NCT00217360

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 4, 2006

Status Verified

September 1, 2005

First QC Date

September 16, 2005

Last Update Submit

October 3, 2006

Conditions

Accidental Falls

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

a customised multifactorial falls prevention programBEHAVIORAL

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Ageing Research Institute

Melbourne, Victoria, 3052, Australia

RECRUITING

Study Officials

  • Keith D Hill, PhD

    National Ageing Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Blackberry, MB, PhD

CONTACT

83872614i.blackberry@nari.unimelb.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

December 1, 2002

Study Completion

December 1, 2006

Last Updated

October 4, 2006

Record last verified: 2005-09

Locations

AU(1)