360
Brief Title
RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Ageing Research Institute, Australia

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
700 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
a customised multifactorial falls prevention program
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of a customised multifactorial intervention in reducing falls and falls related injury rates, compared to "usual care".
Secondary Outcome Measure Information:
Title
To accurately identify the circumstances, contributory factors and consequences of falls for older people presenting to Emergency Departments following a fall.
Title
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.
Title
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.
Title
To provide guidelines for future management of high risk older people presenting to Emergency departments.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Blackberry, MB, PhD
Phone
83872614
Email
i.blackberry@nari.unimelb.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith D Hill, PhD
Organizational Affiliation
National Ageing Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Ageing Research Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Barlow, PhD
Phone
83872305
Email
j.barlow@nari.unimelb.edu.au

12. IPD Sharing Statement

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RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department

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