FallNCT03361059
Falling Risks in Elderly Adults : a Prospective Cohort Study
An observational study of Fall, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.
Trial summary
Introduction: the prevalence of falls in adults aged 65 years or older living in the community is 30%, being the second cause of accidental fatal injury and the fifth cause of death. About 20 to 30% of falls result in injuries: 10% constitute serious injuries, from which 5% are fractures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall
- How many people
- 600 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Mar 2017to 15 Aug 2018
- Phase
- Observational
- 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
- Older adult
Study population: outpatient elderly patients of 65 years or more living in the community
Who may be able to join
- Patients of 65 years or more treated at the Physical Therapy outpatient consult of the " Hospital Francisco Santojanni" that they walk at least inside their home and have signed informed consent
Who cannot join
- patients who walk with partial body weight load
- patients using a lower limb immobilization device
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Donación Francisco Santojanni
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1408INH
About this study
Official title: Falling Risks in Elderly Adults: a Prospective Cohort Study
Introduction: the prevalence of falls in adults aged 65 years or older living in the community is 30%, being the second cause of accidental fatal injury and the fifth cause of death. About 20 to 30% of falls result in injuries: 10% constitute serious injuries, from which 5% are fractures. As a result, older adults decrease their mobility, are afraid of falling depressed and socially isolated, increasing the risk of later falls, death and health costs. Falls and their consequences can be prevented, so knowing and assessing the demographic, medical, self-perceived and functional characteristics constitutes an important information for health professionals. Given the high rate (29.59%) of older adults treated at the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni" and the relevance of falls in this population, it is convenient to take a behavior and start by knowing their risk characteristics.
Objectives: to determine the incidence of falls of adults aged 65 years and older, seen in the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni"; to describe the characteristics of these population and to identify the potential risk-of-falling factors.
Subjects and Methods: observational, prospective, longitudinal cohort study. Demographic (age and sex), medical (history of falls, visual alterations, medication and walking aids), self-perceived (fear of falling and instability perception) and functional characteristics (Test of Timed up and Go, Dynamic Index of gait and balance tests) will be evaluated in those patients of 65 years or more who initiate physical treatment in the outpatient consult of the of the "Hospital Francisco Santojanni" "Autonomous City of Buenos Aires, from March 2017 to February 2018, with a follow-up of 6 months until August 2018, to verify the development of the fall event
- Conditions
- Fall
- Keywords
- risk factors, elderly patients, risk of falling
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall
an event that results in a change of body position that forces a person to make contact with the ground or other support surface at a lower level, unintentionally and unexpectedly, without being the consequence of an important intrinsic event (such as loss of consciousness, sudden onset of paralysis or epileptic seizure), or unavoidable external danger (such as the collapse of a chair or violent blow). The outcome variable will be measured by a phone call.
Measured: From May 2017 to August 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start15 Mar 2017
- Primary completion19 May 2018
- Study completion15 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Donación Francisco Santojanni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Di Giorgio, Hospital Donación Francisco Santojanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361059
- Sponsor's protocol ID
- HGADFS11052017-01
- Status last verified
- May 2018
- First submitted
- 10 Nov 2017
- Last updated
- 23 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falling Risks in Elderly Adults: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03361059
- Acronym / sponsor ID
- HGADFS11052017-01
- Conditions
- Fall
- Keywords
- risk factors, elderly patients, risk of falling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospital Donación Francisco SantojanniUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 19 May 2018 (actual)
- Study completion
- 15 Aug 2018 (estimated)
- First posted
- 4 Dec 2017 (actual)
- 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.
Introduction: the prevalence of falls in adults aged 65 years or older living in the community is 30%, being the second cause of accidental fatal injury and the fifth cause of death. About 20 to 30% of falls result in injuries: 10% constitute serious injuries, from which 5% are fractures. As a result, older adults decrease their mobility, are afraid of falling depressed and socially isolated, increasing the risk of later falls, death and health costs. Falls and their consequences can be prevented, so knowing and assessing the demographic, medical, self-perceived and functional characteristics constitutes an important information for health professionals. Given the high rate (29.59%) of older adults treated at the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni" and the relevance of falls in this population, it is convenient to take a behavior and start by knowing their risk characteristics.
Objectives: to determine the incidence of falls of adults aged 65 years and older, seen in the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni"; to describe the characteristics of these population and to identify the potential risk-of-falling factors.
Subjects and Methods: observational, prospective, longitudinal cohort study. Demographic (age and sex), medical (history of falls, visual alterations, medication and walking aids), self-perceived (fear of falling and instability perception) and functional characteristics (Test of Timed up and Go, Dynamic Index of gait and balance tests) will be evaluated in those patients of 65 years or more who initiate physical treatment in the outpatient consult of the of the "Hospital Francisco Santojanni" "Autonomous City of Buenos Aires, from March 2017 to February 2018, with a follow-up of 6 months until August 2018, to verify the development of the fall event
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- outpatient elderly patients of 65 years or more living in the community
Key inclusion criteria (1 listed)
- Patients of 65 years or more treated at the Physical Therapy outpatient consult of the " Hospital Francisco Santojanni" that they walk at least inside their home and have signed informed consent
Key exclusion criteria (2 listed)
- patients who walk with partial body weight load
- patients using a lower limb immobilization device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fall
Time frame: From May 2017 to August 2018
an event that results in a change of body position that forces a person to make contact with the ground or other support surface at a lower level, unintentionally and unexpectedly, without being the consequence of an important intrinsic event (such as loss of consciousness, sudden onset of paralysis or epileptic seizure), or unavoidable external danger (such as the collapse of a chair or violent blow). The outcome variable will be measured by a phone call.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.
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 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: status not confirmed, as of the sponsor's last update on 23 May 2018. 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 Argentina. 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?
Results are not available in the source record.
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 (time frame: From May 2017 to August 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2018.