NCT01279525

Brief Summary

The purpose of this study is to determine the effectiveness of a multifactorial intervention program to prevent falls among the elderly as compared to a brief intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
404

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 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

January 1, 2005

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

First QC Date

January 18, 2011

Last Update Submit

January 18, 2011

Conditions

Patient Fall

Keywords

FallsPreventionElderly

Outcome Measures

Primary Outcomes (1)

  • fall incidence rate

Study Arms (1)

Multifactorial intervention

EXPERIMENTAL

Multifactorial intervention to prevent falls

Device: multifactorial

Interventions

multifactorialDEVICE

individual advice, information leaflet, physical exercise workshop and home visits

Multifactorial intervention

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients residing in the community

You may not qualify if:

  • to be institutionalized
  • Immobilized or bedridden
  • Present a terminal disease or severe psychiatric illness
  • Have contraindications to physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad Docente de Medicina Familiar y Comunitaria

Córdoba, Cordoba, 14011, Spain

Location

Related Publications (1)

  • Perula LA, Varas-Fabra F, Rodriguez V, Ruiz-Moral R, Fernandez JA, Gonzalez J, Perula CJ, Roldan AM, de Dios C; EPICA Study Collaborative Group. Effectiveness of a multifactorial intervention program to reduce falls incidence among community-living older adults: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Oct;93(10):1677-84. doi: 10.1016/j.apmr.2012.03.035. Epub 2012 May 15.

    PMID: 22609117DERIVED

Study Officials

  • Luis A Pérula, Ph D

    Andalusian Health Service

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

January 1, 2005

Study Completion

January 1, 2011

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

ES(1)