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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888953
First Posted: April 28, 2009
Last Update Posted: June 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fondo de Investigacion Sanitaria
Sociedad Española de Geriatría y Gerontología
Information provided by (Responsible Party):
Fundacio Salut i Envelliment UAB
  Purpose
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.

Condition Intervention
Accidental Falls Activities of Daily Living Quality of Life Self-Efficacy Other: Fall risk assessment Other: Tailored intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Estudio de Medida Del Riesgo de Caídas Orientada a la Intervención en Residencias

Resource links provided by NLM:


Further study details as provided by Fundacio Salut i Envelliment UAB:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Number of falls [ Time Frame: one year ]
    Number of falls per person/time.

  • Number of people who has a fracture as a consequence of a fall [ Time Frame: one year ]
  • Quality of life (only in residents without cognitive impairment). [ Time Frame: One year ]
  • Activities of daily living [ Time Frame: One year ]

Enrollment: 331
Study Start Date: May 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
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 Name: Mini Falls Assessment (MFA)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888953


Locations
Spain
Fundació Institut Català de l'Envelliment.
Barcelona, Spain, 08041
Sponsors and Collaborators
Fundacio Salut i Envelliment UAB
Fondo de Investigacion Sanitaria
Sociedad Española de Geriatría y Gerontología
Investigators
Principal Investigator: Antoni Salvà Casanovas, MD Fundació Institut Català de l'Envelliment
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundacio Salut i Envelliment UAB
ClinicalTrials.gov Identifier: NCT00888953     History of Changes
Other Study ID Numbers: FICE09041
PI08/90162
645H
First Submitted: April 27, 2009
First Posted: April 28, 2009
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by Fundacio Salut i Envelliment UAB:
Falls
Nursing Homes
Elderly
Prevention
Spain
Cluster Randomized Clinical Trial