Nursing Homes Study of Fall Risk Assessment Oriented to Intervention - Full Text View

Sponsor:	Fundacio Institut Catala de l'Envelliment
Collaborators:	Fondo de Investigacion Sanitaria Sociedad Española de Geriatría y Gerontología
Information provided by:	Fundacio Institut Catala de l'Envelliment
ClinicalTrials.gov Identifier:	NCT00888953

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:

MedlinePlus related topics: Falls Nursing Homes

U.S. FDA Resources

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 ]

Estimated Enrollment:	760
Study Start Date:	May 2009
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (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.
No Intervention: 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)

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.

No Intervention: 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

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:

Web page with studies about falls carried out by the Fundació Insititut Català de l'Envelliment . This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Antoni Salvà Casanovas, 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 21, 2010
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 February 09, 2012