Nursing Homes Study of Fall Risk Assessment Oriented to Intervention (EMERCOIR)
Recruitment status was Active, not recruiting
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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 |
- 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
- 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)
|
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 |
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| Spain | |
| Fundació Institut Català de l'Envelliment. | |
| Barcelona, Spain, 08041 | |
| Principal Investigator: | Antoni Salvà Casanovas, MD | Fundació Institut Català de l'Envelliment |
More Information
Additional Information:
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 May 23, 2013