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Clinical Trials/NCT00888953
NCT00888953CompletedNot Applicable

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

Fundacio Salut i Envelliment UAB2 sites in 1 country331 target enrollmentStarted: May 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
331
Locations
2
Primary Endpoint
Number of fallers

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Outcomes

Primary Outcomes

Number of fallers

Time Frame: one year

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 Outcomes

  • Number of falls(one year)
  • Number of people who has a fracture as a consequence of a fall(one year)
  • Quality of life (only in residents without cognitive impairment).(One year)
  • Activities of daily living(One year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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