Falling Prevention Comprehensive Model for Older People Self-caring (NCT04313062) | Clinical Trial Compass
CompletedNot Applicable
Falling Prevention Comprehensive Model for Older People Self-caring
Chile220 participantsStarted 2021-01-07
Plain-language summary
Falls in elderly people are a public health problem and in Chile there's a deficit regarding prevention strategies focused on high functioning older people who live in the community. The aim of the study is to design, implement and evaluate a comprehensive model based on house calls and oriented towards falling prevention (PM ACTIVAS' model). The researchers will perform a clinical trial in a district of Santiago, Chile to evaluate this model. Our hypothesis are that people who received the educational intervention following the PM ACTIVAS' model will: fall less frequently, improve their management on falls risk factors present at home, and have a higher falls risk perception than the control group. The researchers also expect that it will be possible to establish cut off points in a valid and reliable scale to assess the presence of falls risk factors in elderly people.
Who can participate
Age range
65 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Older people who has 43 points or more in the elderly functionality test \[Examen de Funcionalidad del Adulto Mayor: EFAM\] part A test (a chilean validated test that assesses functionality) at recruitment.
Exclusion Criteria:
* Older people whose address does not belong to the health center's territory.
* Older people who have any visual or hearing impairment that hinders effective communication
* Older people with depression or any mild to severe mood disorder stated in their health physical record booklet or drug registry booklet.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fall frequency
Timeframe: T2 (1 year, final house call)
2
Management of external and internal falls risk factors
Timeframe: T0 (recruitment) and T2 (1 year, final house call)
3
Perception on falls risk factors
Timeframe: T0 (recruitment) and T2 (1 year, final house call)