Nursing Homes Study of Fall Risk Assessment Oriented to Intervention (EMERCOIR)

June 12, 2013 updated by: Fundacio Salut i Envelliment UAB

Estudio de Medida Del Riesgo de Caídas Orientada a la Intervención en Residencias

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Falls are the most frequent accidents in nursing homes, affecting more than a third of residents each year. Up to 10% of fallers require hospitalization or suffer a fracture. Psychological consequences affects between 20 and 80% of fallers, which suffer a lack of self-confidence that leads to reduction of activities and an increase of the dependence in activities of daily living.

Not all the residents have the same risk, and each person can have more than one risk factor that can be identified (previous falls, self confidence, weakness, gait disorders, dizziness, cognitive impairment, etc).

Identification of risk factors is the first step to reduce falls, but is not enough by itself. For this reason, interventions directed towards the correction of identified risk factors are required. In this setting, multifactorial interventions are the most successful to reduce falls numbers and its consequences.

As individual randomization of residents presents important inconveniences (group contamination, control arm residents could felt discriminated), we will randomized nursing homes to each group.

Study Type

Interventional

Enrollment (Actual)

331

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Fundació Institut Català de l'Envelliment.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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 assessment
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)
Other Names:
  • Mini Falls Assessment (MFA)
Other: Tailored intervention
Induction of an intervention for each identified risk factor. If is possible the intervention will be directed towards the treatment of the underlying cause.
Other: Control
Residents living in nursing homes allocated to control group. Assessment of risk factors. Receive the usual attention.
Other: Fall risk assessment
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)
Other Names:
  • Mini Falls Assessment (MFA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of fallers
Time Frame: one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of falls
Time Frame: one year
Number of falls per person/time.
one year
Number of people who has a fracture as a consequence of a fall
Time Frame: one year
one year
Quality of life (only in residents without cognitive impairment).
Time Frame: One year
One year
Activities of daily living
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Salut i Envelliment UAB

Collaborators

Fondo de Investigacion Sanitaria
Sociedad Española de Geriatría y Gerontología

Investigators

  • Principal Investigator: Antoni Salvà Casanovas, MD, Fundació Institut Català de l'Envelliment

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FICE09041
  • PI08/90162
  • 645H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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