Clinical trial NCT00888953: Nursing Homes Study of Fall Risk Assessment Oriented to Intervention
Official title: Estudio de Medida Del Riesgo de Caídas Orientada a la Intervención en Residencias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Activities of Daily Living
Quality of Life
Self-Efficacy
Keywords: Falls
Nursing Homes
Elderly
Prevention
Spain
Cluster Randomized Clinical Trial
Lead sponsor: Fundacio Salut i Envelliment UAB
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
name: Sociedad Española de Geriatría y Gerontología
First posted: 2009-04-28
Enrollment: 331
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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).

Primary outcomes:
measure: Number of fallers
timeFrame: one year
Secondary outcomes:
measure: Number of falls
timeFrame: one year
measure: Number of people who has a fracture as a consequence of a fall
timeFrame: one year
measure: Quality of life (only in residents without cognitive impairment).
timeFrame: One year
measure: Activities of daily living
timeFrame: One year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació Institut Català de l'Envelliment.
Study officials:
affiliation: Fundació Institut Català de l'Envelliment
name: Antoni Salvà Casanovas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salva A, Rojano X, Coll-Planas L, Domenech S, Roque I Figuls M. [Randomized clinical trial of a fall-prevention strategy for institutionalized elderly based on the Mini Falls Assessment Instrument]. Rev Esp Geriatr Gerontol. 2016 Jan-Feb;51(1):18-24. doi: 10.1016/j.regg.2015.02.001. Epub 2015 Mar 14. Spanish.