Patient FallEPICANCT01279525
Intervention to Reduce Falls Incidence
A study testing multifactorial in people with Patient Fall, run by Andalusian Regional Ministry of Health at 1 site in Spain.
Trial summary
The purpose of this study is to determine the effectiveness of a multifactorial intervention program to prevent falls among the elderly as compared to a brief intervention. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Fall
- What is being tested?
- multifactorial
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2005to Jan 2011
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients residing in the community
Who cannot join
- to be institutionalized
- Immobilized or bedridden
- Present a terminal disease or severe psychiatric illness
- Have contraindications to physical exercise
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad Docente de Medicina Familiar y Comunitaria
Córdoba, Cordoba, 14011
About this study
Official title: EFFECTIVENESS OF A MULTIFACTORIAL INTERVENTION PROGRAM TO REDUCE FALLS INCIDENCE AMONG COMMUNITY-LIVING ELDERLY PEOPLE
The purpose of this study is to determine the effectiveness of a multifactorial intervention program to prevent falls among the elderly as compared to a brief intervention.
Read the detailed description
The objective of this research is to verify if a simple multifactorial intervention program that is applicable in PC settings is more effective to decrease fall incidence than a brief advice for community-living people aged 70 or older.
- Conditions
- Patient Fall
- Being tested
- multifactorial
- Keywords
- Falls, Prevention, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifactorialDevice
individual advice, information leaflet, physical exercise workshop and home visits
| Study group | Role | What they receive |
|---|---|---|
| Multifactorial intervention | Experimental | Multifactorial intervention to prevent falls Receives: Device: multifactorial |
What is being measured
The primary outcome is the main question the study is designed to answer.
fall incidence rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2005
- Study completionJan 2011
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 Patient FallStudies 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
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Regional Ministry of Health
- Sponsor type
- Other government
- Collaborators
- Andalusian Society of Family Medicine, Spanish Society of Family and Community Medicine
- Investigators
- Luis A Pérula, Ph D, Principal investigator, Andalusian Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279525
- Sponsor's protocol ID
- 279/03
- Other IDs
- PI-279/03
- Acronym
- EPICA
- Status last verified
- Jan 2011
- First submitted
- 18 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Perula LA, Varas-Fabra F, Rodriguez V, Ruiz-Moral R, Fernandez JA, Gonzalez J, Perula CJ, Roldan AM, de Dios C; EPICA Study Collaborative Group. Effectiveness of a multifactorial intervention program to reduce falls incidence among community-living older adults: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Oct;93(10):1677-84. doi: 10.1016/j.apmr.2012.03.035. Epub 2012 May 15.
PubMed 22609117
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF A MULTIFACTORIAL INTERVENTION PROGRAM TO REDUCE FALLS INCIDENCE AMONG COMMUNITY-LIVING ELDERLY PEOPLE
- ClinicalTrials.gov ID
- NCT01279525
- Acronym / sponsor ID
- EPICA / 279/03
- Conditions
- Patient Fall
- Keywords
- Falls, Prevention, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Andalusian Regional Ministry of HealthOther government
- Collaborators
- Andalusian Society of Family Medicine, Spanish Society of Family and Community Medicine
- Study start
- Jan 2005
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Jan 2011 (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 purpose of this study is to determine the effectiveness of a multifactorial intervention program to prevent falls among the elderly as compared to a brief intervention.
Detailed description
The objective of this research is to verify if a simple multifactorial intervention program that is applicable in PC settings is more effective to decrease fall incidence than a brief advice for community-living people aged 70 or older.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifactorial intervention | Experimental | Device: multifactorialMultifactorial intervention to prevent falls |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients residing in the community
Key exclusion criteria (4 listed)
- to be institutionalized
- Immobilized or bedridden
- Present a terminal disease or severe psychiatric illness
- Have contraindications to physical exercise
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 |
|---|---|---|
| multifactorialindividual advice, information leaflet, physical exercise workshop and home visits | Device | Multifactorial intervention |
Primary outcome
fall incidence rate
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 19 Jan 2011.
- Derived from this study: PubMed 22609117Perula LA, Varas-Fabra F, Rodriguez V, Ruiz-Moral R, Fernandez JA, Gonzalez J, Perula CJ, Roldan AM, de Dios C; EPICA Study Collaborative Group. Effectiveness of a multifactorial intervention program to reduce falls incidence among community-living older adults: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Oct;93(10):1677-84. doi: 10.1016/j.apmr.2012.03.035. Epub 2012 May 15.
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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.
Luis A Pérula, Ph D principal investigator
Andalusian Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multifactorial in people with Patient Fall, run by Andalusian Regional Ministry of Health 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 1 inclusion and 4 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 19 Jan 2011. 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?
fall incidence rate. 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 NCT01279525, 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 19 Jan 2011.