Nursing Homes Study of Fall Risk Assessment Oriented to Intervention

NCT ID: NCT00888953

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 331 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Residents living in nursing homes allocated to intervention group. Assessment of risk factors. Implementation of a multifactorial tailored program to prevent falls.

Group Type: EXPERIMENTAL

Fall risk assessment

Intervention Type: OTHER

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

Intervention Type: OTHER

Induction of an intervention for each identified risk factor. If is possible the intervention will be directed towards the treatment of the underlying cause.

Control

Residents living in nursing homes allocated to control group. Assessment of risk factors. Receive the usual attention.

Group Type: OTHER

Fall risk assessment

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Mini Falls Assessment (MFA)

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Sociedad Española de Geriatría y Gerontología

UNKNOWN

Sponsor Role: collaborator

Fundacio Salut i Envelliment UAB

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoni Salvà Casanovas, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut Català de l'Envelliment

Locations

Fundació Institut Català de l'Envelliment.

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 25777945 (View on PubMed)

Other Identifiers

PI08/90162

Identifier Type: -

Identifier Source: secondary_id

645H

Identifier Type: -

Identifier Source: secondary_id

FICE09041

Identifier Type: -

Identifier Source: org_study_id