Accidental FallsNCT02177968
Public Health Concerns of Elderly Fallers and Non-fallers in a Community
An observational study of Accidental Falls and Aging, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to identify the prevalence and the characterization of health of elderly fallers and non-fallers in the southeastern community of Brazil in the state of São Paulo. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Aging
- What is being tested?
- descriptive analysis of characteristics
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Dec 2012
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- People aged 60 years and over
Who cannot join
- Vestibular alteration
- Postoperative requiring continuous home
- Low vision or complete blind
- Bedridden
- Empty house
- Subjects without registration at the health family unity
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Educação Permanente, Prefeitura Municipal de Araraquara
Araraquara, São Paulo
About this study
Official title: Public Health Concerns of Elderly Fallers and Non-fallers in a Southeastern Community of Brazil
The purpose of this study is to identify the prevalence and the characterization of health of elderly fallers and non-fallers in the southeastern community of Brazil in the state of São Paulo.
Read the detailed description
The population consisted of 638 elderly individuals enrolled and attended by the teams of the Family Health Strategy in the city of Araraquara, São Paulo state. The sample was selected in a systematic way, considering the order of micro-areas, 1-7, which 10% sampling error, 15% rate answer. To this, instruments were used based SABE Study, Health Wellbeing and Aging modified, and the International Physical Activity Questionnaire (IPAQ), short version.
- Conditions
- Accidental Falls, Aging
- Being tested
- descriptive analysis of characteristics
- Keywords
- fall, elderly, characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptive analysis of characteristicsOther
comparison between elderly fallers and non-fallers
| Study group | Role | What they receive |
|---|---|---|
| Elderly fallers or non-fallers | characteristics of these groups Receives: Other: descriptive analysis of characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy, Well-being and Aging questionnaire
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana Paludetti Zubieta Traldi, University of Sao Paulo
- Investigators
- Luciana PZ Traldi, research, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177968
- Sponsor's protocol ID
- HCRP9879/2011
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Public Health Concerns of Elderly Fallers and Non-fallers in a Southeastern Community of Brazil
- ClinicalTrials.gov ID
- NCT02177968
- Acronym / sponsor ID
- HCRP9879/2011
- Conditions
- Accidental Falls, Aging
- Keywords
- fall, elderly, characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jun 2014 (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 identify the prevalence and the characterization of health of elderly fallers and non-fallers in the southeastern community of Brazil in the state of São Paulo.
Detailed description
The population consisted of 638 elderly individuals enrolled and attended by the teams of the Family Health Strategy in the city of Araraquara, São Paulo state. The sample was selected in a systematic way, considering the order of micro-areas, 1-7, which 10% sampling error, 15% rate answer. To this, instruments were used based SABE Study, Health Wellbeing and Aging modified, and the International Physical Activity Questionnaire (IPAQ), short version.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly fallers or non-fallers | – | Other: descriptive analysis of characteristicscharacteristics of these groups |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- People aged 60 years and over
Key exclusion criteria (6 listed)
- Vestibular alteration
- Postoperative requiring continuous home
- Low vision or complete blind
- Bedridden
- Empty house
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 |
|---|---|---|
| descriptive analysis of characteristicscomparison between elderly fallers and non-fallers | Other | Elderly fallers or non-fallers |
Primary outcome
Healthy, Well-being and Aging questionnaire
Time frame: 5 months
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 30 Jun 2014.
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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.
Luciana PZ Traldi, research principal investigator
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 Accidental Falls and Aging, run by University of Sao Paulo at 1 site in Brazil.
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 6 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 30 Jun 2014. 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 Brazil. 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?
Healthy, Well-being and Aging questionnaire (time frame: 5 months). 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 30 Jun 2014.