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
  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: 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 Institut Catala de l'Envelliment:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888953

Locations
Spain
Fundació Institut Català de l'Envelliment.
Barcelona, Spain, 08041
Sponsors and Collaborators
Fundacio Institut Catala de l'Envelliment
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

Additional Information:
No publications provided

Responsible Party: Fundacio Institut Catala de l'Envelliment
ClinicalTrials.gov Identifier: NCT00888953     History of Changes
Other Study ID Numbers: FICE09041, PI08/90162, 645H
Study First Received: April 27, 2009
Last Updated: June 12, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacio Institut Catala de l'Envelliment:
Falls
Nursing Homes
Elderly
Prevention
Spain
Cluster Randomized Clinical Trial

ClinicalTrials.gov processed this record on July 31, 2014