NCT00888953

Brief Summary

The aim of the study is to establish the impact of a falls screening questionnaire in the adoption of preventive interventions and eventually in the reduction of falls and its consequences in elder people living in nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
331

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

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

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

2.9 years

First QC Date

April 27, 2009

Last Update Submit

June 12, 2013

Conditions

Accidental FallsActivities of Daily LivingQuality of LifeSelf-Efficacy

Keywords

FallsNursing HomesElderlyPreventionSpainCluster Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • Number of fallers

    People who at least have one fall during the follow-up period. Fall:unexpected event in which the participants come to rest on the ground, floor, or lower level

    one year

Secondary Outcomes (4)

  • Number of falls

    one year

  • Number of people who has a fracture as a consequence of a fall

    one year

  • Quality of life (only in residents without cognitive impairment).

    One year

  • Activities of daily living

    One year

Study Arms (2)

Intervention

EXPERIMENTAL

Residents living in nursing homes allocated to intervention group. Assessment of risk factors. Implementation of a multifactorial tailored program to prevent falls.

Other: Fall risk assessmentOther: Tailored intervention

Control

OTHER

Residents living in nursing homes allocated to control group. Assessment of risk factors. Receive the usual attention.

Other: Fall risk assessment

Interventions

Fall risk assessmentOTHER

Assessment of presence of risk factors (previous falls, self efficacy, balance and gait disorders, weakness, daily living impairment, limb pain, foot problems, dizziness, cognitive impairment, vision impairment, depression, urinary incontinence, heart disease, polimedication and consumption of neuroleptics and psychotropic medication)

Also known as: Mini Falls Assessment (MFA)
ControlIntervention
Tailored interventionOTHER

Induction of an intervention for each identified risk factor. If is possible the intervention will be directed towards the treatment of the underlying cause.

Intervention

Eligibility Criteria

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

You may qualify if:

  • People with or without cognitive impairment living indefinitely in a nursing home place
  • Able to walk with or without any kind of help or able to self transfer (as defined in category d420 of the WHO International Classification of Functioning, Disability and Health) without help
  • Give their consent (or the legal guardian in case of cognitive impairment).

You may not qualify if:

  • Terminal illness (expected death before 6 months).
  • Occupying temporarily a nursing home place (convalescence period) or another kind of place(day center, long term care, etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundació Institut Català de l'Envelliment.

Barcelona, Barcelona, 08041, Spain

Location

Related Publications (1)

  • Salva A, Rojano X, Coll-Planas L, Domenech S, Roque I Figuls M. [Randomized clinical trial of a fall-prevention strategy for institutionalized elderly based on the Mini Falls Assessment Instrument]. Rev Esp Geriatr Gerontol. 2016 Jan-Feb;51(1):18-24. doi: 10.1016/j.regg.2015.02.001. Epub 2015 Mar 14. Spanish.

    PMID: 25777945DERIVED

Study Officials

  • Antoni Salvà Casanovas, MD

    Fundació Institut Català de l'Envelliment

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

ES(1)