Accidental FallsEMERCOIRNCT00888953
Nursing Homes Study of Fall Risk Assessment Oriented to Intervention
A study testing Fall risk assessment and Tailored intervention in people with Accidental Falls and Activities of Daily Living, run by Fundacio Salut i Envelliment UAB at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Activities of Daily Living, Quality of Life
- What is being tested?
- Fall risk assessment and Tailored intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteSpain
- Study dates
- May 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Institut Català de l'Envelliment.
Barcelona, Barcelona, 08041
About this study
Official title: Estudio de Medida Del Riesgo de Caídas Orientada a la Intervención en Residencias
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.
Read the 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.
- Being tested
- Fall risk assessment, Tailored intervention
- Keywords
- Falls, Nursing Homes, Elderly, Prevention, Spain, Cluster Randomized Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall risk assessmentOther
Also called Mini Falls Assessment (MFA)
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 interventionOther
Induction of an intervention for each identified risk factor. If is possible the intervention will be directed towards the treatment of the underlying cause.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Residents living in nursing homes allocated to intervention group. Assessment of risk factors. Implementation of a multifactorial tailored program to prevent falls. Receives: Other: Fall risk assessment; Other: Tailored intervention |
| Control | Other | Residents living in nursing homes allocated to control group. Assessment of risk factors. Receive the usual attention. Receives: Other: Fall risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (4)
Number of falls
Number of falls per person/time.
Measured: one year
Number of people who has a fracture as a consequence of a fall
Measured: one year
Quality of life (only in residents without cognitive impairment).
Measured: One year
Activities of daily living
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Salut i Envelliment UAB
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Sociedad Española de Geriatría y Gerontología
- Responsible party
- Sponsor
- Investigators
- Antoni Salvà Casanovas, MD, Principal investigator, Fundació Institut Català de l'Envelliment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888953
- Sponsor's protocol ID
- FICE09041
- Other IDs
- PI08/90162, 645H
- Acronym
- EMERCOIR
- Status last verified
- Jun 2013
- First submitted
- 27 Apr 2009
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25777945
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio de Medida Del Riesgo de Caídas Orientada a la Intervención en Residencias
- ClinicalTrials.gov ID
- NCT00888953
- Acronym / sponsor ID
- EMERCOIR / FICE09041
- Keywords
- Falls, Nursing Homes, Elderly, Prevention, Spain, Cluster Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Fundacio Salut i Envelliment UABUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Sociedad Española de Geriatría y Gerontología
- Study start
- May 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Fall risk assessment, Other: Tailored interventionResidents living in nursing homes allocated to intervention group. Assessment of risk factors. Implementation of a multifactorial tailored program to prevent falls. |
| Control | Other | Other: Fall risk assessmentResidents living in nursing homes allocated to control group. Assessment of risk factors. Receive the usual attention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fall risk assessmentAlso: Mini Falls Assessment (MFA)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 | Control, Intervention |
| Tailored interventionInduction of an intervention for each identified risk factor. If is possible the intervention will be directed towards the treatment of the underlying cause. | Other | Intervention |
Primary outcome
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
4 secondary outcomes
Number of falls
Time frame: one year
Number of people who has a fracture as a consequence of a fall
Time frame: one year
Quality of life (only in residents without cognitive impairment).
Time frame: One year
Activities of daily living
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
- Derived from this study: PubMed 25777945Salva 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.
- Web page with studies about falls carried out by the Fundació Insititut Català de l'Envelliment .Link provided by the sponsor.
Related trials for Accidental Falls
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of the PPAL
Age Problems
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Salvà Casanovas, MD principal investigator
Fundació Institut Català de l'Envelliment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall risk assessment and Tailored intervention in people with Accidental Falls and Activities of Daily Living, run by Fundacio Salut i Envelliment UAB at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fallers (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.