Older People Self-caring Through a Comprehensive Model Based on House Calls and Oriented Towards Falling Prevention (PM ACTIVAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Fall frequency
研究概览
简要总结
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.
详细描述
The comprehensive model PM ACTIVAS uses the house call to make a multidimensional assessment on the patient's falls risks factors (internal and external) and their falls risk perception in order to come up with a plan (together with the patient and their family, if present) to modify the hazards present at the patient's home. Together with a telephone follow-up to support the patient in their plan, it is expected that the patient would have a higher falls risk perception, lower falls risks present at home in order to prevent falling.
In the clinical trial, the sample will comprise of 220 high-functioning elderly people (from 65 to 80 years old) from the area which will be divided in two groups. The intervention group will receive a house call to perform the educational intervention with the PM ACTIVAS' model, while the control group will receive standard care from their health center. The research team will measure their internal and external falls risk factors and their falls risk perception at the beginning and at the end of the study. They will also receive a "Falling Prevention Kit" and a "Fall and Events Calendar" where they have to write every time they fall or trip and the day when it happened. At the end of the study, both groups will receive a house call to measure again their falls risk factors and perceptions in order to analyze if there has been any difference between groups regarding these factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Fall frequency
时间窗: T2 (1 year, final house call)
Number of falls registered on the " Falls and Events Calendar " in both the control and the intervention group. This calendar is a typical calendar where the patient and/or family have to write the days that the patient fell or tripped. The calendar was given to the patients at recruitment (T0) and have been taught how to register the falls, trips and related events in both groups. The research team will collect the data on the last house call (T2).
Management of external and internal falls risk factors
时间窗: T0 (recruitment) and T2 (1 year, final house call)
The research team will measure this with a previously validated checklist, which consists of 41 questions where the patient has to reply yes or no. The questions are related to internal and external falls risk factors. This survey will be applied at the recruitment (T0) and in the last house call (T2) in both control and intervention groups.
Perception on falls risk factors
时间窗: T0 (recruitment) and T2 (1 year, final house call)
The researchers will measure the perception that the patient has on falls risk factors in the home setting with a set of drawings where the patient has to identify what they consider as a falls risk factor. The research team will apply this at the recruitment (T0) and in the last house call (T2) in both control and intervention groups.
次要结局
未报告次要终点