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

This study has been completed.
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Sociedad Española de Geriatría y Gerontología
Information provided by (Responsible Party):
Fundacio Institut Catala de l'Envelliment
ClinicalTrials.gov Identifier:
NCT00888953
First received: April 27, 2009
Last updated: June 12, 2013
Last verified: June 2013

April 27, 2009
June 12, 2013
May 2009
April 2012   (final data collection date for primary outcome measure)
Number of fallers [ Time Frame: one year ] [ Designated as safety issue: No ]
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
Number of fallers [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00888953 on ClinicalTrials.gov Archive Site
  • Number of falls [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of falls per person/time.
  • Number of people who has a fracture as a consequence of a fall [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Quality of life (only in residents without cognitive impairment). [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Activities of daily living [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Number of falls [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Number of people who has a fracture as a consequence of a fall [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Quality of life (only in residents without cognitive impairment). [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Activities of daily living [ Time Frame: One year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Nursing Homes Study of Fall Risk Assessment Oriented to Intervention
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Accidental Falls
  • Activities of Daily Living
  • Quality of Life
  • Self-Efficacy
  • 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.
  • Experimental: Intervention
    Residents living in nursing homes allocated to intervention group. Assessment of risk factors. Implementation of a multifactorial tailored program to prevent falls.
    Interventions:
    • Other: Fall risk assessment
    • Other: Tailored intervention
  • Control
    Residents living in nursing homes allocated to control group. Assessment of risk factors. Receive the usual attention.
    Intervention: Other: Fall risk assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
331
April 2012
April 2012   (final data collection date for primary outcome measure)

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).
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00888953
FICE09041, PI08/90162, 645H
No
Fundacio Institut Catala de l'Envelliment
Fundacio Institut Catala de l'Envelliment
  • Fondo de Investigacion Sanitaria
  • Sociedad Española de Geriatría y Gerontología
Principal Investigator: Antoni Salvà Casanovas, MD Fundació Institut Català de l'Envelliment
Fundacio Institut Catala de l'Envelliment
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP