NCT00226486

Brief Summary

Falls and injurious falls are common among elderly people. The aim of the study is to test a model of multifactorial fall intervention in a Danish population of elderly sustaining a fall. Focus is on prevention of further falls, patients views on fall prevention and a cost-effectiveness analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
392

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

2.5 years

First QC Date

September 23, 2005

Last Update Submit

August 20, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of falls and injurious falls in 12 months

Secondary Outcomes (5)

  • Health related Quality of Life

  • Fear of falling

  • Dependence

  • Use of hospital, primary care etc.

  • Mortality

Study Arms (2)

1

EXPERIMENTAL

Identification of individual risk factors for falls and specified intervention aimed diminishing these risk factors in the individual.

Other: multifactorial intervention

2

PLACEBO COMPARATOR

Usual care

Other: Usual care

Interventions

Identification of medical, cardiovascular, physical risk factors for falls; e.g. vision, drug-use, depression, carotid sinus syndrome, orthostatic hypotension, etc. Individual intervention; treatment of disease, drug review, pacemaker, exercises, new glasses, all if indicated.

1

No intervention, but ususal care after an accidental fall.

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years old or older
  • Having been treated in emergency department or submitted to hospital after a fall
  • Living in the Glostrup area.

You may not qualify if:

  • Fall due to strong external force, new apoplexia cerebri, epileptic seizure, alcohol intoxication.
  • Known cognitive impairment
  • Not able to walk prior to fall
  • Living in institution
  • Planned geriatric intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Geriatrics, Amtssygehuset i Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • Vind AB, Andersen HE, Pedersen KD, Joergensen T, Schwarz P. Effect of a program of multifactorial fall prevention on health-related quality of life, functional ability, fear of falling and psychological well-being. A randomized controlled trial. Aging Clin Exp Res. 2010 Jun;22(3):249-54. doi: 10.1007/BF03324804. Epub 2009 Nov 17.

Study Officials

  • Ane B Vind, Dr.

    Glostrup University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 21, 2008

Record last verified: 2008-08

Locations