Nursing Homes Study of Fall Risk Assessment Oriented to Intervention

Quality of Life Clinical Trial

— EMERCOIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888953
• Other study ID #: FICE09041
• Secondary ID: PI08/90162645H
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: June 12, 2013
• Start date: May 2009
• Est. completion date: April 2012

Study information

• Verified date: June 2013
• Source: Fundacio Salut i Envelliment UAB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls
• Activities of Daily Living
• Quality of Life
• Self-Efficacy

Intervention

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)
• 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.

Locations

Country	Name	City	State
Spain	Fundació Institut Català de l'Envelliment.	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundacio Salut i Envelliment UAB	Fondo de Investigacion Sanitaria, Sociedad Española de Geriatría y Gerontología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of fallers	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	No
Secondary	Number of falls	Number of falls per person/time.	one year	No
Secondary	Number of people who has a fracture as a consequence of a fall		one year	No
Secondary	Quality of life (only in residents without cognitive impairment).		One year	No
Secondary	Activities of daily living		One year	No